Please note: A PDF version of this guide is available for download at the bottom of the article.
This manual outlines the process of creating a study in iRIS™ and submitting that study to a review board. This process includes creating an initial application, completing a submission form, and addressing any responses or corrections requested by the review board.
Add a Study
To begin, click the Create a New Study button in the ”Featured Study Operations” panel of Study Assistant Workspace or via the “My Workspaces” drop-down navigation menu.
Selecting an Application
Clicking Create a New Study redirects the user to the application selection page below.
Note: If your system only contains one Study Application Form, clicking Create a New Study will bypass the above screen and take the user directly into the first section of the form.
The number and nature of applications that display on this application selection page is dependent on the modules being used by your institution. The form names and descriptions are configurable by your institution and may not look like the examples shown in this document.
To continue creating a new study, select the desired application from the screen above and then click the Start selected Application button. If you do not need to create a new study at this time, click the Cancel and Return button to return to the Study Assistant Workspace.
Multiple Users Accessing Forms Simultaneously
In the event that two users are accessing the same section of a form, the user that accessed the section first will have the ability to edit that section of the form. The second user will receive the following message and the form will load in read-only mode.
Once the first user has left the section, the second user will receive the following message informing them that the other user has left the section. The user will only receive this message if they are still accessing that section of the form.
The Study Shell
Once an application form is selected and Start selected Application is clicked, the user will be taken into form’s “Study Shell”.
In iRIS™, the Study Shell comprises the first three sections of every study application form. These sections allow the user to define the general identifiers for the study and assign Key Study Personnel. The Study Shell is the only area of study application forms that is not configurable and is universal for all forms of that type in the system.
1.0 General Information
The first section of the Study Shell is General Information. All newly created application forms will open to this section by default.
Here the user may define the full title of the new study as well a study number identifier. Both of these fields are required and must be completed before the user can continue through the Study Shell.
If the Subject Management module is activated, the following additional question will appear at the end of the General Information section.
Answering “Yes” to this question enables the use of Subject Management functionality for this study once it is approved by the appropriate review board.
Once all required fields have been completed, the user may click the Save and Continue to the Next Section button in the upper right corner of the screen as shown below.
This will save the information entered on the General Information page and take the user to the next section, which in this case is the second section of the Study Shell: Add Department(s).
Clicking Save Section instead will still save the General Information data and refresh the page, but not redirect the user to the next section.
2.0 Add Department(s)
The second section of the Study Shell enables the user to associate the study with one or more departments defined in the system. Note that Department Administrators will be able to pull data from the study into certain reports based on the Department(s) chosen in this section.
By default, the system will pull in the form author’s primary department as the potential primary department for the study. This can be changed using the Add Department and Remove Department buttons.
Adding Departments
Departments may be added to the study by clicking the Add Department button.
This will open the following window.
The table in the window above lists all departments defined in the system. Four filters and a Search button are provided above the department table to aid in the search process.
One or more of these departments may be added to the study by checking the appropriate “Select” checkboxes and clicking the Save button in the bottom right corner.
This will add the select department(s) to the study application form as shown below.
Setting a Primary Department
By default, the initial department is set as the study’s primary. This is easily modified by clicking the desired department’s Is Primary? radio button and saving the section.
Removing Departments
A department may be removed from the study by selecting the department’s checkbox and clicking the Remove Department button as shown in the screenshot below.
Clicking Remove Department prompts the user with the confirmation message shown below.
Confirming this message refreshes the form page with the selected departments removed.
After the desired changes to the study departments have been made, click the Save and Continue to the Next Section button to continue to the last section of the Study Shell.
3.0 Key Study Personnel (KSP) Assignment
The third section of the Study Shell involves the assignment of Key Study Personnel (KSP). Each question on this page represents a role that is available to add to this study. When adding KSP, a user will assign them one of these available roles.
Depending on your system configuration you may see different role requirements than the example below.
Role Descriptions
Some of the roles available in this section include the following:
Principal Investigator – All studies in iRIS™ must be assigned a Principal Investigator (PI). Without a PI, the third section of the Study Shell cannot be completed and the study will remain in Draft mode. Note that there may only be one PI per study. If additional PIs exist, add them to the “Additional Investigators” section.
Additional Investigators – Any non-PI investigators. There is no limit to the number of Additional Investigators that can be added to a study. Each user in this section is given a specific study role.
Research Support Staff – Any non-investigator study personnel. There is no limit to the number of Research Support Staff that can be added to a study. Each user in this section is given a specific study role.
Contact – User(s) on the study who will receive study related notifications from the system, such as Continuing Review notifications, Submission Correction notifications, Review Response notifications, etc. The Principal Investigator defaults as the study contact, but this is editable. Any number of contacts be defined for a given study.
Department Administrator – If a study requires department approval before being submitted to a review board, a Department Administrator (DA) may be added. This administrator will appear in the form’s submission routing configuration, giving users the ability to send the application to the DA before being approved by a review board. More details on this process are given later in this document. Any number of DAs may be defined for a given study. Users added as DAs will populate in the “Designated Department Approval(s)” section of the Study Shell section 3.0.
Adding Key Study Personnel (KSP)
To add a user to the study, first click the Click Here to Setup Study Personnel button next to the section title. The following pop-up window will appear.
There are two methods to add KSP using the window above: manual search and personnel pool. Both will be described below.
Manual User Search
One approach to adding a user to a study application is to navigate to the User Search By Study tab (open by default) and manually search for the desired user.
