Please note: A PDF version of this guide is available for download at the bottom of the article.

Study records in iRIS™ are comprised of two primary sections: Submissions and Study Management. Using these features both review board members and key study personnel can view and manage important study information. Additional sections may be available depending on your institution’s configuration, such as Animal Management, Subject Management, Post Award Management, etc.

The Study Management section enables access to many study items such as sponsors and subrecipients, drugs/devices/agents, enrollment criteria, the COI status of key personnel, and more.

This manual will provide a general overview of the tools available within this Study Management tab.

Accessing a Study

To view the Study Management tab, you must first open a study. One method to do this is to click the View and Manage My Studies button in the “Featured Study Operations” panel on the Study Assistant homepage. This will anchor the page down to the “My Studies” panel, displaying all studies that are associated to the logged in-user.

Click the icon to open a study record.

By default, opening a study will redirect to the “Submissions” tab, as shown below.

For more information on the “Submissions” tab, see the Study Assistant – Submissions manual.

Study Information Header

Displayed at the top of every study record is an information header, an example of which is shown below.

The upper row of the header contains the Study Number and PI name. The example above is an IRB study, so the IRB Number is displayed.

Below this is the Study Status, Study Number, Review Board Expiration Date (if it exists), and Study Title.

The information in the header will update dynamically as changes to the study occur.

Study Management

Navigate to the Study Management section by clicking the “Study Management” tab.

Study Management contains study-specific information primarily originating from the initial study application. Certain data values included in the application form connect directly to the links on the Study Management page (see the Study Assistant – Add a Study manual for more information).

Study Details

The first section in Study Management is Study Details. Study Details contains links to different study core fields such as study summary information as set by the review board, personnel screen access, personnel on the study, and departments on the study.

Study Summary/Profile

The Study Summary will display the current status information related to the study. Any review board updates to these fields will be reflected here.

This page is broken up into several sections. The first section displays basic study information and may appear differently in your system, depending on your system configuration. Always displayed are the Study Title, Status, and Study Number. The Status field is the current Study Status.

The additional sections provide more specific study information. These may be expanded or collapsed by clicking on the or the icons.

You can also open a view of this page to print out for your records by clicking on the Print Friendly button.

Study Departments

The first section of the Study Summary lists current departments associated to the study (as defined in section 3.0 of the Study Application).

Study Personnel

Study Personnel displays the names and roles of the current Study Personnel that are associated with the study (as defined in section 2.0 of the Study Application).  

A user’s profile can be viewed by clicking on the icon next to their name. This opens the User Information pop-up window shown below.

This window will list contact information as defined in the user’s account, training records defined under the Education History group, and any Medical Licenses and CVs uploaded.

Close this window to return to the Study Summary page.

Review Boards

All review boards associated with the study that have reviewed the submission in question will be displayed as a section on the Study Summary page. These sections contain important review board attributes and study information such as approval dates, expiration dates, closure information, the risk assigned to the study, and more. Infomration that is updated by the review board will be updated on this page as well.

Depending on system settings, and teh review boards that are associated to the study, the information that displays on this page may differ.

If more than one review board is associated to the study, each review board is listed separately in different groups. In the example above, only one review board, IRB, has been assigned to this study, so only this section appears on the Study Summary screen.

Study Details

This area of the Study Summary will provide an overview of other items in the study record such as Sponsors, Drugs, Devices, and Enrollment Criteria. If information has been associated to the study in any of these groups, they will display in this area along with any accompanying details.

Sponsors on the study will display in this section. You can click on the Sponsor link to obtain additional information.

Study Drugs and Devices will also display, along with the details for each item on the study. You can click on the link for either Study Drug/Biologic/Chemical agents or Study Devices for additional information.

This Study Details section also displays any Inclusion or Exclusion Criteria added to the study with clickable links for additional details.

When you are finished viewing the Study Summary, click the Back button to return to the Study Management tab.

Screen Access

Screen Access enables users to customize access to study screens for certain KSP. By default, if a user is assigned a role on the study, their study access will be determined by the Study Role Access configuration within System Administration (see the System Administration – System Setup manual for more information). This “Screen Access” page allows users to further customize the areas of a study that KSP have access to.

The leftmost column of this table lists all available screens for this specific study. The columns on the right correspond to each KSP on the study. Within each user column are checkboxes that represent whether or not that user can access a particular screen.

There are two checkboxes for each user/screen combination: “Read” and “Write”. Checking “Read” give the user read-only access to that screen, while checking both “Read” and “Write” gives the user full read/write screen access.

Depending on the number of users on the study, vertical and horizontal scroll bars may display so you can view roles and screens that may extend beyond the boundaries of the browser window.

