Within System Form Designer, you can create and edit customizable application form(s), reviewer’s forms, and study submission forms. These forms can be made available to research studies as well as the review board depending on the type of form and the access assigned to the form. Additionally, access can be set based on a user’s role within iRIS and whether that role will have read only rights to the form or full access to create and submit the form.

The Concept of Forms

Note: Skip this section if you are familiar with iRIS and already understand the concept of the System Form Designer.

The Forms Designer is a unique tool that allows you to build fillable forms that will be used to capture and submit data throughout the system. Once finished, the forms can be published to the system and made available to users as needed. Each iRIS system comes with an already completed set of basic forms filled with generic information. Prior to the implementation of your software these forms are customized to match your institutions specific form data, provided that your institution has submitted these forms to iMedRIS.

Form Data

In order to understand the concept of the forms designer it will be helpful to first demonstrate how a form is displayed in iRIS by using a form that has already been completed. The example form is based on a generic topic (the topic chosen will be a survey regarding the weather). The image below shows the first Section of a form (section 1.0), a Question (question 1.1) with the label “What was the Weather like outside today?” and a Data Value where a user can input information. (You are able to select the type of data value that you want displayed for users as explained in more detail below).

 

Note: The screen shot above shows that a Single Selection Data Value has been provided to the user which will allow the user to select one single answer (“Cloudy”, “Rainy” or “Sunny”) in answer to the question “What was the Weather like outside today?”

Sections

Any number of sections can be configured within the form. Each section will contain a series of questions to present to the user.

 

When you complete a section, click the Save and Continue to Next Section button. As sections are completed, navigation will build in the form menu to the left of the current form section.

Note: Sections displaying the Navigation and Save and Continue to the Next Section button can only be built into forms, if “Wizard Form” was selected when the form was first being created. Otherwise, the form sections all display in one screen and the user would use the scroll bar to navigate to other portions of the form. This will be explained in further detail in subsequent sections.

Questions

During the configuration of forms, you are able to build as many questions (per section) as needed. Questions are not necessarily always an actual question; this can be whatever text you wish to display to the users. For example, the image below could have presented the data “Enter the humidity level in the field below” rather than the question “How was the humidity level?”

Keep in mind, as you configure questions within your form, data values are associated to the questions and need to be setup according to how you want them displayed to your users. The numerical display of questions is based on the section that the question is associated to. For instance, if a question is in section 2.0, as seen in the image above, it will display as question 2.1, and any additional questions within this section will build from 2.1 to 2.2, 2.3, etc.

Data Values

During the configuration of forms, Data Values are setup within specific questions. Data Values are selected from a list of available Data Types, (examples of some basic data value types include: Text Fields, Date Selection, Single Selection, Multi Selection), meaning the type of data that you want displayed for your users input in response to the question presented to them.

Questions can be setup with as many data values as needed, although, these values do not build numerically like the questions and sections, rather they simply display select values to the user for input, as seen in the images above.

Branching

During the configurations of a form, there are also branching configurations that can be set up. Branching is a tool that allows you to direct users to specific sections based on the user input in previous questions.

Note: Branching paths are performed by the software (based on the rules you have built) when the user clicks the Save and Continue to Next Section button from one section to another.

For example, the Weather Survey Form has been setup with additional sections for Cloudy, another section for Rainy, and another section for Sunny. Branching rules have been built into this form telling the system to display the Cloudy section if “Cloudy” was selected by the users in the very first section (1.0). If “Rainy” was selected in 1.0, the Rainy section is displayed and if “Sunny” was selected in 1.0, the Sunny section will display.

The image below shows the Weather Survey form being filled out on a user’s end with the “Cloudy” option selected in the single selection data value available to the users in section 1.0.

 

After the user selects Save and Continue to the following section, the system will automatically display the Cloudy section next as section 2.0.

 

The screenshot below shows that the “Rainy” option was selected in section 1.0.

 

When the user selects Save and Continue to the following section, the next section will display as Rainy and will be numbered section 2.0, as seen in the image below.

 

Many combinations of branching rules can be built into forms for numerous data value types. Steps to configure these rules are explained later in this manual.

Show Visibility

Show Visibility allows you to setup rules to display questions and data values only if a question is answered a certain way in the current form section. This is similar to Branching; however, instead of directing a user to a different section, Show Visibility will display questions and data values within the same section.

Rules are created and associated to Questions or Data Values so that information will only display if the answer to a certain question is “Yes”. The screenshot below has a Show Visibility rule setup and applied to a question with several data values. This rule tells the system to only display the information if the answer to the Yes/No selection question is “Yes”.  Here, the user selected “Yes” when asked “Do you live near a beach?”  In response, the system will show section 2.3 which includes questions about the beach.

 

If the value used is not selected or “No”, the question with Beach Questions will not display in the form.

 

Many combinations of rules can be built into forms for numerous data value types. Steps to configure these rules are explained later in this manual.

Validation

In addition to setting up the questions, data values, branching, and show visibility of a form as described above, there are also Validation configurations that area available. Validation is a tool that allows you to require additional information from users. The system will present users with an error message and not allow the form to continue if the information you have setup in a validation rule has not been completed.

For example, as seen in the image below, the Rainy section in the Weather Survey Form has been setup with 2 data values in answer to the question “Did you wear a rain coat?”

1 – The first data value that is configured in this question is a Yes / No selection. This will allow the user to select either “Yes” or “No” in response to the question.

2 – The second data value that is configured in this question is a single line text field. This will allow the user to enter text information. This data value was also configured with additional instructions presented to the user “If Yes, what color was your rain coat?”

 

This form has been setup with a validation rule telling the system that if the user selects “Yes”, to the Yes / No data value, the user is required to also fill out the text field. If the user attempts to save and continue to the following section without filling out this information, the system will display an error message. The user will be required to fill out the needed information before continuing within the form, as seen below.

Many combinations of validation rules can be built into forms for numerous data value types. Steps to configure these rules are explained later in this manual.

System Form Designer

 

The System Form Designer can be found under the System Administration tab.

Existing Forms

After opening the System Form Designer, a page listing of all the forms in the system will appear (10 per page), as seen below. You can designate the types of forms that you wish to view in the form library by selecting them from the available drop down filter list at the top of the screen or enter in all or part of either the Form Name or Table Name and then click the Find button.

 

The columns on this screen are as follows:

Show Review Sections – If a Review Board section has been created for a form, a yellow folder will appear in this column. Click this folder to expand and view the Review Board section. Click again to minimize the folder.

Add Review Section – Click the icon in this column to build a review section that the review board will complete.

Show History – If more than one version of a form has been published, a folder will display in this column. The folder can be expanded to display older versions in read-only format. The older versions can be viewed by clicking the Edit icon.

Edit – This icon will bring you to the form’s main configuration screen. From here all of the form’s main configurations are available, including sections, questions, data values, branching, and validation rules.

Form Name/Table Name – The top name, appearing in bold, will be used to reference the form wherever it appears in iRIS. The bottom name is the table name. Some of the forms allow the creator to designate the name of the data table where the form will be saved. The table name does not allow for spaces (notice the underscores used), or special characters.

Version – When a form has been initially created it is labeled as version number 1. Every time the form is unpublished for editing and then republished the system increases the version number by 1. This allows the system administrator to keep track of how many times a form has been edited. Note that all users of an old version will continue using that specific version until they create a new form or choose to transfer to the new version, which will then give the user access to the newest version.  

Form Type – Displays the type of form associated with the Form Name. See below for form definitions.

Category & Group – These fields display the Category and Group that a form has been placed in. Categories and Groups can be created and associated to forms, so that they are displayed as needed in the Study Management area of Study Assistant. The configurations for these are demonstrated later in this manual.

Form Status – Shows you the status of the form with the two possible options being Active and Update. If the form is in Update mode AND has not yet been published, the latest version will not appear in the Study Management screen until it has been published. Once active, a form can be brought back to Update mode by creating a new version in order to make revisions. Until that form is published again the last published version will be accessible by the Study Management users. Active indicates that the most recent publication is being used.

Form Types

Different form types are used for different types of functionality in the system. A submission form is used to gather information and is submitted in a workflow to a reviewing board. A reviewer form is used to gather information from an assigned reviewer. Forms can be setup to present information to a user when electronically signing off on a submission form. When you add a new form to the system (System Form Designer -> Operations -> Add a New Form) you will need to select which type of form to add. The list below describes the different form type options. Your system may or may not have the same types available, depending on which modules are turned on in your system.

Project Interview

The Project Interview form is used to collect data for a new proposal for funding. When you choose this type of form, you will be prompted for the same information as described below for the Study Interview. This option will only be available if your instance of iRIS is using the eProposal Assistant.

Study Interview

This form type is used to collect data for a New Study. An example of what this form type would be used for is your Study Application Form.

Note: Modules IRB, IACUC, IBC, SRB, RSC will use the Study Interview to define the application used to create a research study. Each module can have a separate application or can combine applications into one form and use branching logic to direct users to necessary sections based on which review boards will be involved in the study. Before configuring multiple applications in the system, make sure the setup used (one application, or multiple applications) will be the best method for your institution. Your iMedRIS Project Manager will assist with this determination.

When selecting a Study Interview, you must create a Submission Form Name. This will be the form display name and can be changed later if needed. You must also enter the database table name. This field will be the name of the table created to store the form information in the database. This field cannot contain spaces or special characters and is not editable after it has been saved. Next, designate the Navigation name which is the navigation link that will display at the top of the screen when users are filling out the form, as seen in the image below. Additionally, the Application Type must be selected from the dropdown menu (Research Application, IRB, Emergency Use Application, etc.).

Project Submission Form 

This form type is used for any eProposal project form that needs to be submitted to the eProposal Assistant for review. Building a Project Submission form follows the same steps described below for the Study Submission Form type. This option will only be available if your instance of iRIS is using the eProposal Assistant.

Project Attachment/Sub Form

This form type is used for any eProposal project form that needs to be attached to a Project Submission Form. Building a Project Attachment / Sub Form follows the same steps described below for the Study Attachment / Sub Form type. This option will only be available if your instance of iRIS is using the eProposal Assistant.

Study Submission Form

Any form that needs to be submitted to a review board from a research study qualifies as a Study Submission Form.

Note: modules IRB, IACUC, IBC, SRB, RSC will use Study Submission Forms.

When you select the Study Submission Form type, a new page will open. You can select which method to use to create the form in the system: Predefined Submission Forms or New Submission.

The Predefined Submission Forms option provides a drop-down list of available forms to choose from. Each form type can only be used once, so once you choose a record from this drop-down list and create the form, the form type will not appear in the list the next time you build a Study Submission Form. This option is helpful for building commonly used forms for the IRB; Adverse Events, Continuing Review, Protocol Deviation, etc.

The New Submission option allows you to create your own form. This option allows more flexibility with the form definition.

When you choose this option, you will need to provide the following information:

Submission form name – Enter the name of the form here. This is the display name of the form.

Submission form database table name – Enter the database table name. When you create the form in the system, a table will be inserted into the database, using the name entered here along with a system generated name. For example, if the table name entered above is “WEATHER”. When the form is created, the name of the table in the system will be “GEN_ST_SUB_WEATHER”. Note: the database table name must be uppercase alpha characters. Spaces and special characters cannot be added to the name.

Navigation name – Enter the navigation name in this field. This is the link that will display within the system navigation for the main iRIS header, as shown below.

Wizard form – Use this option to set your form into Wizard form mode. When the form is in Wizard mode, one section at a time will be presented to the user. As each section is completed, the user will click the Save and Continue to the Next Section button. Note: if you are going to use Branching within the form, the Wizard option must be set to “Yes”.

When the Wizard option is set to “No”, all the sections in the form will be presented to the user on one page. The user can use the scroll bars on the page to navigate the form and complete each section. Only the Save Form button will be available to save the entire form. This option is ideal for short forms that do not require branching logic.

Study Attachment/Sub Form

This form type is used for study forms that will be attached to other forms. Attachment forms are built the same as other forms, but then associated to the parent form using a data value. When a user completes the parent form, they will be presented with the option of filling out and attaching this form type.

Submission Signoff Routing Forms

Most commonly used for investigator assurances or financial disclosures, these forms are used to create a signoff page and designate its use towards a particular role and form. This form requires manual input of form name and database table name.

These forms are user role defined (example: specifically displayed for the Principal Investigator, Study Contact, etc.) and are associated to a specific submission form. After the form has been created, setting up the user roles for these forms can be done from the main form designer list. When a routing form has been added to the system, the system will display a separate icon in the Add Review Section column, as seen in the image below.

When you click the icon in the Add Review Section column, a new page opens. From here you can set the form to associate the routing form to and what role the routing form should display for.