A help message is displayed on the left side of the window providing further information on the functionality and purpose of this tab.
Three filter fields are provided to help narrow down the search results: last name, first name, and department.
From this search results display table the users’ department, contact information, training history, and study associations may be viewed.
Once the desired user is found, they can be added to the study by clicking the icon. Clicking this icon opens the following secondary pop-up window.
Notice that the available roles match those displayed in the form as the section questions.
The user can then be assigned a role on the study by clicking the desired radio button. Once a role is selected, an additional field may appear asking if the user should be added as contact.
Lastly, additional responsibilities may be assigned to the user by clicking the Add/Modify button, which opens a third pop-up window as shown below.
Any selected responsibilities will populate next to the Add/Modify button.
These role responsibilities are configured in System Administration via System Administration 🡪 List Configuration and Maintenance 🡪 Define Study and Project Responsibilities.
Each responsibility may then be assigned customized access to Study Assistant via the Study Assistant role matrix (System Administration 🡪 List Configuration and Maintenance 🡪 Define Study Assistant Role Access).
Once a role and optional responsibilities have been defined, the user can be added to the study by clicking Save.
A record of the newly added user will populate in the appropriate role table.
Closing the Setup Study Personnel window shows that the user has been successfully added to the study.
Notice that John Investigator was added both as a Principal Investigator and a Study Contact due to the fact that the Would you like to include as a Contact? field was set to “Yes”.
The added user can be deleted from the study by again clicking Click Here to Setup Study Personnel and then clicking the icon.
All users may be removed from the study by clicking the Clear Key Study Personnel button. Note that if a Principal Investigator is removed from the study the system will require a replacement PI to be chosen before the original is deleted.
Viewing User Training Details
Clicking the icon opens the secondary pop-up window shown below, detailing the user’s training information.
The window above is from the point-of-view of a user with read-only access to KSP training information. Clicking Cancel closes the training details window.
If the user instead has read and write access to training data, clicking the icon will redirect the user to the following page.
This screen allows the logged-in user to both view and edit the KSP’s training records. Clicking the Back button will return the user to the section 3.0 of the application’s Study Shell.
KSP training access is determined by a study role property that is configured in System Administration (see the System Administration – List Configuration and Maintenance manual for more details).
Viewing User Study Associations
A user’s study associations may be viewed by clicking the icon in the user search display table.
Clicking this icon will open the following secondary pop-up window.
All studies that the selected user has been designated as a KSP on will populate in this display table. The format of the column’s headers may be modified using the Display Studies by combobox.
Personnel Pools
The second method to add users to a study is to use personnel pools. A personnel pool is a pre-defined KSP configuration, composed of one or more users with pre-assigned roles. This method is especially useful for scenarios where the same personnel and roles are added to many different studies.
To use a personnel pool, first navigate to the Study Personnel Pool tab as shown below.
Use the Select The Pool you want to Apply combobox to open a personnel pool. All pools that have been created by the current user will populate in this drop-down menu.
Selecting a personnel pool will refresh the display table to show all users defined in that pool.
This “General Research Personnel” pool consists of the users Sean Coordinator (Principal Investigator) and Betty Smith (Contact). In order to add one of these users to the study, simply click the select icon. Doing so will bypass the intermediate role configuration pop-up window and directly add the user to the study.
Creating Personnel Pools
To create a new personnel pool, navigate to the Create My Personnel Pool tab.
This page allows the user to create a new pool based on the current KSP configuration for the study. For example, in the screen above, this new pool will include John Investigator (Principal Investigator), Sean Coordinator (Additional Principal Investigator), Tom Jefferson (Co-Investigator), George Jefferson (Nurse), and any others not visible in this screenshot.
If any KSP should be excluded from the new personnel pool, they must be deleted from the study before saving this pool configuration.
Once the appropriate users have been added to the study, the new pool can be saved by entering a name for the pool and clicking the Save button.
This new “Research Personnel Pool – Oncology” pool will now populate in the Study Personnel Pool tab.
Updating a Personnel Pool
Navigate to the Update My Personnel Pool tab to update a pool.
All pools associated to the current user will populate in this table.
Once a pool is selected, a new field will appear allowing the user to change the pool’s name.
Saving this page will update the personnel pool to display the new name. Note that update is purely aesthetic and does not modify the actual pool KSP configuration. Once a personnel pool has been defined, the users in that pool cannot be changed, only the name of the pool itself.
Deleting a Personnel Pool
Users may delete one or more of their pools by navigating to the Delete My Personnel Pool tab. Click the icon to remove the pool.
Assign User(s) to Sections
After granting KSP access to the study, depending on the application form’s configuration, the Assign User(s) to Sections button may appear.
Click the button to open the Define Study Access screen. Displayed here is a list of sections that have been accessed by the form author. Accompanying each section is a combobox enabling a KSP to be assigned to complete that section.
Any user that has been added to this study via the Study Shell section 3.0 will populate in these drop-down menus.
Assign a user to a section by selecting their username in the drop-down. Once a user has been assigned to a form section, that section will appear as read-only to all other users. The assigned KSP will then receive a Form Section Assignment task to complete the section.
In the example above, George Jefferson has been assigned to complete the “Initial Screening Question” section. Saving this assignment and navigating to the “Initial Screening Question” section will show the following screen.
Note that a message displaying the name of the assigned user is displayed on the upper left-hand corner of the screen. This message only displays when the assigned section is opened.