After making the desired changes to this screen, click the Save Changes button and then the Back button to return to the main Study Management screen.

Key Personnel

This link will open a screen similar to the one found in Section 3.0 of the Study Application. Listed on this page is all current personnel on the study. In order for this study record to display in a user’s My Studies panel on the Study Assistant homepage, they must be listed as Key Study Personnel here.

Your system may or may not display all the roles shown below, depending on how your system is configured.

Depending on the Study Status, this page may be locked to any changes in personnel. In this case, any KSP modifications must be submitted to the review board for approval. See the Submissions manual for information on submitting change requests.

If the Study Status allows for Personnel changes, the page will not be locked, and you will be able to add and remove users from the Study, as shown in the screen below.

You may also be able to add and modify responsibilities for users and view/manage KSP training records depending on your role settings.

To add an additional user to this study, click the Setup Study Personnel at the top of the page then you can find the user or search the directory to add the user to the corresponding role, as seen in the image below.

The Setup Study Personnel window allows you to search the user directory by First Name, Last Name, or Department. Enter all or part of the criteria and click the Find User/Search Directory button.

To select a user to add, click the icon. This opens the Add to Personnel Role window, where you can assign a role to the user.

Select a role and then click the Save button. Once saved, the system will return to the Setup Study Personnel window where the newly added user has populated in the personnel table.

You may or may not see the same role options as presented in this document, depending on your system configuration.

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.

Administrative Assistants – If you would like to give an administrative assistant access to the study for data entry purposes, you can assign them this role. Any number of Administrative Assistants may be added. These users typically have limited access to the study, will not be considered KSP in the education check, and will not be included in the submission signoff process. As this role is not considered KSP, you may add users to this role without review board approval.

You may remove a user from the study by clicking the delete icon next to their name. If removing the Principal Investigator, you must also select a replacement, as no study record in iRIS™ can be missing a PI. Note that if the study’s status is such that personnel modifications are locked, a KSP change form must be sent to the review board for approval.

To complete the changes to the “Define Study Access” screen, click the Save Access to the Study button and then click Back to return to the main Study Management screen.

Department Access

The Department Access link opens the “Study Department Access” page, which displays all departments that have been associated to the study. This information is pulled from section 2.0 of the Study Shell in the study application form.

The Primary column in the department display table shown above enables you to designate a department as “Primary”. As this is a radio button field, only one department may be elected the primary department. If any changes are made to this designation, a Save Access button will appear on the screen. Click this to save your changes to the study department access and click Back to return to the main Study Management screen.

Changes to the departments themselves must be performed either in the study application or by submitting a change form to the review board, depending on the current status of the study.

Study Tasks

Study Notebook

The Study Notebook is used to collect and maintain study documentation. This documentation may include internal notes between study personnel or generated correspondence.

The Study Notebook for a new study will by default be empty, as shown below.

Click Add a New Note to create a new note for this study. This will open the following page.

Enter a Subject (required), Occurrence Date (required), and Content for the note. Note that the Content field is not required in order to create the note.

A document may be attached to the note by clicking the Upload Document(s) dashed box or directly dragging in a file.

If you choose not to select Use Correspondence with this Note, you may save and add this new note to the Study Notebook ledger by clicking the Save Note button. This note will be visible to any user with access to the Study Notebook.

If you instead choose to send correspondence with this note, select “Yes” for the Use Correspondence with this Note field.

Doing so will present a list of options allowing you to customize the correspondence. Each field is discussed below:

• Send Email with Correspondence – Choosing “Yes” means that an email will be generated with this note and sent to the selected recipients. Indicating “No” means that the Correspondence will be sent through iRIS™ only.
• Start Date for Correspondence – The date that the correspondence will generate. This can either be a calendar date or a number of days after the occurrence date.
• Send Correspondence – The frequency that the Correspondence will be sent.
• Complete – Choosing “Yes” marks the Correspondence configuration as completes and generates the message according to the options defined above. The default selection is “No”, meaning that the Correspondence is considered incomplete and will not generate upon saving the note.
• Recipients – This is a clickable link that will open a page listing all current Study Personnel, as seen in the image below. If the Study Application has been submitted, members of the review board overseeing your study will be listed as well. After selecting who will receive the correspondence, click the Save Changes button.

• Additional Recipients – This is a clickable link that will open the “Correspondence Additional Contacts” page. Here you may add a contact to the Correspondence that does not have an account in iRIS™. To do this, click on the Add a New Contact button.

Doing so will open the following page.