When a user with the specified role is applying their electronic signature to the submission form chosen, the routing form will display. The information in the image below shows a routing form displayed on the signoff page of the Weather Form for the Principal Investigator.

Notes:

More than one role can be associated to a routing form however; a routing form cannot be associated to more than one submission form.

To associate a routing form to a Study Interview (Study Application) you will need to associate the routing form to the Initial Review Submission Form. Study Interview forms are not routed in the workflow but are attached to the Initial Review Submission Form.

Non–Study Submission Forms

Forms of this type are designed for submitting information/issues to the review board that are not related to any particular study. They are available to users in the “Special Purpose Submissions Form(s)” menu item in the software.

Non–Study Attachment/Sub Forms

Forms of this type are used to store information, such as compliance issues unrelated to a project or a study. This form is NOT submitted to a review board but is simply kept as a record. They are available to users in the “Special Purpose Submissions Form(s)” menu item in the software.

Conflict of Interest Annual Form

This form type is to collect the annual disclosure information from Covered Persons. This form type is only available with the COI Assistant module.

Conflict of Interest Study Disclosure Form

This form type is to collect disclosure information from personnel on a study. This form type is only available with the COI Assistant module.

Conflict of Interest Project Disclosure Form

This form type is to collect disclosure information from personnel on a project. This form type is only available with the COI Assistant module.

Conflict of Interest Miscellaneous Disclosure Form

This form type is to collect disclosure information from personnel in addition to the Annual Form. These forms could be submitted any time but would not count towards the user’s Annual COI Due Date. This form type is only available with the COI Assistant module.

Conflict of Interest Non-User Disclosure Form

This form type is to collect business and institutional disclosure information for COI review. This form type is only available with the COI Assistant module.

ARC Submission Form

This form type is used to collect information within an animal study for ARC review. This form type is only available with the ARC Assistant module.

ARC Animal Order Form

This form type is used to collect new Animal Orders from studies using animal management. This form type is only available with the ARC Assistant module.

ARC Animal Internal Transfer Form

This form type is used to request animal transfers within the institution. This form type is only available with the ARC Assistant module.

ARC Animal External Transfer Form

This form type is used to request animal transfers to/from outside facilities. This form type is only available with the ARC Assistant module.

Review Board Reviewer’s Form

The Review Board Reviewer’s form is used to collect information from board members for specific submission reviews. When a reviewer is assigned to a submission, the form defined here will be presented to the user. Only one form of this type can be created per review board and the boards available in the drop-down list are limited to the review boards defined in your system.

There are a variety of distinct data types available when creating this form. These data values allow reviewers to: view the contents of the submission (including all components), view a list of all reviewers, add comments, check off whether the review has been completed, view the submission reference number, view any Shared Committee forms or letters, and link Submission details (Stipulations, Outcome, Approval, Follow-up). These Data Values are all explained later in this manual within the Data Value Definitions area.

Note: When creating this form there are specific data types that are available for only the Review’s Form, these specific data values are described in the data value definitions at the end of this manual.

Review Board Pre-Review Correction Form

This form is available to Study users for Pre-Review corrections to a submission for a particular review board. Upon selecting this form type, you will select the review board for which this particular form will be used.

Note: When creating this form, there are specific data types that are available for only the Pre-Review Correction Form and the Review Response Form, these specific data values are described in the data value definitions at the end of this manual.

Review Board Review Response Form

This form is available to Study users for review response corrections to a particular review board. Upon selecting this form type, you will select the review board for which this particular form will be used.  

Note: When creating this form, there are specific data types that are available for only the Pre-Review Correction Form and the Review Response Form, these specific data values are described in the data value definitions at the end of this manual.

Review Board Outcome Form

This form is a new feature which allows for configurable questions/fields to be added into the Outcome tab of a submission has been added to iRIS. To add additional questions/fields to the Outcome tab, a form must be created within System Form Designer. When the “Add a New Form” selection is made, as shown in the image below, another screen allowing the user to select the type of form is prompted. The “Review Board Outcome Form” selection must be chosen, and upon selecting this form type and saving the selection, another screen will be displayed where the user must select the review board that this outcome form will be used for. After the form is created, the form will be displayed in a section within the outcome tab of the submission for the selected review board.

 

Creating a Form

You can add a new form by navigating to System Form Designer -> Operations -> Add a New Form. You will need to select the form type and enter the necessary information.

After selecting the appropriate form type (as demonstrated in the above section) and entering the necessary information, the form will be created.

Forms contain left side navigation. The default view is Section List, which will display the current sections within the form on the right side of the screen. For a new form, no sections will display in this screen. Use the buttons on the left to navigate to various functions of the form; to Edit form details, setup form tool tips, define branching, etc.

Buttons on the top of the page control certain functionality of this form.

Both the items on the left and the buttons at the top of the page will be described throughout this document.

Form Content

Add Section

The first step for creating a new form is to define the sections for the form. A section within the form is a dividing section of a form that will contain questions and data values. The screenshot below shows the green header as the first section of a form. Below the section the defined questions and data values within that section display. Before you can define the content of the section, you first create the section shell, as described below.

Click the Add Section button. A screen similar to the image below will open. From here you will add the Section Text, Section Name, and change the Section Order, if necessary. When you are finished, click the Save Section Changes button, or click the Cancel – Return to List button to return to the Section List page.

Note: Section Ordering defaults by 100s. Example, in a new form, the first section created will have the Section Order of 100. The next section created will have Section Order 200, and so on.

Once a section is initially saved, additional options will display on the page, as shown in the image below.

Sections that are defined in the form will display in the main part of the Section List page, as shown in the image below.

The Sections defined within the form can be reordered using the Section Order column. The Section Order can be changed by typing in the new section order then clicking on the Save Section Order button.

You can view the questions within a specific section by clicking on the icon within the Expand Details column.

Any Branching, Validation, and Show Visibility rules defined in this section will also be summarized in the expanded section view, as shown in the screenshot below. Note: the screenshot below shows a form that has Sections, Questions, Branching, Show Visibility, and Validations defined. If this information has not been defined within your form, the details will not display that data.

You can access the details for Questions, Branching, Show Visibility, and Validation by clicking the icon in the Edit column.

Sections can be removed from the form by clicking on the icon in the Remove Section column. A window will open within the browser asking for confirmation before removing the section from the form. Click OK to continue removing the section. Click Cancel to keep the section.

Note: Before removing a section from a form, it is advised that you create a backup of your form (see the Export/Import section) in case you remove a section unintentionally and would like to restore it.

Section text can be modified by clicking the icon in the Edit column. This will open the Section Definition page.

To make any changes to the section, including section text, questions, data values, branching, validation, or show visibility, you will access the section by clicking this icon to make these changes.

When you add or edit a section, you will be navigated to the Section Definition page, as shown in the screenshot below. From this area you can input the section title information, define the questions, branching, show visibility, validation, or exclude rules. Each of these areas is accessed using the menu to the left of the main page.

 

Section Definition

Whether you are adding a new section or modifying an existing, you can use the Section Definition to change the Section Title, Section Name, and Section Order.

Section Text – Text entered in this field will display as the section header within the form.

Section Name – The text entered in this field will display as the Section Name in the navigation within the form.

The Section Name will also display for the View Branching.

Section Order – This field allows you to set the section order. Section Ordering defaults by 100s. Example, in a new form, the first section created will have the Section Order of 100. The next section created will have Section Order 200, and so on. You can reorder sections by changing the number here.

When you finish making changes to the section, click the Save Section Change(s) button.

Add Section Questions

After defining the sections within the form, you can add the questions to each section. To add a question to a section, navigate to the section by clicking on the Edit icon for the appropriate section. When the Section Definition page opens click on the Section Question menu item.

Any questions defined within this section will display within the Section Questions page. From here you can modify existing questions and add new questions. Questions can also be removed by clicking the icon in the Remove Question column. To add a new question, click the Add Question button.

A screen similar to the image below will open. From here you will add the Question Text, and change the Question Order, if necessary. When you are finished, click the Save Question Changes button, or click the Cancel – Return to List button to return to the Section Questions page.

Note: Question Ordering defaults by 10s. Example, in a new form, the first question created within the section will have the Question Order of 10. The next question created will have Section Order 20, and so on.

The Visibility Dependency drop down list is used to designate if this question should be included in a Show Visibility rule. This will not be used when initially creating a form. Once you have the form sections, questions, and data values defined you can add the form logic.

Question Definition

When you finish making changes to the question, click the Save Question Changes button. Once the question is initially saved, additional items will be available for the question, and will be accessible on the left side of the page.

You also have the ability to Copy Question to a New Form and Move Question to a New Section. These options are available if you need to move a question.

Copy Question to a New Form – A window within the browser will open displaying the Current Question Text. Select a form from the Choose the Form to copy the question to drop down list. Once you select a form, values will populate in the Choose the Section to move the question to drop down list. Select the section then choose a value for the Question Order in the Enter a new question number field. Click Save the Question Copy to copy the question to the selected form and section. You can click the Cancel button to close the window and return to Question Definition without copying the question.

Notes:

In order to copy a question to a form, the destination form must be in an unpublished state. If you do not see the name of the destination form in the Choose the Form to copy the question to drop down list, check to see if the destination form is published.

If you copy a question that has Data Column Names that are also defined in the destination form, the copy will not proceed. An error message similar to the message in the screen shot below will display and the copy will cancel.

Move Question to a New Section – If the question you added needs to be in a different section, you can move it to the appropriate section within the form by clicking this button. A new window will open within the browser. From here you can choose another section within the form and specify the new question order number. When you Save the Question Move the question text and data values within the question will move to the specified section.

Add Question Data Values

Data Values allow you to either create an area for the user to enter information or configure the system to pull study or project information into the form. Additionally, Data Values can be used to give users options to upload documents such as consent forms, other study documents, and many more options.

Data values are added to questions within sections. You can have more than one data value per question.

Note: For additional information regarding the concept of Data Values, select the link The Concept of Forms.

Click the Add a New Data Value button.

A new page will open displaying the Data Value Details, as seen in the image below.

When you define a data value in the form, you need to specify several data points. Each is described below.

Question Text – The value entered on the previous page for the Question Text is shown at the top along with the following categories.

Data Type – This is a drop-down menu of data types used to define the question. A Data Type can be a yes/no selection, a text box of single or multiple lines, or many other options that will be described in further detail below. Different form types may have different data values available for use. This list below is a comprehensive list of all data values available and are not all necessarily available within every form type. This category refers to the format and options the user will have to fill out. Once a data type is selected, a subsequent change may occur in the layout of the data details box, the page adjusting to take in the necessary information for that particular data type. A definition of each data value type can be found by selecting the Data Value Definitions link.

Note: Within this area the chosen Data Type will adjust the available fields; some will automatically fill, disappear, or new information will appear based on what is needed for that particular Data Type. This automated process is determined by predefined fields, which are saved in the system software. An example of this would be selecting a Merge Code from the list of Data Types such as Principal Investigator, or Study Title, where the information is automatically inserted from the information already loaded in the system. If this occurs, and the options on this page change, the page is refreshing to display the necessary information related to the selected Data Type. The main options listed for this page are described below, specific configurations for data types can be found with that data type in the Data Value Definitions portion of this manual.

Database Column Name – When you add a Data Value to the form, it is stored in the form table using this field as the column name. The database column name is also used when building branching and validation rules, which we will see later in this manual when covering building branching and validation. The database column name is used as the reference point, so be sure to label it with an accurate description. It must be unique, and no spaces or special characters are allowed in this category, but underscores “_” can be used for multiple word descriptions. It is a required field and may be pre-defined depending on the data type selected.

Note: When you setup a data value and save it, there is a flag in the system that will force the column name to be changed if a different data type is selected. This is done to prevent incosistencies in the database and the form when the data type is changed.  

Value Required – This required field controls whether the user is required to enter information in the field before proceeding to the next portion of a form or saving it entirely. The default setting is set to “No”. This field may not be available depending on the data type selected. If it is used and is set to “Yes”, an error message (see below) will be displayed when the user skips this question.

Order in Question – Reflects the order in which the data value will appear to users, within the question. It is a required field with the initial value set to 1. This section is important when there is more than one data value in a question.

User Defined Error Message – The text entered here will override the data required error message. The error message will only be displayed in the event that a value is required, and the user has failed to input data, and then proceeded to click the save and continue button.

Show Data value in table (Yes/No) – Determines whether the answer to this question will be shown in the database table for this form (i.e. from Study Management when viewing the record of this form after it has been created, as seen in the image below). In the screenshot below, the WEATHER column is shown because this field was set to “Yes” for the WEATHER data type, and the answer is displayed.