Also notice that the fields in this section are read-only. This is because the current logged-in user is still John Investigator, and this section has been assigned to George Jefferson. From George Jefferson’s point of view, he will have received a task to complete this section, as shown below.
Opening this task takes Mr. Jefferson into the application form to complete the assigned section.
Notice that from George Jefferson’s point of view, the fields in this section are editable. To complete the section, Jefferson will simply select “Yes” for the Completed? field shown in the section header (red box in screen above). Doing so will complete the section and finalize the Form Section Assignment task.
From the form author’s point of view, once George Jefferson completes his assigned section, the status of this assignment will update to completed.
The section itself will remain read-only, but the left-corner message will update to show that it has been completed.
Custom Application Sections
The application sections following the Study Shell are customizable, based on the configuration of the Study Application Form.
To complete a section and move on, click the Save and Continue to Next Section button. If a required field is left blank, an error message will display.
Correct the missing field to save and continue. Below is an example of an error message that might display within the form.
Several unique data values often used in study applications to collect specific information are detailed below. These data values are added to Study Application Forms via the System Form Designer in System Administration and may or may not be present in your form.
Notes Regarding Form Navigation
Back Button: When completing the Study Application, it is important to remember that if you need to return to the previous section, DO NOT hit the Back button on your Internet browser. To properly navigate to the previous section, click on the link for that section in the navigation pane.
Navigation Pane: On the left side of the screen, a navigation pane builds as you progress through the application. Click on the link of a section at any time to move to that section. The section you are currently viewing will appear green, while the other sections will appear gray.
Help Icons: Some sections may contain help icons. Click or hover your mouse over the icon to open a window or a small pop up That has been configured to provide additional information about a certain question.
Study Drugs
The Study Drug data value enables users to search the iRIS™ database for a drug to add to their study. Any number of drugs may be added to a study.
To add a drug, begin by clicking on the Add a New Drug to the Study button in the Study Drug data value, as seen in the image below.
The following pop-up window will open.
Search for a drug by entering a full or partial drug name into the Drug Name text box and clicking the Find Drug button. If the text box is left blank, all drugs in the system will populate.
Click the icon in the Select column to add a certain drug. If the desired drug is not populating in this table, the user may create this drug by clicking the Add a New Drug button. This will update the window to show the following screen, allowing the user to specify the Trade Drug Name, Generic Name and/or Investigational Drug Name. Click Save Drug Info to add this new drug to the system’s master drug list.
Whether adding an existing drug by clicking on the icon in the Select column, or adding a new drug to the master list, the user will next be taken to the Study Drug Details screen as shown below.
This screen enables the user to associate study-specific information to the added drug. The questions below the blue bar are configurable via System Form Designer and may or may not appear different in you system.
Once the fields on this screen have been completed, click Save Drug Info to add this drug to the study.
You will be returned to the Study Application and the drug you added will appear in the table below the Add a New Drug to the Study button.
You may delete the drug by clicking the icon in the Delete Drug column. To edit the study-specific drug information, click the icon in the Edit column. You can also view the study-specific details by clicking the icon in the View Details column, as seen in the image below.
You can add additional drugs by clicking the Add a New Drug to the Study button and follow the steps listed above.
Study Devices
The Study Device data value enables users to search the iRIS™ database for a device to add to their study. Any number of devices may be added a study.
Begin by clicking on the Add a New Device to the Study button.
A popup window will open within your browser allowing you to search the system for the device you would like to add to the study. You can enter in all or part of the Device Name, Device Mode and/or Device Serial Number, or leave these fields blank and click the Find Device button to return all devices in the system.
Once your search returns results, you can select the desired device by clicking on the icon in the Select column.
If the desired device is not in the list, you can add a device to the system’s master device list by clicking the Add a New Device button.
Doing so will update the window to show the screen below, allowing you to specify the Device Name (required field), Device Mode and Device Serial Number.
When finished defining the new device, click the Save Device Info button to add the device to the system’s master list.
Whether you chose an existing device by clicking on the icon in the Select column, or added a new device to the master list, you will next be taken to the Study Device Details screen as shown below.
This screen allows you to enter study-specific information for the device. You may or may not see the same information listed on this page, depending on your system configuration.
The questions below the green bar are configurable via the System Form Designer. When the fields in the above window are complete, click on the Save Device Info button to add the device to the study application.
You can delete the device by clicking the icon in the Delete Device column. To edit the study-specific device information, click the icon in the Edit column. You can also view the study-specific details by clicking the icon in the View Details column.
You can add additional devices by clicking the Add a New Device to the Study button and follow the steps listed above.
Inclusion/Exclusion Criteria
The Inclusion Criteria and Exclusion Criteria data values allow inclusion/exclusion criteria to be defined for potential subjects on the study. You can add the criteria to your Study Application for board review, and later, for flagging which enrolled subjects meet each criterion.
The same process is used to add both Inclusion and Exclusion criteria. This is described below using Inclusion Criteria as an example.
Begin by clicking the Add a New Inclusion Criteria to the Study button in the Inclusion Criteria data value.
A popup window will open allowing you to specify the Order Number and the wording for the Criteria. The Order Number will default to 1.
The required Criteria field allows both copying and pasting and manually typing of the criteria description.
When finished, click the Save Criteria Info button. You will be returned to the Study Application and the new Inclusion Criteria will be listed in the table.
An additional Inclusion Criteria may be added as needed. Click the Add a New Inclusion Criteria to the Study button and repeat the steps above. Delete an Inclusion Criteria record by clicking the icon in the Delete column. Modify existing records by clicking the
icon in the Edit column.