Here you may assign the new contact a name and email address. Using the Add a New Contact and Remove Selected Contacts buttons you may add or remove additional recipients to your liking. Once finished, click the Save and Return button to add the new contacts to the Correspondence.

Once all note fields have completed you may save the note record by clicking Save Note.

The new note will now populate in the Study Notebook. At any time, you can view this note or generate additional notes for the study. Click the Back button to return to the main Study Management screen.

Sponsors & Subrecipients

Sponsor

Clicking the Sponsor link shown above opens the “Study Sponsor” page.

All sponsors that were added to this study through data values in the Study Application Form will display here. The sponsors are divided into two groups: approved sponsors and sponsors that are pending approval. Modifications to this sponsor configuration require submitting an Amendment form to the review board.

Sponsors that populate in the Approved Sponsor section are associated to a submission that has been approved by a review board. Changes to these sponsors must be submitted to board for approval.

Sponsors populate in the Pending Approval section whenever a sponsor modification request is in the process of being approved by the review board.

View the details of a sponsor by clicking on the icon in the Open column. This will open a page displaying a read-only printout of the sponsor information, as shown below.

Click the Contacts link on the left side of the screen to view or add sponsor contacts.

Click Add Contact to open a list of contacts associated with the sponsor.

Check the box next to one or more contacts and click Add selected Contacts to add the sponsor contact to the study or click Add a new Contact to create a new contact for the sponsor.

Enter the contact’s information and click Save Changes to add them to the study. This will also add the new contact to the master contact list associated with the sponsor.  

Click Back to return to the list of sponsor contacts on the study. If you added a contact in error, click the checkbox next to the contact name and click Delete Contact. Click Go Back to return to the main Study Sponsor screen.

Drugs and Devices

Drug/Biologic/Chemical Agents

Clicking this link opens a page listing all drugs that were added to the study through the Study Application data value. These are broken up into two parts, Approved Drugs and Pending Drugs, as seen in the image below.

Drugs populate in the Approved Drugs section when the review board approves a submission to which the drug is associated. Once a drug becomes approved, any modifications to that drug must be submitted to the review board for approval.

Drugs populate in the Pending Drugs section whenever a modification to an existing drug is requested, or a new drug is in the process of being approved by the review board.

You can view this page in a print friendly format by clicking the Print Friendly button on the top right of the page.

View a drug’s details by clicking on the icon in the Open column.

This will open a read-only printout of the drug information.

Devices

Click this link to view all devices that have been added to the study via the Study Application Form data value. These devices are divided into two categories, Approved Devices and Pending Approval, as seen in the image below.

Devices populate in the Approved Devices section when the review board approves a submission to which the device is associated. Once a device is approved, any modifications to that device must be submitted to the review board for approval.

Devices populate in the Pending Approval section whenever a modification to an existing device is requested, or a new device is in the process of being approved by the review board.

You can view this page in a print-friendly format by clicking the Print Friendly button on the upper right corner of the page.

You can view device details by clicking on the icon in the Open column.

This will open a read-only printout of the device information.

Pending request tables improvements

A modification has been made to the “Pending Request” tables that affects drugs, devices, species, analgesia, strain etc. In previous versions of iRIS™, the above items would populate in the “Pending” table as soon as they were added to the Study Application via the respective data values.

This modification prevents these items from populating in the “Pending” table until the study no longer has a status of “Draft”. That is, the study must be submitted to a review board before the drugs, devices, etc. defined in the Study Application Form are displayed as “Pending”. This applies to any form that contains associated drugs, devices, and species, i.e. Amendment and Correction forms as well.

Once the submission has been sent to the review board and the “Draft” status is changed, the items will populate in their respective “Pending” tables.

Once the submission is approved, the items will then move into the “Approved Drugs” table.

If a study revision is created, the original data will not be saved and thus not populate in the “Pending” tables .

Enrollment Criteria

Inclusion Criteria and Exclusion Criteria

These two links provide access to the Inclusion and Exclusion Criteria entered in a study’s application form. The information below applies to both types of criteria, and Inclusion Criteria is used as an example.

Clicking the “Inclusion Criteria” link opens the following page.

This page is broken up into two sections, Approved Criteria and Pending Approval.

Criteria populate in the Approved Criteria section when the review board approves a submission to which the criteria is associated. Once approved, any modifications to these criteria must be submitted to the review board for approval.

Criteria will populate in the Pending Approval section whenever a modification to an existing criteria record is requested, or new criteria are in the process of being approved by the review board.

You can view this page in a print-friendly format by clicking the Print Friendly button on the upper right corner of the page.

You can view criteria details by clicking on the icon in the Open column, which will open a read-only printout of the criteria information.