Note: This option is highly recommended for Yes/No data values or date fields; the size of the response in character width will result in making the list screen for the corresponding page to increase in width. This option is not recommended to be used with text string or table data values.

Data Dictionary Definition – The label for the new merge code associated with this question.

Unique Code used for data merge – Reference code that you use to link the data entered in this data type to other areas of the software, such as letter templates and notifications. If you are creating a unique code, it is a good idea to name the unique code the same as the column name for the data value.

Note: Data Dictionary Definition and Unique Code used for data merge work together. The Data Dictionary Definition is the label that will display in the list of available merge codes and the Unique Code will be inserted into the destination. Example, a merge code has been created for this form with the Data Dictionary Definition “Weather” and the Unique Code “WEATHER”.

This information can then be merged into certain system notifications, letters, agendas, and minutes (see screenshot below). When the notification, letter, agenda, or minutes document is generated, the system will display the appropriate study information when this code is used.

Is the value Read Only? – This field will allow you to set any Data Value to read only, which will gray out any areas that would have allowed the user to edit upon creation of the form. This value specifically works with the “Existing Form Variable” Data Type, which allows you to pull information from another form into the current form. Setting the value to read only will display the information in the form without allowing the user to modify it.

Element Info – The text entered here will be inserted above the data value and can be used as an instruction area for the user, as seen in the image below.

Visibility Dependency - The drop-down list is used to designate if this data value should be included in a Show Visibility rule. This will not be used when initially creating a form. Once you have the form sections, questions, and data values defined you can add the form logic.

Save Data Value– To complete the creation of a question in your form, fill out all of the required fields (marked with a red *), complete any additional fields of the data value details and click the Save Data Value button. Once the value is saved, you will receive a message confirming the save.

You can navigate back to Question Data Values by clicking on the Cancel – Return to List. The data value you created will be listed on this page.

To delete an existing data value, click the icon in the Remove Data Value column. The system will ask for confirmation before deleting the data value and all its contents from the form.

Add Help Links

The forms designer tool allows the user to add help links for each question in a form. Multiple help links can be added to each question. The help links cannot be viewed when clicking the View Form button in the form definition section. To view them, the form must be published, and viewed from a study record.

Click the Add Question Help Link button to add a new help link.

Help Order - Location in the question help column that the help file will be listed. Help Ordering defaults by 10s. Example, in a new form, the first Help Tip created within a question created will have the Help Order of 10. The next tip created will have Help Order 20, and so on.

Help Tip – This required field is used as a reference name that appears after you save your help link. It will also display in form view as you hover your mouse over the help link, as seen in the image below.

Select the Type of Help for this question – This is the actual information that will display when a user clicks on the help link and is a required field. There are two options available:

1. External Help link identified by a URL– The entire URL (Uniform Resource Locator or World Wide Web address) must be entered.
2. Formatted Help Text - Copy and paste text from another word processing application or enter in the text using the built in iRIS text editor.  This section will only allow text formats (No graphs, screenshots, pictures, etc.).

After entering the necessary data, select the Save button.  A message will be displayed to confirm the addition. You can navigate back to Question Data Values by clicking on the Cancel – Return to List. The help tip you created will be listed on the Question Help Links tab.

To delete an existing help tip, click the icon in the Remove Help Tip column. The system will ask for confirmation before deleting the help tip from the form.

Add Exclusion Filter

Exclusion Filters can be applied to certain sections and questions within a submission form, excluding access to that section or question based on review board. This feature is only applicable with multi-module instances of iRIS that share the same submission forms.

There are two areas where the exclusion filter can be set, within Edit Section-> Section Exclude from Review Board and Edit Question -> Question Exclude from Review Board. Setup for each area is the same.

Select the Add Exclusion Filter button to select from a list of Review Boards to exclude from this section or question. Only one selection can be made at a time.

Select the Save button after a selection is made. The selected item will appear under the Define Filter to remove access for Review Board area. Additional exclusions can be added by repeating the steps above. A selection can be edited by selecting the edit icon next to the appropriate Review Board, as seen in the image below.

To delete an existing help tip, click the icon in the Remove Exclusion column. The system will ask for confirmation before deleting the exclusion filter from the form.

Setting Form Access

Once the content of the form is in place, with sections, questions, data values, help tips and if necessary, exclusion filters defined, you can make the form active and available to users. Follow the steps outlined here to set the proper access.

1 – System Access

When configuring a form within the System Forms Designer, you will need to set the system access (where in the system you want the form available) within the Edit/Save Form details area.

 

This section gives you the ability to allow/restrict Review Board(s) and Study Management access to this form. Initially, none of the checkboxes next to the Review Boards/Study Management will be checked. This means that neither Review Boards nor Study Management will have any kind of access to this form, and this area must be set before the form is made available to users (even if the form has been published).  

Select a checkbox next to the appropriate Review Board(s) and/or Study Management. There are two types of accesses from which to choose:

1. Create Form Access – This will allow the selected Board or Study Management the ability to create the form.
2. Allow View Access – This will give the selected Board or Study Management the ability to view the form, but not the ability to create it.

Also note that if Create Form Access is selected, it will give view access automatically; therefore, only one box needs to be checked for an item.

Be sure to save this information.

Note: Additional details on this page will be covered in the Edit Form Details section of this manual.

2 – Publish the Form

You will find the Publish Form button within the main Section List area, as shown in the screenshot below.

 

Note: This selection will change to read New Form Version once a form has been published, any future changes can be recorded in a new separate version of the form and saving the history of each version in the system.

3 – Study Access

To find this area, navigate Home > System Administration > List Configuration & Maintenance > under the Status Roles area you will find the Define Study Assistant Role Access link. The screen will display the system & study role access table (the Forms Designer items can be found at the bottom of the screen).

Assign Read/Write access as needed for the study roles within your system and be sure to save the information.

*Note: If you are creating a Study Submission Form, after step 3 is complete, you should not be able to access the form from the Study Management area of a study (as long as your role on the study has the access set in step 3 as described above.)

4 – Review Board Access

To find this area, navigate Home > Select the Review Board Assistant you assigned access to in step 1. > Select the Review Board Administration > Select the Setup Role Access link. The screen will display the Review Board role access table (the Forms Designer items can be found at the bottom of the screen).

 

Assign Read/Write access as needed and be sure to save the information (if Read access was the only selection made available in step 1, it will be the only selection on this screen).

5 – System Workflow

Workflow will direct the form once it has been submitted to the appropriate review board. Once access has been set for the form, the workflow must be defined for Submission Forms. You can directly access the submission form current workflow by clicking the Go to Workflow Template button.

If the form does not have a workflow defined, clicking the button will prompt the creation of the workflow.

Note: This button is only available to forms defined in the system that are Submission Forms.

For more information about workflow, see the Sys Admin – Workflow Designer manual.

Form Branching

Form Branching is described earlier in this document and is used to direct a user completing a form down a certain path based on answers to specific questions. Branching can be setup before a user starts a form, so that the user is directed to a certain section in the form when it is initially created. It can also be setup within the form, so that as the user saves through the sections, the branching determines which section to display to the user.

Branching allows you to build rules which direct users down a specific path of a form (section by section), based on the answers already given.

Note: For additional information regarding the concept of Branching, select the link The Concept of Forms.

Section Branching

If you choose to create a form that has the “wizard enabled” (specific to submission forms only), you have the ability to set up the form using branching logic based upon a user’s response to certain questions. Branching allows the application to “branch” down certain routes according to a user’s answers to a specific question. Therefore, if a “Yes” answer to a question warrants additional questions, branching logic will identify this and change the route of the form accordingly.  

Branching can be flagged for a single answer to a question or a combination of answers within multiple sections.  The branching occurs from one section to another when the section is saved. The system would NOT be capable of branching from Question 1 (section 1) 🡪 Question 3 (section 1). If you are looking for functionality within the same section, refer to the Show Visibility section of this document.

The Section Branching page will list any branching rules setup within the section.

Select the Add Branch button to add a branch to the section.

The Add Section Branch window will be displayed, as seen in the image above.

Name Tag for this Branch – This is a display name used solely for the administrator when creating branches in a section. The tags are used to easily identify the branch and appear in the list of Branch Rules for the Section.

Order – This is used to order the branching rules. When branching is applied in a section it will run in sequential order.  This has the same concept as the Section Orders, Question Orders, and Data Value Orders.

Select the Section to Branch – The form will continue to the section selected here if the validations created in the rules (described below) are true. Otherwise, the form will continue to the next ordered section.

Comments – The comments are used internally to add any specific notes related to the Branch rule. Comments also display in the list of Branch Rules for the Section.

At the bottom of the window you can setup a rule that will look at a value in the form. The rule in the example below is setup to look at the Single Selection value for a question within the section. iRIS will take note if the value is answered “Yes” when the form section is saved. If the user indicates the weather is “Rainy” the system will branch to the section specified in the Select the Section to Branch drop down list.

For a complete list of the fields within the Branch Rule table, see Appendix A.

The Branching defined within the form can be reordered using the Order column. The order can be changed by typing in the new order then clicking on the Save Branch Order button.

 

Branching within the form can be copied to another section within the form. Within Section Questions -> Question Branching, click the Copy Branch button.

 

A window will open within the browser containing a list of branch rules to copy and a drop down selection of destination sections, including the current section. Select the destination section from the dropdown list, then check the box in the Select to Copy column. At the bottom of the window, click the Save the Branch Copy button to copy the branch to the destination section. Click the Cancel button to return to Section Branching without copying branching.

Branching into Form

This area contains Pre-Form Branching options that can set the user to branch to a specific section of the form as soon as the form is created, based on study attributes or review board selections. For example, if you would like a user to be “skipped” past some of the first sections of a form if the study used a specific application, you can set this area to “drop” them into the form based on configured rules.

 

The Branching into Form Logic button – Just as branching can be set up within each section, this button is used for what is termed “pre-form branching”. It allows a user to setup branching that will be enacted when end-users first add the form. The branching here can only be based on Study Attributes or Review Board Selections.

To Setup a rule, select the Add Branch into Form button. From here the Name can be entered, the order you want the system to view the rule(s) if multiple is being created, the section you want the user first branched to.

Once this information has been setup, you can select Add a new Rule, as seen in the image above, and build rules as needed (For a complete list of the fields within the Branch Rule table, see Appendix A.).

View Branching

Within the View Branching area, you can view a high-level summary of the current branching for the form. This feature is helpful to see a high-level view of the section-by-section branching set up for this form.

Each branch rule created in the form will list in this page by section.

 

 

 

 

The details of the Branch can be viewed by clicking on the icon in the Expand Details column. You can use the Print Friendly feature to print all the branch rules in expanded form.

Show Visibility

Visibility Rules allow you to setup rules to display questions and data values only if a question is answered a certain way in the current form section. The rules are setup in a similar way to Branching and Validation.

The rules are created and associated to Questions or Data Values so that information will only display if the answer to a certain question is “Yes”. The screenshot below has a Visibility rule setup and applied to a question within the section. This rule tells the system to only display the information if the answer to the Yes/No selection question is “Yes”.

If the value used is not selected or “No”, the information will not display in the form.

Visibility Rules can be configured to display or hide data values within a question, an entire question, or multiple questions within the section.

There are two parts to properly setting up the Visibility Rules.

Part One – Creating the Visibility Rule

Within Edit Section, navigate to the Section Show Visibility area. This will open a new page that will list current rules associated with this section. If no rules have yet been defined, the list will display no results.

To create a new Visibility Rule, click the Add Show Visibility button.

A window within the browser will open allowing you to create the rule. Enter the Name Tag, Order Number, and Comments.

At the bottom of the page you can setup a rule that will look at a value in the form. The rule in the example below is setup to look at the Yes/No value for a question within the section. iRIS will take note if the value is answered “Yes”.

For a complete list of the fields within the Show Visibility Rule table, see Appendix A.

Part Two – Associating the Visibility Rule to a Question or Data Value

Once the rule is defined, you can associate that rule to a question or a data value within the section. The rule will only be selectable within the section you created the rule for, it cannot carry over to other sections within your form.

If you need to associate the rule to a specific question, select the rule from drop down list that is available within Question Definition (shown below).

If you need to associate the rule to a specific data value within a question, select the rule from drop down list that is available within Data Value Details (shown below).

You would associate the rule to the Question or Data Value within a question that has the information you want to hide until the question is answered appropriately. You can associate the rule to multiple questions and data values, so if you have several items that need to remain hidden until the question is answered you can do that. Simply associate the rule to the appropriate questions or data values.

Please Note: Questions are set up by sections, so if the sections do not appear in order after answering a certain way, they are not deleted but are hidden. In the example below, since “Make ice lemonade” was chosen, the next question that appeared was “Where do you live?”. However, when Go the Beach was chosen, the question “Do you live near a beach?” showed up. Sections will be in order following the logic set behind the form.