Sponsor
The Sponsor data value enables you to search the system for a sponsor to add to your study. Depending on your system settings, you may or may not be able to add more than one sponsor to a given study. Follow the process described below to add a sponsor record.
Begin by clicking on the Add a New Sponsor to the Study button.
A popup window will open allowing you to search the system for the sponsor you would like to add. You can enter in full or partial Sponsor Names, Familiar Names and/or Legal Names, or leave these fields blank and click the Find Sponsor button to return all sponsors in the system.
If the desired sponsor does not appear in the table, you can add this sponsor to the system’s master list by clicking on the Add a New Sponsor to the Master List button. This feature is controlled by a system property, please contact your System Administrator for more information.
After you choose to add a new sponsor, the window will update allowing you to specify the Sponsor Abbreviation, Sponsor Name (required field), Sponsor Type (required field) and sponsor location information. When finished, click the Save Sponsor and add to Study button to add this new sponsor to the master list.
Whether you chose an existing sponsor by clicking on the icon in the Select column, or added a new sponsor to the master list, you will next be taken to the Study Sponsor Details screen as shown below.
The questions below the green bar are configurable via the System Form Designer. Once the appropriate fields have been completed, click the Save button to add the sponsor to the study. If a sponsor is given a “Funding Sponsor” role and your system has access to the finance area of Subject Management, you will have the ability to generate invoices for the sponsor when certain study events and milestones are triggered.
Once added, this sponsor will populate in the Sponsor data value display table.
You can delete the sponsor from the study by clicking on the icon in the Delete column. If your system is set up to allow only one sponsor per study, the button to add sponsors to the study will not appear once a sponsor has been added. If you delete the sponsor, the button will reappear, allowing you to add a different sponsor.
If your system does not restrict the number of sponsors allowed per study, you can add additional sponsors to the study by clicking on the Add a New Sponsor to the Study button and following the same steps as above.
You can view additional details related to the sponsor by clicking on the expand icon in the View Details column.
Sponsor Contact
Once a sponsor is added to a study, you may then associate one or more contacts to this sponsor via the Add a New Contact(s) to the Study data value.
There is no limit to the number of contacts that can be associated to a sponsor. Clicking Add a New Contact(s) to the Study will open a pop-up window allowing you to search the system for existing sponsor contacts. You can enter all or partial information in any of the search fields or leave these fields blank and click the Find Sponsor Contact button to return all sponsor contacts associated to the sponsor you added to the study.
If you cannot find the desired sponsor contact in the list, you can add a new sponsor by clicking on the Add a new Contact to the Master List button.
After you choose to add a new contact, the window will update, allowing you to specify the Contact Category, Division (required field), First Name (required field), Middle Initial, Last Name (required field), and additional information for the sponsor contact. When you are finished, click the Save Sponsor Contact Info button.
Once the contact is saved, you will be redirected back to the study application form where the sponsor contact has been added to the Contact data value display table.
To add another contact, click on the Add a New Sponsor Contact(s) to the Study button again. Delete a contact from the study by clicking on the icon in the Delete column. Edit a contact by clicking on the icon in the Edit column.
You can view additional details related to the sponsor contact by clicking on the expand icon in the View Details column. Your system may or may not have the fields shown in the screenshot below, depending on system settings.
Link Study to Project
The Link Study to Project data value will allow you to link your study to an existing iRIS™ project.
Begin by clicking on the Search/Link Study to Projects button. The window below will display allowing you to search for your project.
Enter your search criteria and click Find Projects.
Click on the icon to add the desired project to this Study Application.
You can click on the icon to remove the association to this project.
Initial Review Transition
Note: Not every Study Application will have an end like the one in the screen shown above, this is dependent on your system configuration.
Once the Study Application has been completed, the system will transition into the Initial Review Submission Form. This transition is signaled by the following pop-up window.
Clicking OK in this window will take the user into the Initial Review Submission Form as shown below. Note that this is independent of the original Study Application and does not mean that the application has reset.
The Initial Review form serves as the actual submission form that will be sent to the review board. The Study Application will be attached to this form, along with any informed consents and supporting study documents.
The mechanics of the Initial Review Submission Form are identical to those for the Study Application (navigating between sections, viewing tool tips, completing questions, etc.). Remember that the content and structure of this form is configurable and may not appear the same in your own Initial Review form. In the first section of this example Initial Review form a question about the type of research being conducted in this study is posed.
The second section in this example form displays some high-level study information pulled from the Study Shell of the application form.
Described below are some common data values used in Initial Review Submission forms. These may or may not appear in your specific submission form depending on your system configuration.
Lay Summary
The Lay Summary data value is a required field for most Initial Review Submission form. It captures the Lay Summary and/or Master Lay Summary for your study. The text entered in this data value will be used by the review board to gain an understanding of the overall goals and structure of the study.
Click the Click here to access the text editor button on the Lay Summary data value to create the summary.
A small popup will display, allowing you to copy and paste or type in the text of your Lay Summary. When you are finished, click the Apply button.
The window will close, returning you to the Initial Review Submission packet. The newly entered Lay Summary text will populate underneath the Lay Summary section.
Application Attachment
Because the purpose of the Initial Review Submission Form is to submit the Study Application to a board for review, one of the form’s section will include an Application Attachment data value.
For Initial Review forms, the Study Application will be pulled into this data value automatically. At this point no further actions are required, and you may continue to the next section. Later in the lifecycle of the study, if the review board has requested changes, you may have to revisit this data value to apply those changes, depending on the nature of the request.
For other types of submission forms, the Study Application is not pulled into this data value by default and instead must be added manually. In this case a Click here to attach the application button will appear.
Clicking this button will open a window listing the available Study Applications you can attach.
Because this is a new study, only one Study Application is visible.
To add this application, make sure it is selected and click the Save Attachment button.
Informed Consent Attachments
You may be directed to attach any necessary Informed Consent documents. Any consent document you upload to the Initial Review will be attached to the form and submitted for review. These documents will also be stored in the Informed Consent document library in the study record. If the review board approves the document, the approval information will update the document stored in the library. If your system is using Subject Management, you will also be able to update consent information for subjects on the study.
Add a consent to the submission by clicking the Add a New Consent button.
A small window will open asking for input on how you will upload the Consent document.
Depending on your system settings, you may or may not see the same options as above.
Both options are described below. Choose the appropriate action then click the Next Screen button.
- Add an informed consent master from the list of Informed Consent Template Documents?
Review boards may make consent templates available for you to download, modify, and then upload to the study. If you would like to download a copy and use the review board’s consent template, choose this option.
Selecting this option will present you with the ability to select the desired template from a dropdown list. Select the template and then click the Download Template button.
Depending on your Internet browser, version, and settings, you may or may not be prompted with the same file download information as below.
In this example, Google Chrome is used. The browser downloads the selected template and displays the file at the bottom of the screen.
Once the template is downloaded, you will be redirected to the Study Consent Add pop-up window shown below.
From this window you may upload the edited consent template that was downloaded in the last step. This is done with the Select the consent to upload field.
Once the document has been uploaded, complete the rest of the consent’s required fields, and then click Save Consent to add the document to the submission.
- Add an informed consent from an existing document you already have?
If you already have a consent document ready to upload, choose this option.
The Study Consent Add pop-up window will open.
The fields in this window are described below:
Consent Title – This is the title of the consent you wish to upload.
Select the consent to upload – This is where you can upload your consent form. You may drag and drop your file directly into the dotted box or click the box to open a file upload window.
Version Number – Requires you to specify the version number of the new consent. This can be any character or number. Placed after the editable version number is a hard coded ‘.0’. This is the iRIS™ version number for the consent. Any new document uploaded to the system will begin with the ‘.0’ affixed to your manually entered version number. Once a revision is made to the document, iRIS™ will change the ‘.0’ to ‘.1’. It will continue to increment the numbers each time a revision is made.
Version Date – This is the date of the manually entered version number. This is typically the date that the Consent document was uploaded to the system.
Category – This configurable drop-down list allows you to group documents into certain categories.
Language – This configurable drop-down list allows you to select which language the consent is written in.
Description – A description of the document.
Comments – Any comments regarding the consent document you feel necessary to add for the review board.
Enter the required information, then click the Save Consent button.
The Consent document will be uploaded to the study, and it will appear as attached to the Initial Review Submission Packet in the Consent Attachment section. You can remove the attached consent by clicking the icon in the Detach column. When you detach the Consent, you are removing it from the submission. If the record needs to be deleted, you will need to navigate to the study’s “Submissions” page and open the Informed Consent library. Once a document is submitted it cannot be deleted from the study.
Once a Consent document is uploaded, an additional button will populate within the Informed Consent data value called Select or Revise Existing. This button is available whenever you have documents in the Informed Consent library and allows you to select from the existing Consent documents on the study. You can also make any edits to the attached Consent, if needed, by clicking this button.
A new window will open, listing any existing Consent documents. Because only one record has been created for the study, only one record will display. It is already attached to the Initial Review Submission Packet, so you will not be able to re-attach it. To make changes to the document, click the icon in the Edit column.
This triggers the Study Consent Revision window to open, shown below. From here you can make changes to the Consent details.
You may check-out the document by clicking the Check-out Document button. Depending on your Internet browser, the download may require a few steps, but after it is downloaded you can edit the document outside of the iRIS™ system.
Once the document is checked out, you may return to the Study Consent Revision window. The page will indicate the document is checked out and will also give you the ability to check-in the document or undo the check-out with the Check-in Document and Undo Check-out Document buttons.
Once you have made changes to the document in Microsoft Word, you can check it back in by navigating to the consent data value in the Initial Review form. Click Select or Revise Existing, as shown in the image below.
Click the icon in the Edit column.
Click the Check-in Document button.
A popup window will open allowing you to browse your computer for the Consent document you would like to upload. Click the Save selected file button once you specify the document location. If you do not want to upload the document, click on the Cancel button.
Depending on the file size, you may see a message from the system indicating that iRIS™ is uploading the document.
You will then be returned to the Study Consent Revision window, with the document successfully checked in and associated to the study. Click the Save Consent button to apply the changes to the Initial Review.
Study Document Attachments
You may be directed to attach other supporting Study Documents. Any document you upload to the Initial Review Submission Packet will be attached to the form and will be submitted for review. The document(s) you upload will also be stored in the Other Study Document library in the study record. When the review board approves the document, the approval information will update the document stored in the library. From this library the document may be viewed, edited, and printed.
You can add as many documents as needed to the Document attachment data value. You can choose to add one document at a time, or if you have multiple documents, you can add them all at once using the Add Multiple Documents button.
Add a New Document
To add one document to the Document attachment data value, click Add a New Document. This will open the following window.