 

Form Validation

Validation allows you to conditionally require values based on the answers to previous values in the form. The image below shows that the text field is required, but only because the first data value in the question was answered “Yes”. If this was answered “No”, the value below it would not be required. These types of rules need to be built into the form as Validation.

Note: For additional information regarding the concept of Validation, select the link The Concept of Forms.

 

Validators can be added by accessing the Section Validation page within Edit Section.

Select the Add Validation button to add a validation to the section.

The Add Section Validation window will be displayed, as seen in the image above.

Name Tag for this Validator – This is the display name used solely for the administrator when creating validations in a section. The tags are used to identify the validation and appear in the Sections outline.

Order – Used to order the validation rules. When validation is applied in a section, it will run in sequential order. This is the same concept as the Section Orders, Question Orders, and Data Value Orders.

Enter the Validator Message – This is the error message that will be displayed within the form if the validation rule triggers.

If you want the error message to be associated with a designated data value, Please make the association – You can specify which value in the section you want the error message to display next to. The drop-down list will contain the database column names for the data values within this section. If you associate the message to a value, the error message will display similar to the example above, displaying below the selected value.

Comments – The comments are used internally to add any specific notes related to the Branch rule. Comments also display in the list of Branch Rules for the Section.

At the bottom of the page you can setup a rule that will look at a value in the form. The rule in the example below is setup to look at the Yes/No value for a question within the section and also if the value below is empty. When the user completing the form saves the section, this rule would run and give the message provided if the answer to the question is “Yes” and the value below it was not answered.

For a complete list of the fields within the Validation Rule table, see Appendix A.

Miscellaneous Form Items

Form Categories

This area (from the drop-down menu as seen in the image below), allows you to group and categorize Study Submission Forms as you would like them to display to your users within the Study Management area of Study Assistant.

 

Selecting the Define Project Form Categories will bring you to the page where these categories can be added. Later in the manual we will see where forms can be associated to these groups and categories within the Form Setup Details area of the form itself.

Note: Below you can see that there are 2 hard coded categories, Project Items and Protocol Items; do NOT edit these items or your Study Management page will not display to users.

Selecting to Add a New Category prompts you to enter the required Category Name and Category Order you want it displayed in, as well as the Category Group Color. After you have saved the information, an additional Add a New Group button will display, as seen in the image below.

Associating a Group is optional but can assist with further grouping of your forms.

Once forms have been associated to Categories and Groups (described later in the manual) they will display in their specified area just like the pre-canned protocol items you may have already seen in the Study Management area, as seen in the image below.

You can also associate a form to a category and group within Edit/Save Form Details.

Export / Import Forms

Exporting/Importing forms is a useful process to follow to keep a backup of your current forms. Export a form before major modifications in case you need to roll back to the previous version. Exporting/Importing forms is also used between a Test instance of iRIS and Production instance. Any form changes are first made and validated in the Test instance, then exported from Test and imported into Production. This way all changes are validated prior to publishing the changes in a Production environment.

Export Form

Navigate to the Section List for the form you would like to export. The Export Form to XML button will allow you to export your form (as it currently is at time of export) and creates an XML file of your form to save to your computer.

 

After selecting the Export Form to XML button, a message will be displayed to confirm the download. Select OK to continue or Cancel to cancel.

After selecting the OK button, a dialog box will be displayed to ask if you would like to open or save the form.

Note: These files are solely used to work in the System Form Designer (for importing at a later time) and will be displayed in XML code when opened.

You will be prompted to save the file to your computer. When presented with the option, choose to Save the file, and choose the location.

A download completion dialog box will be displayed after the download is finished.

Note: The dialog boxes prompting to save the file may appear different than what is shown in this manual, depending on the browser being used to download the file.

Import Form

The Import Form option can be found within the Operations drop-down on the top right-hand corner of the system form designer main page. This button will allow you to import forms from your computer into iRIS. The file you choose to upload should only be a file that was exported from iRIS, any other file will not import properly.

 

After selecting the Import Form button select the Upload the form definition file button, as seen in the image above. This will direct you to an Upload Document browser pop-up screen.

Select the Browse button to browse the documents on your computer. A window dialog box will be displayed for you to select from files and folders on your computer. After you have made the selection, click the Open button. The location of the document selected will appear in the Document Location field. Select Save selected file to upload the document or Cancel to cancel the import.

After the document has been uploaded, the document’s information (Form Name, Form Database Table Name, Form Type, and Form Version) will appear under the Upload the form definitions file button. Select the Save the Imported Form button to save the form. The form will now appear in the form list in Update status.

Note: If the form Database Table Name matches a form in the system it will override the current version of the form with the same Database Table name.

Delete Form

 

The Delete Form option can be found within the Operations dropdown on the top right-hand corner of the System Form Designer main page. As seen in the image below, to delete a submission form from the system, select the Checkbox next to the appropriate form and click the Delete Form button.

Note: This will also delete the workflow corresponding to this form in the Workflow Designer. Please see the System Workflow Designer Manual for additional information.

**NOTE: iMedRIS does not recommend deleting a form that is in use by research studies or projects. If a form is deleted from the Forms Designer, any study or project associated with that form will lose the data associated because the form no longer exists in the system. 

If you wish to discontinue use of a form, the form can be turned off in Edit Form Details (which is described in more detail in the following sections).

 

Publish Form

This tool gives you the control to create new versions and publish versions of a form when your form changes are complete and ready to use. Selecting to Publish Version, will publish any changes made to the form, and cause this button to change to display New Form Version. Once you publish the form, your changes to the form are available to anyone filling out the form. When you create a new version, you create an editable version of the previously published form.

Once a New Version has been created, the form is considered in “Update” status and changes can be made to the form as needed. However, a published form is considered in “Active” status and is locked down and only a few of the configurations are available to change.

In order to allow the users to have access to a form, the form must be published at least once in the system. This action creates a mold of the form which users have access to. Until a form has been initially published, users will not have access to it. You can publish a form by returning to the Section List page and clicking on the Publish Form button.  

Note: The first time a form is being published additional steps need to be taken to allow access to the form. These steps are detailed in the Setting Form Access section. The main forms designer page has two areas that are affected when a new version of a form has been created. First, the Show History folder will be available; opening the folder will expand the previous versions of the form, as seen in the image below. These versions can be viewed however they cannot be edited, published, or pushed ahead of the current form version.

The second area is the Form Status column, this column displays “Active” if a form has been published, and “Update” if a New Version has been created, which means that the current version of the form is in an editable state.

Notes:

When a new version of a form is published, users will be prompted to convert to the new form version when they access an incomplete form. If the form has been completed and submitted, there will be no need to convert, and the user will not be prompted to convert. The screen below displays the prompt a user will receive when the form they are currently working on has had a new version of the form published.

When the form is converted to the new version, the form will retain data within the form for all unchanged data points.  More information on this will be available in the next section.

Form Details

This section allows you to define certain form configurations and set access to individual Review Board(s) and/or Study Management. It is essential that this area be set up before attempting to use the form. Note: Different form types have different options included in the Edit Form Details page.

When you modify settings on this page, be sure to click the Save Form Setup Details button before navigating away.

Form Type – This will display the type of form chosen when the form was created.

Form Name – This will display the name of the form, which can be changed.

Form Abbreviation – If the Use Numbering (described below) property is set to “Yes”, the Form Abbreviation will be displayed in the form’s list on the study or project, along with the version number of the form. In the example below, the Form Number column displays “WF-1.0”. “WF” is the value entered in the Form Abbreviation field and “1” is indicates the number form for the study (this is the first form created for the study, therefore, it displays “1”) and “.0” is the number of revisions this form has undergone.

This abbreviation also affects the reference number when the property for a “formatted submission reference number” has been turned on. Previously, all submissions received a reference number automatically by the system. Now, a new property has been added under System Administration > Study Configuration > Study Default Settings, labeled system.use_formatted_submission_reference_number that will allow an institution to set a format for their reference number that includes the form abbreviation and version number, RB_NUMBER-Form Abv-Version.Revision.  

Form Order Number – The default form order number will initially be “1”. Form Order Number displays the location of this particular form in the Study Management Submissions tab. Forms are arranged according to their numerical value. In the example below, Weather Form has been given the Form Order Number “1” and displays at the top of the list. The other forms listed have been ordered “2”, “3”, “4”, etc.

Navigation Name – This name will be displayed in the navigation panel when the form is being filled out. This value is defined when the form is initially created and can be modified here.

Restrict form to allow only one to be under review at a time – When set to “Yes”, only one of this specific form will be able to be submitted for review at a time. For example, if the study side submits an Amendment form to amend an aspect of the research, the study side cannot submit another Amendment form to amend the KSP.

Use Routing Signoff Sheet – Setting this to “Yes” will enable the user submitting the form to route for additional signoffs before submitting the form into the workflow.  

Control Locking of the Form through Workflow – When set to "Yes", the "Lock Submission" node will be available in the Workflow graph for this form. This will allow you to keep forms editable after they are submitted in the workflow until they reach the step “Lock Submission”.

Who is required to Signoff Initially – This dropdown list allows you to indicate whether the Principal Investigator is required to sign off on this submission form, or if any personnel on the study, who has submission rights, can signoff and submit the form.

Select the Category Name? – Allows you to set the Category that you want this specific form to display in for users in the Study Management area of Study Assistant. (This is a configurable list, which can be edited from the main System Forms Designer page > Setup Form Tools > Define Project Form Categories. Also, described earlier in this manual).

Select the Category Group Name? – Allows you to set the Group that you want this specific form to display in for users in the Study Management area of Study Assistant. (This is a configurable list, which can be edited from the main System Forms Designer page > Setup Form Tools > Define Project Form Categories. Also, described earlier in this manual).

Form Order in the Group -In addition to the Form Order Number, you can use this tool to reorder the forms within the specified group.

Form will only be displayed with selected Application – This setting will allow you to associate the form to only display in the Study Management area for studies which have created a specific Application. (Example: IRB Continuing Review Form set to only display when the IRB Application was created).

To setup this functionality, select “Yes” then click the Associate Form with Application(s) button. A window will open within the browser that lists the Study Interview forms defined in your system. Select which application to associate to your form, then click the Save button. Click the Cancel button to return to the Edit/Save Form details page without associating an application to your form.

Paging Increment – This determines how many forms will be listed per page in this form’s list on the study. If there are more forms in the list than the number in this field, the list will continue to the next page.

Use Section Numbering – Setting this to “No”, will remove the auto numbering system that generates as a form is being created (i.e. section 1.0, 2.0, 3.0, etc.). The images below display the forms section header and questions, when set to “No”, and when set to “Yes”.

Use Name Created – The user who started the submission form will be displayed in this submission form’s list. If this is set to “No”, the Created By column will not be displayed in this submission form’s list.

Use Date Created – The initial date this submission form was created will be displayed in this submission form’s list. If this is set to “No”, the Date Created column will not be displayed in this submission form’s list.

Use Name Modified – The latest user who modified the submission form will be displayed in this submission form’s list. If this is set to “No”, the Modified By column will not be displayed in this submission form’s list.

Use Date Modified – The latest date this submission form was modified will be displayed in this submission form’s list. If this is set to “No”, the Date Modified column will not be displayed in this submission form’s list.

Use Reference Number – A reference number will be generated for each submission form created regardless of this property’s setting. If this is set to “No”, the Ref Number column will not be displayed in this submission form’s list, but if it is set to “Yes”, then the Ref. number column will be displayed in this form’s list in its own column.

Use Notification on Waiting Submission – When set to “Yes”, this will cause a notification (setup in List Configuration and Maintenance) to be sent to the Study Contact when this form has been completed and is waiting for submission.  

Use Follow-up Form – This feature allows you to associate one form with another. This tool is intended for Adverse Event Forms, once configured and the use of the Adverse Event form data value. It allows you to select an Initial Adverse Event forms to associate to your follow-up adverse event form. The functionality here is intended to allow the study team to provide an update. Once you associate the previous form, it actually pre-populates your current form with the old values to allow you to quickly update the new form. See the Study Assistant – Study Submissions manual for more information on using this functionality.

Trigger Action Plan in Submission Outcome – When set to “Yes”, a new tab will appear when processing the submission.

Use Wizard - Allows the form creator to construct a form using branching logic. This is a feature of the software that gives you the ability to branch not only in an application, but also in any submission form that is sent to the Review Board. This is first selected after you have chosen a form type while adding a new form and it can be modified here.

Display Form Option for New Studies – This property allows you to make a form available when studies are first being created. This property should always be set to “Yes” for application forms, unless you do not want the application form available to users.