The fields in this window are described as follows:
Document Title – The title you would like to display for this document. If you did not enter the Document Title prior to uploading the document, the system will automatically apply the name of the document to the Document Title field.
Select the document to upload – Attach the document by dragging and dropping to this window. You can also click within the box to upload the file manually.
Version Number - Requires you to specify the version number of the new document. This can be any character or number. Placed after the editable version number is a hard coded ‘.0’. This is the iRIS™ version number. Any new document uploaded to the system will consist of the ‘.0’ affixed to your manually entered version number. Once a revision is made to the document, iRIS™ will change the ‘.0’ to ‘.1’. It will continue to increment the numbers each time a revision is made.
Version Date – This required field is the date of the manually entered version number. This is typically the date that the document was uploaded to the system. You may configure this field to auto-fill by turning on the system.auto_fill_version_date property.
Category – This configurable drop-down list allows you to group documents into certain categories. The categories displayed here are configurable via System Administration. This field may or may not be required based on the value of the system.doc_category_required property.
Description – A description of the document.
Comments – Any comments regarding the document you feel necessary to add for the review board.
Once the above required fields are completed and the document has been uploaded, click the Save Document button. The document will be uploaded to the study, and it will appear as attached to the Initial Review in the Other Study Documents Attachment section. You can remove the attached document by clicking the icon in the Detach column. When you detach a study document you are removing it from the submission. If the record needs to be deleted entirely, you will need to navigate to the study’s “Submissions” page and open the Other Study Document library. Note that once a document is submitted it cannot be deleted from the study.
Once a document is uploaded, an additional button will populate in the Other Study Document data value: Select or Revise Existing. This button is available when you have existing documents in the Other Study Documents library and allows you to select and edit these existing documents.
Add Multiple Documents
You can add multiple documents to the Document attachment field at once. Click on the Add Multiple Documents button.
This will open a popup within the browser. Here you will be able to specify details for multiple documents at a time.
Document Title, Version, Category, and File Path are all required fields. If necessary, you can also add the Version Date.
If you need to add more than five documents at a time, click on the Add New Record(s) button and an additional five rows will populate in the window.
Once you enter the desired number of documents and the necessary details, click on the Save Documents button.
Any document you uploaded will now display in the table.
The document details will display in the Other Study Documents attachment data value.
Once you upload at least one document, one more button at the top of the table is available: Select or Revise Existing. This will be addressed below.
Select or Revise Existing
Anytime you see this button available in the Other Study Documents attachment data value, it means that your study already has documents uploaded. Using this feature, you can select an existing document to add to the Initial Review Submission Form.
Clicking the Select or Revise Existing button will open the following popup window. Listed in the window will be any Other Study Documents associated to the study.
Attaching the Document
You can attach any document to the form by clicking on the icon in the Select column. This will associate the document to the form.
Note: If a document is already associated to the form (as is the case in the example above), no icon will display in this column. Also, you cannot delete a document that is associated to the form. If no icon displays in the Delete column, the document needs to be removed from the submission before it can be deleted (provided the document has not been submitted for review).
Checkout the Document for Editing
You can also edit the details of the document prior to attaching the document to the form by clicking on the icon in the Edit Details column.
This will open the Study Document Revision window. From here you can make any desired changes to the document details, or if you need to modify the content of the document itself, you can check out the document.
If checking the document out, returning to the Study Document Revision window will give you the ability to check-in the document or undo the document check-out via the Check-in Document or Undo Check-out Document buttons.
Click the Check-in Document button to check back in the document after the desired changes have been made.
A popup window will open allowing you to browse your computer for the document you would like to upload. Click the Save selected file button once you specify the document location. If you do not want to upload the document, click on the Cancel button.
Depending on the file size, you may see a message from the system indicating iRIS™ is uploading the document.
You will then be returned to the Study Document Revision window, with the document successfully checked in and associated to the study. Click the Save Document button to apply the changes to the Initial Review Submission Packet.
When the document is checked out, the page will read that the document is checked out and display the name of the user and the date that the document was checked out.
Viewing the Document
To view any document prior to attaching it to a form, click on the icon in the View the Document column.
Depending on your Internet browser settings you may need to allow the download or confirm a popup window asking if you want to Open or Save the file. In the example below, the user is using Google Chrome, and the file automatically downloads and is displayed at the bottom of the browser window.
Create Revision
You also have the ability to revise a document. When doing so, the system will update the document to the next version number, for example changing the version number from x.0 to x.1 when you choose to create a revision of a newly added document.
Signoff and Submit
Once the Study Application is complete and the required documents are attached, the form is ready to send to the review board.
You will be presented with a section in the form notifying you that the form is complete. Depending on your role on the study, and your systems signoff requirements, you may see different buttons on this page or a different notification.
If you are on the routing list for this form, the following buttons will appear.
If you are not the Principal Investigator on this study and the form requires a PI signature, the buttons on this page will be Notify PI to Signoff and Exit Form.
If your role on the study does not allow submission of forms, when you reach this page, you will only have the Exit Form button option. You will exit the form, and the Principal Investigator and Study Contact will be notified that a submission is waiting to be sent.
To initiate the signoff process, click the Signoff and Submit or Notify PI to signoff button, depending on which is available to you. At this point, you may be prompted to route for additional signatures.
You may choose to route for additional signatures if you need to have other study personnel review the form before it reaches the review board, or if you first need department approval.