Validate by Section – Setting this to “Yes” will create a validation checkpoint whenever the Save and Continue to the next Section button is clicked. The validation will check whether all required fields are filled out. In most cases this should always be set to “Yes”.

Use Numbering – This will display the form abbreviation as set in the Form Abbreviation field (described above, at the top of this list) in this form’s list along with the version/revision number.

Does Receipt Satisfy Continuing Review Notification – When set to “Yes”, the receipt of this form by the review board will satisfy as the studies continuing review notification.  

Does Receipt Satisfy Full Renewal Notification – when set to “Yes”, the receipt of this form by the review board will satisfy the as the full renewal notification.

Lock Study Access to Board Access – When this property is set to “Yes”, this form will not be visible to the study until the review board set within Associate Access (described below) has reviewed the study.

Prompt for Subject – When this is set to “Yes”, adding a new form will default to this screen, first prompting the user to associate a subject with this form. This field is only applicable to systems that use the Subject Management module.

Associate multiple Studies – When this is set to “Yes” there is the option for the user to copy a form already added within a study to another study record.

When a user clicks the icon in the Apply to Multiple column, a list of studies the user is associated to will open. Select the studies to apply the form to, then click the Save a Copy of the selected form button. The system will create a new form record for each study chosen. Each new form will need to be submitted individually from each study.

Define Menus by form rules not branching - & - Assign Sections for selection of Users to Complete – Setting both of these areas to “Yes” a user can assign certain parts of the form to different personnel on the study.

This must be done by setting the Validate By Section property to “No”, the Define Menus by Form Rules not Branching to “Yes”, and Assign Selection of Users to Complete to “Yes” in the Edit Form Details screen of the Study Application form. When this is done, the Menu Logic can be setup by clicking the Auto Expand Menu button that can now be found within the main navigation within the form.

Setting up logic here is similar to setting up validations. The logic specifies a certain rule that must be satisfied (like a validation). The user also sets up the section that will be available for assignment once the rule is satisfied. Once the menu logic is set, when adding a new study and filling out the application past the first three study shell screens (Sections 1.0, 2.0 & 3.0), the menu logic will be activated and the Assign User(s) to Sections button will appear.  

Clicking this button will display a list of the screens defined in the menu logic to have specific users assigned to complete them depending on whether each rule set up for the section assignment is satisfied. When these screens are assigned to certain users, they will be visible to other users in the study, but just as a read only screen.

Update LAST Approved Application and create a new revision with data form values that are designated to sync with the Application from this form - You can configure Amendment submission forms to automatically update the Application form of a study when changes affect the content of the Application. This allows the Application to remain current as amendments are approved, without having to manually create revisions of the application, as long as the steps listed below are setup and configured.

Board coordinators and board members who are reviewing the Amendments will have the option to see the changes directly within the form itself, as opposed to having to review both the Amendment form and the revised Application.

After you have created the association between the Submission form and the Application within the System Form Designer, data is pulled from the Last Approved Application on a study and populated when an Amendment or Modification Form is being generated on that study. The system will automatically create a revision of the LAST approved Application along with the updated and approved amendments.

The “Existing Form Variable” data value will allow you to pull information from one form to another. Once this value is selected, you can choose the Application to pull data from and then map the Data Value. To the right of the data value association, set the flag to “Yes”, for the label Sync the value with the LAST Approved Application version when this submission is Approved.

Steps in this process include:

• Form Designer – Create and Define a Study Application Form
• Form Designer – Create a Submission Form with “Existing Form Variable” Data Values pulled from the Application.
• Indicate that the value is to be synced with the Application in the “Select the Form to pull the value from” area.
• Select the Data value that is to sync in the “Select the Data Value from the selected form” area.
• Select “Yes” for the “Sync the value with the Last Approved Application version” on the right.

These steps will allow you to create values that pull from the last approved application to the Amendment form.

Application Sub Type (only in Study Application Forms) – This section allows the user to distinguish between different boards with a numbering structure. Note: the ‘Research Application’ type is a special application type not associated to a specific board. When the Application Type selected is ‘Research Application’ the system will NOT generate a study number.

This functionality is dependent on the property: system.add_irb_number_on_study_create being set to “Yes”.

Form Description – This section allows the user to write a description about the form with unlimited number of characters.

Associate Access for Form – This section gives you the ability to allow/restrict Review Board(s) and Study Management access to this form. Initially, none of the checkboxes next to the Review Boards/Study Management will be checked. This means that neither Review Boards nor Study Management will have any kind of access to this form, and this area must be set before the form is made available to users (even if the form has been published).  

Select a checkbox next to the appropriate Review Board(s) and/or Study Management. There are two types of accesses from which to choose:

3. Create Form Access – This will allow the selected Board or Study Management the ability to create the form.
4. Allow View Access – This will give the selected Board or Study Management the ability to view the form, but not the ability to create it.

Also note that if Create Form Access is selected, it will give view access automatically; therefore, only one box needs to be checked for an item.

Section, Question & Data Info Font – At the very bottom of the Edit/Save Form Details page are three options that allow users to customize the font and font size for all sections, all questions, or all element info at once.  

Note: If you use any color in your sections, questions, or data value element information using this option will cause all font colors to restore to black. It is recommended to wait until all your font sizes and types are set using this tool before changing font colors.

Save Form Details – Once all selections are made and the Edit/Save Form Details have been customized, click the Save Form Setup Details near the top right corner of the page.

Form Tool Tips

This area allows you to create a help popup for specific words within form questions. By hovering over the text with the mouse cursor, the tool tip text you have defined will display. This feature is helpful for a regulatory change or a complicated area where providing additional explanations will be beneficial.

Please Note: This feature hyperlinks all word or words that it matches throughout the form, not just the first time it finds that text.

Selecting the Add Tooltip button allows you to enter the Keyword and the Keyword Tool Tip that you would like available to users, as seen in the image below. After the information is entered, click Save.

The tooltip defined will apply to all words/phrases defined in the Keyword field within the Questions defined in the form, as shown in the image below. When the keyword is activated, the tool tip text will display to the user.

Fillable PDF Document Print Options

This button allows the user to define a PDF document for a Form. The PDF will act as a template for the system form. The template will be populated with corresponding system form data when viewed by the user. This tool gives the user the ability to upload and populate PDF forms of their own design. You must create a fill-able PDF in Adobe Designer first. After it has been uploaded, you can map fields by inserting specific merge codes from the iRIS form into the fill-able fields.

Note: More detailed instructions on how to use this particular aspect of the software are given in the PDF Tool Manual.

View Form

This feature is used to view all sections and questions of your form on one page, as seen in the image below. The scroll bar can be used to move through the form. Please note that this area will only allow you to view the appearances of the form before it is published. Text editors, buttons, and calendars will not work here.

You can use the Print Friendly button to open the form in a printer friendly view.

Note: The predefined data types such as the IRB or Study fields will not have any data value listed in them. This is because this is only a “draft” of the form and does not pertain to any specific study.

If you have created branching rules and/or validations for your form, they will not be represented here. To view them in action you must first publish the form and then fill out the form in the appropriate section of the software.

Form Database Details

Within the Form Database Details area, you can expand the form table to view all data column names associated to the form.

Review Section

Additional sections can be built within a form that will be completed by a review board. When the review board accesses the form, an additional tab will populate called “Review Board Sections”. This will display the content of the review section.

This section can be setup by accessing the Add Review Section within the main Forms Designer page.

 

Choose which review board will complete the review section, then click the Save button.

A page will open, allowing you to define the contents of the review section. Building a review section is similar to building any other form type. You will add sections, questions, and data values and publish the form when you are ready to make it active.

Once a Review Section has been defined for a form, a folder will populate in the Show Review Sections column, as shown below. When you click on the folder, additional details will populate below the form. More than one Review Section can be defined for a form, but only one form per board can be defined.

 

Note: Any Review Board section defined will populate in all print views of the form, and within Entire View of the form, as seen below.

The Review Board Section will also display within Study Assistant for research personnel in read only format.

Routing Forms – Inclusion Rules

Within the Routing Form, in place of creating branching rules that will direct a user to specific sections based on answers within the form, you have the ability to define rules that will include the section on the signoff page.

Routing Forms are programmed to display within the routing signoff page for a submission form, so they do not use branching logic, instead, each section defined in the form will display on the same page, similar to the routing form displayed below.

You can create Include Rules to specify when a section defined in the Routing form should display on the routing signoff page. In the example below, an Include rule has been defined for the first section. The rule specifies that the section should only be displayed when the Application Type associated to the Study is the IRB Application.

To setup the rules, navigate to Section Include Rules within a Routing Form. This menu option is only available for Routing Form types.

Selecting the Add Section Include Rule button in this area will allow you to build rules for the inclusion of the section based on the Application Form, Review Board Selection, or the Application form type used on the Study. For more information on the rule definitions, see Appendix A.

Any section with an Include Rule defined will only display that section when the rules defined are met. If a section does not have any rules associated, then the section will display within the routing signoff page no matter what (for the role and form defined within the Routing Form Role Association, see the Submission Signoff Routing Forms section for more information).

Customized Study Shell

The first three sections in an application, also known as a “Study Shell”, are customizable. The defaulted questions in these sections can be edited by navigating to System Forms Designer > Edit > Edit Study Application Sec 1-3.

Once the “Edit Study Application Sec 1-3” is selected, the three sections, and all of the questions each section contains, are displayed. Each question in the section has an accompanying checkbox that is placed in the “Override Default” cell. When that checkbox is clicked, an “Edit Text” button is displayed in the cell for that question in the “Invoke Editor” column.

When the “Edit Text” button is clicked, an editor window is prompted.

After the desired text has been typed, the “Apply” button must be clicked in order for the typed text to be displayed in the “New Text” cell. Once all of the edits are made, the “Save Section Mappings” button must be clicked in order for the edited text to be displayed in the application.

Customized Study Shell KSP

 

There are four KSP properties within: System Administration > System Configuration > Study Application Setup. When these properties are set to “Yes”, the KSP options appear on the study application. When a KSP property is set to “No”, it will not appear on the application, nor will it appear in System Form Designer > Edit > “Edit Study Application Sec 1-3” side navigation tab > Section 3.0.

 

In the image above, the property which dictates the “Fellow” KSP to appear on the application is set to “No”. Therefore, there are only three KSP selections that can be modified within the study shell.

When the “Override Default” checkbox is selected, the “Edit Text” button will be displayed, allowing customization of text. Clicking on the “Override Default” box then clicking on the “Remove Question” box will remove the KSP selection from the application entirely.

In the image below, two KSP selections are displayed and the customized text is being used and displayed on the study application.

Helpful Tips

• It is highly recommended that you Export a form prior to making extensive form revisions. This way if you need to revert to a previous version you can import and restore the form.
• When changing existing values in a form, it is advisable that you create a new data value in place of the old or change the data column name.
• If rearranging a form that is being used in a production environment, keep in mind that users may convert to the new form version. If they do this, questions they already completed in the old version may be affected especially if those sections, questions, and data values are deleted and/or the data value column name is renamed/changed.
• Selecting Delete Form will delete the entire form, not just the current version. We recommend that if you made a mistake in creating a revision of a form and you need to go back to the previous version, import the previous version that you saved to your computer. Deleting a form will also drop the form from the system. iMedRIS does not recommend deleting a form in a production environment that users have filled out for research projects. If you delete the form, you will break the link between the study and the form, resulting in major data loss. Also, when a System Administrator deletes a form from System Form Designer, the form is now removed from the UI and it is not useable by any user. If the deleted form was already submitted, the form will still be displayed within the study’s submission history.
• iMedRIS recommends having your study application as close to complete as possible prior to Go Live. Form revisions in a production environment are possible, and most institutions revise forms every 6 months to a year. If you have not completed the major form revisions prior to Go Live, this will impact the users filling out the application, as they will be presented with the Convert to the New Form version when they open their current study application form. When they convert, they may experience data lose due to any major revisions (deleting sections, questions, data values, or renaming data value column names).

Appendix A – Branching/Visibility/Validation Rules

Order – This order field determines in which order the rules will be checked against the value entered by the user.

What to Validate column has a list of options from which to select from. Each option will adjust the options available in the Data Value column, as seen in the explanations below.

Applic. Form all columns – This selection will pull in the database column names from the specified Application Form in the “Data Value” drop down list. This is used when you want your rule to reflect a value completed in the Application Form for the study or project. The Data Value column will first ask “What Application?” you are setting this rule for. Once this is selected, the “Data Type” column will update and ask which application to pull data from, then it will update with the database column names from the selected application.

Current Form section columns – This is the default selection for this dropdown list. This selection makes all the database column names used within the current section available in the “Data Value” drop down list. Use this when you are going to be comparing data values from the current section only.