If the Principal Investigator signature is required on this form, that user will be pre-selected in the personnel display table, and you will not be able to deselect them.
Select the name(s) of the any additional personnel you would like to include in the signoff process.
You can also add non-KSP reviewers to the signoff list by clicking the Add Additional Personnel to the Routing List button, as shown below.
This will open a new page allowing you to search the database for a user. Use the Last Name, First Name, Department search filters to find the user you wish to add, then click the icon in the Select User column.
The user you selected will add to the signoff list as shown below.
Make sure you check the checkbox next to users you want to include in the signoff process. You can also set the Order in which the users will receive their signoff task. iRIS™ will default each user to the order of 1, which means they will all receive their task at the same time. You can change this if one reviewer should receive the task before another.
Click the Save – Signoff Routing List button when you are ready to proceed.
This will take you to a summary page, displaying all the users you selected for the signoff process.
If you need to further modify the signoff list, click the Go back and Make changes or Cancel – Finalize later buttons.
When you are ready to initiate the signoffs, ensure you have selected “Yes” next to the question, ‘Please verify the list above represents the finalized Personnel for review and signoff?’. Doing so will enable the Save – Start Signoff Routing button as shown below.
If you choose “Yes” and click the Save – Start Signoff Routing button, and you are assigned to sign off on the application, you will be brought to the Signoff Page shown below.
If you choose “Yes” and click the Save – Start Signoff Routing button, and you are NOT assigned to sign off on the application, you will be brought to the Workflow Submission Tracking page and the users assigned to sign off will receive notifications from iRIS™ regarding their new assignments.
A user who is assigned to sign off on the Initial Review Submission Form/Study Application will receive a notification sent to the email address defined in their user account. They will also receive a Submission Routing Signoff task on their homepage. This task will remain on their homepage until the user opens the task and completes the sign off.
When the task is opened, the Submission Routing Signoff page will display.
At the top of the page, the Study Title and Submission Reference Number are listed. iRIS™ assigns a unique reference number to each form created in the system. The Reference Number displayed here is the number assigned to the Initial Review Submission.
Also listed on this page is a link to the Submission Components. This table contains a link to the Initial Review Submission Form, the Study Application, and any Consent and Other Study Document that has been associated to the form. This is the package that is being submitted to the review board for review. Before applying your signature, you can review any of the attachments and make any necessary changes.
If configured, you will also see a customizable Attestations section that can be set to require the user to agree to conditions set forth by the review board.
Some of the attachments are available to print. If a document can be printed, a check box will populate next to the document in the Include in PDF Packet column. You can select any of these items then click the Create PDF Packet button at the top of the table to display the following popup.
From here the user can click and drag to change the order of the items in the packet as shown below.
Once the order of the items is satisfactory, click the Generate PDF Packet button to create the PDF packet.
While the system prepares your documents, you may be prompted with the waiting icon above. Once the system has finished generating the PDF packet, a new browser window will open displaying this PDF.
You can save this PDF or print it. When you are finished, click the Close button.
Below Submission Components table you might be prompted to enter your electronic signature. You must indicate whether you Approve or Deny the submission then enter your User ID and Password then click on the Save Signoff button. Below the electronic signature portion of the page you will be able to see any other Key Personnel listed for signoff. If any of the additional signoffs have been completed, their approval or denial information will populate here.
If you select Approve, iRIS™ will assign the next user in the list their Submission Signoff Routing task and the submission will continue in the workflow. iRIS™ will then take you to the Study Assistant Workspace 🡪 Study Submission Status – In Progress panel with the submission status displayed for the submission as shown below:
If you select Deny, any other signoff task will cancel, and this signoff denial will be recorded in the submission history.
The Principal Investigator and Study Contact will also receive a Submission Signoff Denied task. This will allow the PI to make any needed corrections and then resubmit the application.
If the user wants to modify the Routing Signoff List, they can click on the Modify Signoff Routing List button in Submission History and the following window will appear.
Once all assigned users have completed their sign off tasks and they have indicated approval of the submission, the form will go to the review board’s submission queue for processing.
At any time during the sign off process, or while the review board is processing your submission, you can check the status of the form and where it is currently located. Open your study record in My Studies and navigate to the Submissions page. Your submission will display in the Outstanding Submission(s) queue. You can click on the icon in the Track Location column.
This will open the same Workflow Submission Tracking screen as that which opens after completing a signoff task. The workflow will update as the submission moves forward in its processing.
The screenshot above shows that the submission successfully passed required signoffs and has been received by the IRB, who has requested pre-review changes.
If users you have assigned have not completed their signatures, the Workflow would show that they are still in process. The Principal Investigator and the Study Contact would also receive notifications from the system to alert them that a certain user has not completed signoff yet.
Responding to Corrections
The review board may return items to you for correction. When a submission is returned for corrections, the Principal Investigator and any Study Contacts listed on the study will receive a notification from iRIS™ alerting them of the request. They will also receive a task on the homepage called Submission Correction or, if a review board has met on your submission and returned it for corrections based on the review, the task will be called Review Response.
The screenshot below shows a task for Pre-Review Changes, called a Submission Correction. This task will remain on your homepage until you respond to the corrections and resubmit the form to the review board. Click the icon in the Open column to open the Pre-Review Corrections form.
When you open the task, a Pre-Review Correction or a Review Response form will open. This form works similar to other forms in the system, where you navigate through the form using the Save and Continue button on the top right and the navigation pane on the left side of the page.
Responding to Stipulations
Stipulations Linked to Forms or Documents
Any stipulations added by the review board will populate within the Pre-Review Corrections form. Some stipulations may direct you to a document or form that needs to be changed.
The Description at the top of the stipulation will detail what the review board is requesting for the change.
The Stipulation Type will display either “Stipulation must be addressed,” “Comment must be addressed,” or “Comments.”
The Links to Components section of the stipulation will list the details about the linked component(s).
For each linked component, as seen above, the following fields will display:
Operations – A read-only icon used to distinguish the modification request type.
Action Status – This is the current state of the requested change as it pertains to the linked component.
Component Name – The component the link is associated to.
Action –This is the available corrective action that can be taken on the component.
Add and Remove Components
The example below details a stipulation that is request changes to the submission’s attached documents.
Note: Removing a document from a submission will not delete the document. The document will still be located in the document library for the study.
In this example, the stipulation is to add a new attachment (Study Documents, Consent forms, Sub/Attachment forms) to the Initial Review form. The view of this stipulation from the study-side of the system is shown below.
In order to respond to this request, click Add Document. This will open the following Study Document Add pop-up window.
The requested document may be uploaded here and saved to the study by clicking Save Document.
After you have added the document, the status of the stipulation action will update to Action Complete, as shown below.
If you need to view or make any other changes to the document, you may open the document using the edit/view icon in the Component Name column.
After the stipulation action is completed, you may complete the stipulation review by selecting “Yes” or “No” for the Do you accept this Stipulation?. You may also add an explanation on how you addressed the stipulation.
Revise Components – Consents and Other Study Documents
If the stipulation is requesting a change to a Consent or Other Study Document already attached to the submission, the study-side personnel will be given the ability to modify the document’s details, edit the document content, or replace with a brand-new document.
Click Revise Existing to create a new version of the attached document. Doing so will open the following Study Document Revision window, where you may modify the document details, check-out the document, and view it.
Once the details of the revised document are completed, click Save Changes to attach the new document version to the submission packet.
The original document and the current document will display in the Component Name column. The Status column will update to reflect the action is complete.
Revise Components – Study Application or Submission Forms
If the stipulation is requesting a revision to a Submission Form or a Study Application, the system will create a revision of that form and open the new version for you to make your changes.
For this operation you are given multiple options to respond to the request. You can choose to Select Already prepared or Revise Existing. The Select Already prepared action button will retrieve the study application library where you can select to attach a newer version of the application. The Revise Existing action button will allow you to create a new, editable, version of the application where the changes can be made.
The stipulation below requests modification to the Initial Review Submission Form.
Clicking Revise Existing creates a new, editable version of the Initial Review form, as shown below.
After revising and completing the form, both versions will display in the Component Name column. You can view either item by clicking on their names. The Status column will update to reflect the action is complete.
After the stipulation action is completed, you may complete the stipulation review by selecting “Yes” or “No” for the Do you accept this Stipulation?. You may also add an explanation on how you addressed the stipulation.
Submission Components
Listed below the stipulations in a Response or Correction form are the submission components.
Using this table you may view, modify, and revise components attached to the current submission. This table will also update with any revisions made to components through the stipulations.
Please note you can now view submission components from previous rounds if needed by using the dropdown highlighted in red above.
If you need to make corrections or add items to the submission that were not included in the Stipulations, you could revise the Initial Review form and make any necessary changes.
Note: This functionality is only available if the property “system.use_response_wizard_window” within System Administration > System Configuration > System Signoff and Submission Settings is set to “Yes”.
Click the icon located in the Revise/Attach column of the submission components display table.
The following confirmation window opens.
You will be asked to confirm the revision. Select the Confirm button.
You may now edit the revised Initial Review application .
Note: Once the Initial Review has been revised, the button revise icon will disappear and the unattached icon will display.
Form Creation Restriction Property
Depending on your system’s configuration, you may or may not be able to create another submission form while another is still pending in the workflow, incomplete. This behavior is controlled by a system property. Please contact your System Administrator for more details.
If this property is on, when there is a submission form that has been started with the data value to attach a study application, users will not be able to start another submission until the first submission has completed the workflow and has been fully processed.
Note: Users will not be able to start another submission even if there is no study application attached to the submission form. As long as the data vale exists in the form, uses will not be able to start a new submission form.
In the Study Management section on the study side, when the user clicks into the details of the form, in this case the Initial Submission Review Form, and the property is set to “Yes”, the option to Add a New Application Type or Delete Selected Version will not be available.
When the property is set to “No”, the buttons Add a New Application Type and Delete Selected Version will become available.
When the user clicks on the Start a Submission Form for one of My Protocols button or clicks on the Forms icon in My Studies, and the property is set to “Yes”, all submission forms with the application data value will be unavailable for use, as long as there exists an incomplete submission with that data value.
Users will receive a message stating that another form cannot be created until the form referenced has completed the workflow process.
Return the Form to the Review Board
When you are finished modifying items and responding to stipulations, and you save and continue through the rest of the Response or Correction form until it is completed.
At this point you can choose to Exit Form and return later to finish any additional corrections (if you do this, the Submission Correction task will stay on your homepage), or you can click the Signoff and Submit button to initiate the signoff. Once you complete the signoff, the Submission Correction task will be removed from your incomplete homepage tasks. The review board will receive your corrections and will further process your submission. If any additional changes are requested, the review board will return the submission for another round of changes. At that point, you would receive a new Submission Correction task and notification from the system.