Current Form all columns – This selection makes all the database column names used within the form available in the “Data Value” drop down list. This is used when you want to create a rule that is based on the answer to a question from a previous section within the form.

Review board selection – This selection provides the ability to select a certain review board in your system. This is used when you want to create a rule based on the board of record for the study or project.

Application form type used on Project – This selection provides the ability to select a certain Application Form in your system. This is used when you want to create a rule based on the Application Form that is associated to the study or project.

Study attributes – This contains study attributes such as study classification, exempt, or sponsor.

The Data Value column populates based on what was selected in the “What to Validate” column. Keep in mind the Data Value is pulling the database column names that were created when the data value was created, as shown below.

Choose the Database Column Name from the Data Value drop down list that matches the data value you need to validate against.

Once you select a database column name from the “Data Value” drop down list, additional information will populate in this column. The information displayed will be dependent on the type of data value selected. The example above displays “Yes/No/Not Set” because the data type chosen is a “Yes/No” selection in the form. When you select a different data value, you may have a different option. The example below displays a free text field, because this chosen data type is a Single Line Text field.

After you select the database column name from the Data Value drop down list, you can specify what value will constitute triggering the rule. If the data type is a selection, specify “Yes”, “No”, or “Not Set” (this means the user did not provide any value, Yes or No). If the data type is a text field, you can type in the desired value or type “NULL” (this means the user did not provide a value for this data type).

Available Data Value Options:

Text field – A Text field will be available for any option that has been matched to a data value for a single line text field, multi-line text field, embedded text editor, or a document attachment. You can type in a value that must match for the rule to trigger or you can type in “NULL” to indicate that the value is empty.

Yes / No / Not Set – This value is present for “Yes/No” data values. Setting this to “Not Set” will indicate that the value is empty.

Drop Down list of Values – For any data value that maps to a dropdown list in the form, the selections within that drop-down list will be presented here, with an additional option “NULL”. You can choose the value that will trigger the rule or select “NULL” to indicate that the value is empty.

Drop Down list of Numbers – The data type “Multi-select” will present a list of numbers. The numbers listed in this drop-down list will reflect the number of options in the data value in the form. Example, if a data value in the form has 5 options, using that data value in the rule will provide a drop-down list with the numbers 1-5 for selection. You can select which value will trigger the rule. If more than one answer will trigger the rule, additional rules can be built using the same Data Value.

Setting the Validate Action – After selecting the Data Value, you can indicate how the data value relates to the rule. In this case, a “Yes/No” data value has been associated to the rule. The next step is to indicate whether the rule will trigger based on whether the answer is “Yes” or not “Yes”. The “What to Validate Action” provides options to indicate whether the value “Yes” should be selected or not. In most cases, the “EQUAL” action will adequately capture the rule, however in some cases the other options need to be selected.

EQUAL – This action is used to indicate that the value entered in the form for the specified Data Value must be equal to the selection. In the example above, the rule will only trigger if the value in the form for the “WEATHER_RAINY_COAT_YN” equals “Yes”.

NOT EQUAL – This action is used to indicate that the value entered in the form for the specified Data Value must not equal the selection. We could write the rule to be opposite, to say that the rule will only trigger if “WEATHER_RAINY_COAT_YN” is not “Yes”, which means anything but “Yes”, which means the value could be “No” or left blank and the rule would trigger.

LESS THAN, LESS THAN EQUAL, GREATER THAN, GREATER THAN EQUAL – These actions can only be used when the Data Value selected is a numeric value. If this is the case, you can build a rule that will only trigger if the specified value for the data value is less than, less than or equal to, greater than, or greater than or equal to the value specified in this rule.

Value –The last association to the selected data value that must be made is the Value drop down. The default selection is “Value”, which is typically the correct setting. This selection is the relation between the selected Action and the value of the Data Value selected. In the example below, the Data Value “WEATHER_RAINY_COAT_YN” must be “EQUAL” in “VALUE” to “Yes” in order for the rule to trigger. The other options are described below.

The only time you would select a different option other than “Value” is if your rule is checking to verify that the answer to this question in the form equals a value in the application or another area of this form.

Applic. Form all columns – This option allows you to check the answer to a data value in an Application form.

Current Form section columns – This option allows you to check the answer to a data value in the same section.

Current Form all columns - This option allows you to check the answer to a data value in the same form.

When any of these items are selected, an additional drop-down list will be available in the Data Type column.

When one of these options is selected, the additional details for the Data Value column are not needed. The rule will trigger if the first Data Value selection is equal to the second Data Value selection.

Join by, if any – This column will be used if your Branch, Show Visibility, or Validation determination is based on more than one value. Each rule will have a separate record here and each can be checked to determine if branching is required. When you have two rules, you will need to join the rules by making the appropriate selection from this drop-down list. If you only have one rule, this selection can remain set to “None”. If you have more than one rule, the last rule in the list must have this value remain “None”, as there are no rules to join to the last rule.

Note: Almost all Validation Rules are built using two clauses in the rule. The first clause will determine the value of the first question, and the second clause will validate whether the second question has been completed by the user. In the example above, the clause looks to see if the first question is answered “Yes”, the second clause looks to see if the second question is not completed by the user. These two clauses are joined by the “AND” joiner, meaning both clauses in the rule need to be true in order for the validation to trigger.

Basic Cases:

1. AND – This selection will require both clauses to be true before the criteria are met. If there are multiple clauses and they are all joined by the AND selection, then all clauses will have to be true before the criteria are met.
2. OR – This selection will only require one of the clauses to be true before the criteria are met. Even if there are multiple clauses joined by the OR selection, only one clause will need to be true.

In the more complicated cases, you would have to keep in mind what questions need to be grouped together. All the AND joiners will be grouped together, and the groups will be separated by the OR joiners.

Example:

Clause 1 AND Clause 2 OR Clause 3 AND Clause 4 – In this case, either clause 1 & 2 both have to be true, or both clause 3 & 4 have to be true for the overall validation to take effect.

 

Appendix B - Data Value Definitions

 

Data Values allow you to either create an area for the user to enter information or configure the system to pull study or project information into the form. Additionally, Data Values can be used to give users options to upload documents such as consent forms, and other study documents, and many more options.

The Data Type drop down is available within Edit Section -> Section Questions -> Edit Question -> Question Data Values.

When you select a data value from the Data Type drop down list, the page will update with specific Element Definition information based on the chosen data value.

Each data value available in the system is described below. Some data values are only available for specific form type and will be noted which form it is available in.

Study Submission Form Type – Data Values

This area covers the main data values within iRIS which are used in Study Submission Forms.

Primitive Data value fields

Text - Single line – This data value will provide a single line text field within the form. When this data value is selected, additional Element Definition will populate on the page, allowing you to specify an Initial Value (if any), the Character Width, and Maximum Characters. The default width and max are 60 and 80. Adjust the Character Width to increase or decrease the size of the text field. Adjust the Maximum Characters to allow more or less characters in the text field.

Text – Multiple line – This data value will provide a multi-line text field within the form. When this data value is selected, additional Element Definition will populate on the page, allowing you to specify an Initial Value (if any), the Character Width, Lines, and Maximum Input Length. Adjust the Character Width to increase or decrease the size of the text field. Adjust the Lines field to increase or decrease the number of lines available in the field. Adjust the Maximum Input Length to put a character restriction on the field, otherwise, there is no maximum restriction.

When the amount of text entered into the field exceeds the size of the text field, a scroll bar will be available to navigate through the text.

Text - Rich Text Editor – This data value will provide a multi-line text field within the form. When this data value is selected, you can specify if the editor is embedded into the form or will appear as a button within the form.

The Embedded default option is “No”. This means that the Rich Text Editor will appear as a button within the form, as shown below.

When the Rich Text Editor is opened, a window will display within the browser. From here, you can type in the text or copy and paste from another source. You can also use the tools available within the editor (spell check, alignment, formatting, etc.). When you are finished adding the text, click the Apply button.

 

The saved text will display within the form below the Rich Text Editor button, as shown below.

When the Embedded option is “Yes”, the editor will display embedded within the form, as shown below. You can type in the text or copy and paste from another source. You can also use the tools available within the editor (spell check, alignment, formatting, etc.). The data will save when you save the form section.

 

Selection –Yes/No – This data value will provide a Yes/No selection within the form. When this data value is selected, additional Element Definition will populate on the page, allowing you to specify an Initial Value (if any). You can also choose whether or not to allow the user to clear their selection by indicating “Yes” or “No” to the Does this value allow to clear the selection option.

Selection - Agree/Disagree – This data value will provide an Agree/Disagree selection within the form. When this data value is selected, additional Element Definition will populate on the page, allowing you to specify an Initial Value (if any).

Selection - Single – This field allows you to define a single selection list within the form. When this data value is selected, the Element Definition area will update allowing you to define the details of the selection. Start by indicating the number of selections in the How many selections do you have field. The default value is 10. You can have as few as 1 selection, up to 999 selections. If you change the default number, click the Save Data Value button so the system will refresh and display only the specified number of fields on the page.

Next, define the Value and Caption for each item to include in your selection list. You can set an Initial State (if any) and allow the user to clear the selection.

The Value field is used to identify the selection in the database, so in places like the Validation and Branching rules, you will see the Value field for the Single Selection.

The Caption field is what will display within the form, as shown below.

Selection - Multiple – This field allows you to define a multiple selection list within the form. When this data value is selected, the Element Definition area will update allowing you to define the details of the selection. Start by indicating the number of selections in the How many selection(s) do you have field. The default value is 15. You can have as few as 1 selection, up to 999 selections. If you change the default number, click the Save Data Value button so the system will refresh and display only the specified number of fields on the page.

Next, define the Caption for each item to include in your selection list. You also can set an Initial State (if any).

How to use the In Use and Order fields:

Each selection option has an In Use and Order field associated. By default, the In Use field is selected and the Order is in numerical order from 1, to the end number of selections used for this data value.

These fields are available to allow you to change this data value after it has been defined and used in the form. If, after a time, one of the options in the multiple selection no longer needs to be used, instead of having to recreate the entire data value, or rearrange the selections, you can specify that the option is no longer in use, as shown below.

An option that is flagged as no longer In Use, will not display in the published form:

If the options within the multiple selection need to be ordered differently, instead of redesigning the entire data value, you can reorder the selections using the Order field.

The options within this data value will appear in the Order specified within the published form:

Using the In Use option allows you to protect any Branching, Show Visibility, or Validation rules you may have defined and associated to the multiple selection data value. When you define a rule, the values in the Data Value drop down list directly related to the options, in order as they appear in the Data Value setup page.

Example: Option A = “1” in the Rule setup. Option B = “2”, Option C = “3”. If Option B is decided no longer needed within a form, and you rearranged the data value to only have 2 selections, Option A and Option C they would then become “1” and “2” respectively, in the rule setup area. If you have a rule that was programmed to look at Option C for branching and validation, the rule would still be pointed to “3”.

However, if, instead of rearranging the data value, you chose to specify that Option B is not In Use, the associated rules would continue to look at Option C as “3”.

Selection - Combo box – This field allows you to define a dropdown list within the form. When this data value is selected, the Element Definition area will update allowing you to define the details of the selection. Start by indicating the number of selections in the How many selection(s) do you have field. The default value is 10. You can have as few as 1 selection, up to 999 selections. If you change the default number, click the Save Data Value button so the system will refresh and display only the specified number of fields on the page.

Next, define the Option name for each item to include in your selection list. You also can set an Initial State (if any).

Selection - Configuration List – This field allows you to link to a predefined configuration list. When this data value is selected, the Element Definition area will update allowing you to indicate which configuration list you are going to display in the form.

See Configuration Lists for information on the lists available in this drop-down list.

Number - Integer – This field provides an integer field within the form. Only whole numbers can be entered into this field. When setting this data value, you can specify an Initial Value, if any.

Number - Numeric – This field provides an integer field within the form. Only whole numbers can be entered into this field. When setting this data value, you can specify an Initial Value, if any.

The Float Position drop down list lets you specify the number of digits to display after the whole number. If the Float Position is set to “3”, when the form is submitted, a value set to “34” will display as “34.000”. A value of “34.1” in this field would display as “34.100”.

Number - Form Sequence – This number is auto-generated and reflects the number of times the user has added a new form.  It does not contain a field for user input, as seen in the image below.

Date - Today – This will automatically insert the current date when the user is filling out the form, as seen below.

Date - Selection – This provides the user with a popup calendar that displays the current month by default. Using the arrows within the calendar the user can select previous or upcoming months and years. Once a date is selected, it will be added to the form, as shown in the screenshot below.

Label – Text – A label can be used to provide a warning or give more information to the user. Notice that after selecting this item, the data value details page will change, as seen in the image below. This is because no data values or column name are associated with the label text (It does not take in any input from the user). In order to display the wanted information to the user, enter the text into the Element Info field.

Table – This data value allows you to define a table within the form. The table can be configured to contain as many rows and columns as needed. You can also choose to build a table that allows users to add additional rows.

When you initially select “Table” from the Data Type drop down list, the page will refresh allowing you to specify the details about the table.

Note: A table data value creates an additional Table in the database. iRIS will auto-assign a Database Table Name in place of the Database Column Name that is un-editable. Data entered into this table within the form will be saved to the table displayed here.

Dynamic Table – Specify here whether the table is dynamic, meaning, a user can add as many rows as needed to the table. When you choose “Yes” here, the How many rows field will become un-editable.

How many rows – If you are defining a static table (the Dynamic Table option is “No”), then indicate the number of rows to include in the table.

How many columns – For either a static or dynamic table, enter the number of columns.

Element Definition – After you specify the number of rows and columns, save the page. When the page refreshes, this information will update based on the number of columns you specified.

The information you add to the Element Definition will populate as the column headers within the form.

Add data values –You will need to add the data values to the table for each row and column. After the initial save of the page, an Add a New Data Value button will populate below Element Definition. When you add a data value you will specify the Row Number, Column Number, and Order in Column in addition to the normal data value fields.

Example Tables:

When “Use Bulk Add:” is set to “Yes”, and the Dynamic Table in the first column has the KSP Personnel Selection data value, then the Dynamic Table will show the button “Load Initial Personnel from Study” in the form.

When Load Initial Personal from Study is clicked, a popup window will display when the user clicks the button. The window will show the list of Personnel on Study Selection previously inputted from the Study Shell.

For example, five personnel will add five rows to the dynamic table because five KSP were added from the study shell.

Please note: This function only works if the Study KSP Selection data value is in the first column. Under the Yes/No selection, there is a reminder:

If the Study KSP Selection data value is not in the first column, this new feature will not function properly and there will be no Load Initial Personal from Study button, or to “bulk” add KSPs.

 

Panel – Within Application Form Types and Submission Form Types, you can create panels to capture information. Panels are similar to a Dynamic Table data value, except instead of adding new rows as needed, users are able to add additional panel entries. The data in the panel displays in a linear form as opposed to horizontal rows as in a Dynamic Table. This allows you to create panels that can capture more information in a different layout than in a Dynamic Table.

The screenshot below displays a simple Panel within the Study Application form. When the panel is first displayed, it will display with only Entry 1. A user filling out the form can enter in information for Entry 1 and then add additional entries as needed. To add another entry to the panel, click on the Click here to add another entry button.

Entry 2 will be created as a separate tab in the panel, allowing the user to enter information specific to this entry. If an entry was created in error, click the Click Here to Delete this entry button. This will remove only the selected entry from the panel.

To set up a panel in a form, create a new data value and select the data value ‘Panel’ from the Data Type drop down list.

After selecting the Panel Data Type, the screen will refresh. The system will generate a column name for the panel, similar to creating a table data type. You will need to indicate the number of columns you need in your panel. Save the data value to refresh the screen.

After the screen refreshes, you will be able to add labels for the number of columns specified.

Labels added in Element Definition will appear in the grey area to the left of the data values in the panel.

Once the labels are defined you can add data values to the panel by clicking on the Add a New Data Value button at the bottom of the page.

Adding data values to the panel is similar to adding data values to a table. You select the Data Type from the drop down, specify the Database Column Name, indicate if the value is a required field, and specify the Column Number (this will correspond with the number of columns you indicated for the panel). Be sure to specify the Order in Column for items that are in the same column.

After you define the details for the data value click the Save Data Value button and then click the Cancel – Return to List button to return to the Panel.

Static and dynamic tables can be built within the panels. Create the table in the same way you would if you build a table outside of the panel.

The screenshot below shows a panel that has a dynamic table built into it. Any number of rows can be added.

Linked List – You can associate a Linked List to the form using this data value. When you select this data value from the drop-down list, you will then be able to specify which list to use.

These linked lists are configured within System Administration -> List Configuration & Maintenance -> System Setup -> Workflow algorithm and Forms Data types Setup -> Configuration System Linked List. See the Sys Admin - System Setup manual for additional information on setting these linked lists.

Current User – This data value will pull in the current user filling out the form. Note: This will merge the data as read only into the form.

Current User’s Email – This data value will pull in the current user’s email.

Current User’s Job Title – This data value will pull in the current user’s job title.

Current User’s Primary Phone – This data value will pull in the current user’s primary phone.

Current User’s Study List – This data value will pull in the current user’s study list.

 

 

 

 

 

Study Submission Data Values

This area allows specific Study data values to be associated to the form.

Submission Reference Number – This data value will merge the unique submission reference associated to that particular submission. Note: When the form is initially created, a reference number will not appear in this value, as no reference number has been applied to the form. Once the form is submitted, a reference number is generated and assigned to the form and will populate, read only, in the data value.

Submission Form Name – This data value will merge the Submission Form Name associated to that particular form. Note: This will merge the data as read only into the form.

Master Lay Summary – The current Master Lay Summary will populate in this field. If a Mater Lay Summary is not yet associated to the study, this field will be empty. You can click the button to open an editor to modify or add the Master Lay Summary.

Additionally, this data value can be made editable to the IRB Coordinator (depending on your systems configurations), after the form has been submitted to the review board, as seen in the image below.

Study Modifications Submissions – This value will allow Submission for Study Modifications to display.

Study KSP Selection – This value will display the user with a dropdown list of all of the current Key Study Personnel and will allow them to make a selection from these users. This is also customizable – in the example below it is

Selection – Combo box from table two Column Selections – This data value only works alongside the table data values and pulls from the values already configured within those tables. Once this value is added in a form with tables it will give additional selections and ask for the table to be selected as well as the table’s data values, as seen in the image below.

Once this has been setup, the columns selected will combine into a separate combo box within the form based on the user’s selections in the table, as seen in the image below.

Submit to Review Board – This data value will provide a Sign and Submit button within the form.

System Attachment Study Data Value Fields

This area will allow you to associate study data values which pull from system wide lists, such as sponsor lists and drug lists, and can pull items currently associated to the study. The data values in this list do not require additional setup items aside from the Database Column Name, unless otherwise noted.

Link to Study Documents – This data value allows the user to associate Other Study Documents to the submission form.

 

Link to Study Attachment/Sub Form – This value will allow you to link to the available Attachment / Sub Forms. When users are presented with this data value, they will be able to select which attachment form to complete and associated to the submission form.

The attached form will display in the table below the data value.

Link to Study Consent Documents – This data value allows the user to associate Informed Consents to the submission form.

Link to Contract Documents – This data value allows the user to associate Contract Documents to the submission form.

Link to Study Application – This data value allows the user to associate a revised Application form to the submission form.

Study Budget – This data value links the Budget Worksheet to a form, as seen in the image below. When the user selects to attach a budget, they are directed to Add a New Budget or to select an existing budget. Study Budgets are also created within the Study Management area of Study Assistant, depending on how your system is setup and is only available for systems with the Subject Management and Finance modules.

 

Study Sponsor Matrix – This allows the user to select a Sponsor from a list predefined in List Configuration and Maintenance –> System Setup –> Business Associate List, as seen in the image below.

Study Prime Sponsor Selection – This allows the user to select a Prime Sponsor from a list predefined in List Configuration and Maintenance –> System Setup –> Business Associate List. When using this data value, you are only able to add one sponsor to the study or project.

Study Prime Sponsor Contact – This allows the user to add a contact to the Prime Sponsor.

Study Sponsor Selection– This allows the user to select a Sponsor from a list predefined in List Configuration and Maintenance –> System Setup –> Business Associate List. This value allows you to add more than one sponsor to the study at a time.

Study Sponsor Contact – This allows the user to add a contact to the Sponsor.

Study Sub Recipient Selection – This data value allows the user to select a Sub Recipient from a list predefined in List Configuration and Maintenance – System Setup – Business Associate List.

Link to Attachment/Sub Form – This value will allow you to link to a specific Attachment / Sub Form type. Unlike the data value Link to Study Attachment/Subform, which gives the user the ability to choose which form they would like to complete, this data value already has a specific attachment form associated to it. When this data value is selected in the Forms Designer a list of the Published Attachment/Sub forms that have already been created will display in a dropdown. Select the form you wish to attach. You can also specify whether or not the Attachment Form content should display within the submission form, or just show as attached.

Example of content displayed within the Submission Form:

Associate this Study with Projects – This data value can be used to link a Study record with Project records in the system. This data value will only be available in systems that are using the eProposal module.

Associated Studies Link (in Study Application Forms) – This allows users to link other studies to their study when the data value is added to the application. A section for linking studies will be displayed and will contain a button called Search/Link Study to Studies”. After clicking on the “Search/Link Study to Studies”, an ajax window will appear and after searching for the desired studies, users can link the searched study to their study by clicking on the button. The Associated study will not be viewed by both the board and the study side by navigating to the study’s Study Summary screen and clicking on the “Associated Studies” link.

Study Personnel Request – This value looks similar to section 3.0 of the Study Application where personnel are initially added to the study. This value will allow the user to specify any additional users that need to be added to the study, by adding them to the appropriate group and selecting their role. Any user added to the study will have the ability to access the study in iRIS but not until the review board approves the change in personnel. This value will also allow the user to request the removal of a user from the current list of personnel by selecting the Remove button at the bottom of the table and selecting which personnel should be removed.

Any personnel requested changes will not take effect until the review board receives the submission and approves the change.

The availability of the Study Staff personnel and Faculty Advisor will be dependent on your System Configurations settings. See the Sys Admin –List Config – System Setup Manual for more details.

Study Personnel Training Validation – This data value functions similar to the Study Personnel Request data value; however, this data value will list out the current Key Personnel on the study along with their current training status.

From this data value you can request to Add, Remove, or update a user’s current role by selecting a new role from the drop-down list.

Any personnel requested changes will not take effect until the review board receives the submission and approves the change.

Study Drug/Biologic/Chemical agent – This data value allows the user to associate study drugs to the study. For studies that already have a drug associated, the drug record will populate in the table. Modifications can be made by clicking on the icon in the Edit column. Note that any changes requested will not be made until the review board approves the change.

Study Device – This data value allows the user to associate study devices to the study. For studies that already have a device associated, the device record will populate in the table. Modifications can be made by clicking on the icon in the Edit column. Note that any changes requested will not be made until the review board approves the change.

Study Agent – This data value allows the user to associate agents to the study. This feature works with the IBC module.

Study External Personnel – This data value allows you to capture External Personnel on the study. External Personnel allow you to capture study personnel that do not have User Accounts in iRIS.

Enrollment Tables – The data values shown here allow you to pull in three different types of enrollment information into your forms.

Each table will display information related to the Ethnic and Racial categories for the subjects on the study or planned to be enrolled onto the study. When you use these data values in the form, they will update to the enrollment tables within Study Management.

 

Study MedDRA Code – This data value will link with any MedDRA codes uploaded to iRIS. The MedDRA codes are stored within System Administration -> List Configuration and Maintenance -> MedDRA Code List. Your institution is responsible to obtain the necessary MedDRA list in order to use this feature in iRIS.

Study Inclusion/Exclusion/Workup/Treatment Criteria – These data values will pull in the specific criteria into the form and allow you to add additional criteria or edit existing.

When you use these data values in the form, they will update to the corresponding tables within Study Management.

 

Study Profile Fields - The following fields can be used to update fields within the Study Profile. When you select one of these values, you will only need to supply the Database Column Name. Some of the fields link to configuration lists within System Administration -> List Configuration and Maintenance and are noted below.

When data is initially set in these forms, they will save to the Study Summary page, as well as within the form.

  

 

Select Adverse Event – This data value will provide a link to other forms of the same type created on the same study. This is only used for Adverse Event form types.

When you click the link, a list of previously completed Adverse Events for the study will populate in a new page. You can select the Adverse Event to which you are sending a follow up, and then click the Save Selected Event button.

Information related to the initial report will populate in a table below the data value. The rest of the Adverse Event form will populate based on the information completed in the Initial Report. You can save through the form, verifying the information is correct, and change items as needed.

Any Adverse Event that you create as a Follow-up Report will become associated to the Initial Report in the list of Adverse Event forms. You can expand the folder in the Show Follow-up column, to view and Follow-up reports.

Study Plan –This data value will allow you to attach the study plan and submit it to a finance review board. This value should only be used for system’s that use the Finance module with Study Management.

Subject Fields – These fields allow you to capture subject specific information within the form.

 

Use Subject Tracking allows you to set the Study in Subject Management Mode. This value should only be set in the Study Application so that the study is set properly at study creation. Note: This question is also asked within the Study Shell upon study creation, if Subject Management is enabled in your system. This data value allows you to ask the same question in a different section of the form.

Subject’s Participant Number and Subject’s Initials, allows you to enter the appropriate information in to the field. These two fields are helpful for forms that are related to a specific subject, like an Adverse Event form. If your system has Subject Management enabled, the information related to the subject will populate in these fields (only when your form has the Prompt for Subject flag enabled within Edit Form Details).

Subjects enrolled will display the number of currently enrolled subjects on the study. In order to be considered enrolled, the subject needs to have a Subject Status with the “Status represents the subject is actively enrolled in the study” flag enabled. This ensures that off study subjects do not count in this number. Note: This field is only applicable with Subject Management enabled.

Study Classification – This drop-down list links to the Study Classification configuration list defined within System Administration -> List Configuration and Maintenance -> Site List Setup -> Study Classification.

When the Study Classification is defined within a form, it will also update to the Study Profile within Study Management.

Clinical Tasks – This data value will allow you to pull in Clinical Procedures that will be used on the study.

When you initially click this link, a page listing the procedures will open. Click the Add Procedure to the study button.

A new page will open that lists all the Clinical Procedures available in the system. This list is configured in System Administration –> List Configuration and Maintenance –> Site List Setup – > Procedure List/Charge Master. You may search for tasks by using any of the filters: CPT Code, Procedure Name, Category Name, Group Name, or All. After entering search criteria, click the Search button. When you locate the necessary procedures, select the checkbox(es) next to their names and click the Save Selected Procedure(s) button.

The selected procedures will then be added to the Study Procedures list, as shown in the screenshot below. Procedures can be removed from this list by clicking the procedure selection, then clicking the Delete Selected Procedure(s) button. Click the Return back to the Application button to return to the form.

Note: This value is only applicable when Subject Management with Finance is enabled in your system.

Outstanding Stipulations Comments that must be addressed – This data value can be used to pull in any Comments that must be addressed so that a study can respond to stipulations outside of the Review Response or Pre-Review Correction Form for items that have a different due date.

Stipulation types “Comments that must be addressed” that have not been responded to will populate. Using this data value, personnel on the study can indicate whether or not the stipulation has been accepted and addressed.

BMI – Allows you to input a Body Mass Index generator into the form.

Study (Merge Field from Database)

This group of data values allows you to pull information related to the study or system into the submission form as a read only value. For example, the Study Number field will pull in the current Study Number associated to the study and display as a read-only field. Each item in this list is self-explanatory and will not be listed out individually. The fields available can be viewed in the screenshot below.

IRB (Merge Field from Database)

This group of data values allows you to pull information related to the study’s associated IRB into the submission form as a read only value. For example, the IRB Number field will pull in the current IRB Number associated to the study as a read-only field. Each item in this list is self-explanatory and will not be listed out individually. The fields available can be viewed in the screenshot below.

IACUC (Merge Field from Database)

This group of data values allows you to pull information related to the study’s associated IACUC (these fields are only applicable if your system is using the IACUC module) into the submission form as a read only value. For example, the IACUC Number field will pull in the current IACUC Number associated to the study as a read-only field. Each item in this list is self-explanatory and will not be listed out individually. The fields available can be viewed in the screenshot below.

 

IBC (Merge Field from Database)

This group of data values allows you to pull information related to the study’s associated IBC (these fields are only applicable if your system is using the IBC module) into the submission form as a read only value. For example, the IBC Number field will pull in the current IBC Number associated to the study as a read-only field. Each item in this list is self-explanatory and will not be listed out individually. The fields available can be viewed in the screenshot below.

 

 

Miscellaneous Data Value Fields

 

Form Completed ---- Close Form – This data value will cause the form to complete when clicked, as opposed to saving through the entire form until the last section is reached. This value will not initiate routing or submit the form into the workflow.

Existing Form Variable – This data capture field will allow you to select from a list of data values defined in a previous form. When creating this data value in your form, this section will display a list of forms that you must first select. After a form has been selected it will display another list of data values to select from within the previously selected form, as seen in the image below.

This data value will allow you to display the answer to another data value from another form. Note: often times this data value will be added and set as Read-Only to users so that the previous answer is not changed, but still displays for the user and within the form.

User Selection – This data value will allow a user to be selected from the system directory, as seen in the image below.

When click Add Selected User, the Search User Directory page will open, allowing you to search the iRIS user database. Use the Last Name, First Name, and Department Filters to find the user, then click the icon in the Select User column.

The user will be added to the table within the form. You can add any number of users to this value.

Electronic Signature

PI – This allows the PI to provide their electronic signature.

When the PI on the study clicks this link, s/he will be able to add an electronic signature and save the page.

The data value within the form will update to indicate that the signature has been applied.

Current Logged in User – This allows the Current logged in user to provide their electronic signature.

When the user completing the form clicks this link, s/he will be able to add an electronic signature and save the page.

The data value within the form will update to indicate that the signature has been applied.

*Note: electronic signatures for study personnel and department approvals can all be captured using the Submission Signoff Routing Process when a submission form is sent in the workflow. These data values are available to use in forms, but a more detailed and streamlined process can be used with the routing process. For more information on electronic signatures, see the Study Submissions manual.

Return Response / Correction Form Type - Specific Data Values

Some of the specific form types described earlier in this manual contains their own unique form specific data values, which are only available when creating this form type. The Return Response Data values are described below. Many of these Data Values are crucial to the Return Response forms correct processing. For example, the Stipulation Data Values pull the stipulations sent from the review board. Without this data value in the form the study would not be able to submit corrections.

Review Response Stipulations – This will list any stipulations that the review board has put into the submission, regardless of the Stipulation Type. All stipulations added to the form will display with this data value, one listed after the other.

If you want to break out the stipulations by Stipulation Type, use these data values in place of the Review Response Stipulations data value.

Review Response Stipulations Conditions that must be met – This will list any stipulations designated as the stipulation type “Conditions that must be met”.

Review Response Stipulations Comments that must be addressed – This will list any stipulations designated as the stipulation type “Comments that must be addressed”.

Review Response Stipulations Comments – This will list any stipulations designated as the stipulation type “Comments”, which can take place of the Review Response Recommendations data value, listed below.

Review Response Recommendations – This will list any recommendations made by the review board to the study and allow them to make corrections if needed. This data value will only be used if you use the Recommendations tab within the Submission Processing screens in place of adding Recommendations to the Stipulations area under the Stipulations Type “Comments”.

Review Response Previous Submission Form – Use this data value to allow a link to revise the submission form and any supporting documents. This value would only be used if you are not allowing the user to modify the submission components through the Stipulations. Also note, in order for this value to work properly, the System Property within System Signoff and Submission Settings “system.use_response_wizard_window” must be set to “No”.

When you click this button, the system will confirm the revision. When you select “OK”, the system will revise the submission form, and open the form so you can make necessary edits.

 

If the revision is for the Initial Review Submission, you will be able to navigate to any section to modify any attached form or document or add consents and other study documents as needed. When you are finished, click the Close Form button to return to the response form. Any changes you made will be associated to the response form and will be sent to the review board when the response form is submitted.

Submission Packet – Revisable Forms and Documents – This will display the current submission form, with all the components of the submission. From this area, a user can view any of the forms and documents and choose to modify or update existing items.

Note: if the system property located within the System Signoff and Submission Settings group “system.use_response_wizard_window” is set to “No”, all changes to the submission and its components must be done using the Review Response Previous Submission Form. The Modify/Edit Submission button will not be available within the Submission Packet – Revisable Forms and Documents data value.

Review Response Committee Action Letters –Outcome Letters can be assigned to submissions being returned to the study. Any letter generated and sent related to the submission will display in this data value when it is returned to the study.

Submission – Assigned Analyst – Allows users to display the analyst assigned to the latest round of a submission within Response and Correction forms has been added to iRIS.

Reviewer Checklist Form Type – Specific Data Values

Some of the specific form types described earlier in this manual contains their own unique form specific data values which are only available when creating this form type. The Reviewer Checklist Data values are designated below. Many of these Data Values are crucial to the Reviewer Checklist forms correct processing. For example, the indication of completion triggers a notification that allows the IRB Coordinator to know that the Reviewer has completed their review and will cause the Reviewer’s assignment to flag as closed.

Submission Packet – Forms and Documents – This data value is one of the most important data values for the Reviewers Form, this value will merge the Submission forms and documents for the reviewer to access directly, as seen in the image below. Note: it is highly recommended that this data value always be available at the beginning of the reviewer’s form in order to provide your reviewers with easy access to the submission they are reviewing.

List of Reviewer’s – This data value displays a list of the reviewers already associated to the submission, as well as the status of their review, as seen below.

Reviewer’s Comments – This data value provides a field for the reviewers to enter comments, as seen in the image below. These comments will then merge into the Reviewer Checklist and Comments area of the Pre-review Processing screens and can then be merged into Stipulations, Minutes, or Letters.

 

Reviewer’s Indication of Completion – This data value allows the reviewer to indicate their completion of the submission review, as seen below. When this value is set from “No” to “Yes” by the Reviewer, and then the form is completed, the Reviewer’s task will mark as complete and the analyst assigned to process the submission will be notified that the reviewer has completed a review.

Submission Reference Number – This data value will merge the unique submission reference number associated to that particular submission. Note: This will merge the data as read only.

Shared Board/Committee Reviewers Forms – This data value allows reviewer forms to be viewed across additional review boards. In addition to setting this data value in a form, the RB Coordinator from the review board “sharing” the reviewers form, must set that the “share review with other boards” for that particular submission as seen in the image below.

Once these configurations have taken place, the reviewers form will be available within the additional board’s reviewer’s form.

Shared Board/Committee Letters – This data value works much like the data value above “Shared Board/Committee Reviewers Forms” although it is available for sharing outcome letters across review boards. In addition to setting this data value in a form, the RB Coordinator from the review board “sharing” the Outcome Letters must set the “share with other review boards” for that particular submission as seen in the image below.

Once these configurations have taken place, the outcome letter will be available within the additional board’s reviewer form, as seen in the image below.

COI Match objects under review – This data value is used within the Reviewer Checklist for the COI Module. This is used in place of the Submission Packet – Forms and Documents data value and will display information related to the Conflict Match under review. This data value should only be used in the COI Reviewer Checklist.

 

Study History Menu – This data value allows the reviewer to access the Study Menu drop downs at the top of the screen, as seen below.

 

These dropdowns contain information related to the study as a whole, including Protocol Items, Study Management tools, User Training, other Submission forms, as well as Additional Attached forms. Note: placing this data value anywhere in the reviewer’s form will display these dropdowns at the top; it does not need to be placed in any particular section or question.

Submission Discussion – This data value allows the Submission Discussion tab within the Pre-review Screening of submission processing to be merged into the Reviewers form. Note: This will merge the data entered as read only.

Submission Stipulations – This data value allows the Stipulations for that study to be linked into the Reviewers form, as seen in the image below. This information merges into the Stipulation tab of submission processing, as seen in the image below.

 

Submission Outcome – This data value will provide the reviewers with the ability to set the Review Outcome for that particular submission. As seen in the image on the left below, the Review Outcome drop down is available in the Pre-review Processing of a Submission. This data value provides that same dropdown to Reviewers as seen in the image on the right. Note: Allowing the reviewer to set this information will update the Outcome information for the submission but only if the Review Board Property “rb.use_reviewer_outcome_data_values” = “Yes”. This property is located within Review Board Configuration Options in the Reviewer group.      

Submission Approval Date – This data value provides the reviewer with a Submission Approval Date field, as seen below. Note: Allowing the reviewer to set this information will update the Outcome information for the submission but only if the Review Board Property “rb.use_reviewer_outcome_data_values” = “Yes”. This property is located within Review Board Configuration Options in the Reviewer group.

 

Submission Follow-up – This data value will provide the reviewers with the ability to set the Review Follow-up Due date for that particular submission. As seen in the image on the left below, the Follow-up due date is available in the Pre-review Processing, Outcome tab of a Submission. This data value provides that same ability to Reviewers as seen in the image on the right. Note: Allowing the reviewer to set this information will update the Outcome information for the submission but only if the Review Board Property “rb.use_reviewer_outcome_data_values” = “Yes”. This property is located within Review Board Configuration Options in the Reviewer group.

      

 

Submission Comments for All Reviewers – This data value allows the IRB Coordinator to indicate comments that they would like displayed for all Reviewers. With this data value configured, the Pre-review Screening tab of submission processing allows the IRB Coordinator to associate the reviewers to the submission, as well as associate comments for all reviewers, by selecting the View Comments for All Reviewers button, as seen in the image below. Note: This will merge the data entered as read only into the reviewer’s form.