Pending Applications

 

On the Pending Applications page, if a user has the ability to access several records, Insight may require that the user hits the ‘Search’ key, and preferably limit the search by entering search criteria before doing so.  No search results will display until the search is performed.  This rule applies to users who have been granted access to data through the Insight Admin module with the following conditions:

 

  1. User has access to more than five Principal Investigator’s portfolios OR

  2. User has access to more than one Organization

 

 

The Pending Applications page displays applications (Initial Reviews, Continuing Reviews, Amendments, Adverse Events and Other Events) that have been submitted to the IRB, but have not yet been approved.  The overall status of these applications will be either ‘Submitted’ or ‘Pending’:

 

There is an icon in the ‘Lock Status’ column which indicates the current state of the protocol process.

 - Protocol process is locked and cannot be edited.

  - Protocol process is unlocked and can be edited.

 

Search results can be filtered by Principal Investigator (PI), Organization (ORG), or any of the page specific search criteria (Protocol # and Title).  Additional search criteria fields can be found by clicking the ‘Advanced Search Options’ link.

 

Based on the selection criteria and security access, the applications are filtered and displayed.  All information displayed on this page is read only and, therefore, cannot be modified.  The following

 

columns appear in the search results grid; Protocol #, PI Name, Title, Sponsor Name, Forms ID, Date Received, Board, Review Type, Meeting Date, Review Status, Lock Status, Review Notes and Workflow History.  All columns, except Lock Status, Review Notes and Workflow History can be sorted by clicking on the column header title link. 

 

The arrow indicates the screen is sorted to that column in either ascending (up) or descending (down) order.  The default sort order of the data is descending order.  The text for Title and Sponsor Name has been limited on the screen for display purposes, but the entire contents can be viewed by placing the cursor over the field.  The Title is a link which, if selected, navigates the user further into the record.  For any records that have a status of ‘Submitted’, the Forms page will appear.  For any records that have a status of ‘Pending’, the Protocol Details page will appear.  These records have been assigned protocol numbers and have associated details.

 

The page displays 20 records per page.  If a user has access to more than 20 records, the paging links located at the top right or bottom right of the grid (First Page | Previous Page | Next Page | Last Page) will allow the user to scroll through all records.

 

Information can be downloaded by clicking on the ‘Download to Excel’ link or the ‘Download to PDF’ link located on the page title bar.

 

Screenshot with Expanded Search option:

 

 

Main Screen Elements

Column Name

Description

Protocol #

A unique number assigned by Research Express for tracking the protocol.  This number will remain throughout the entire lifecycle of the protocol.  The Protocol # will be blank on this page for any new protocol that is still in a ‘Submitted’ status.  The Protocol # is assigned when the protocol reaches the Humans Research Office (HRO) and moves to a ‘Pending’ status.

PI Name

The name of the Principal Investigator staffed to the protocol (in format Last Name, First Name).

Title

The title of the protocol.

Sponsor Name

The name of the sponsor.

Forms ID

A unique ID assigned to the submission process.  For example, new protocols are assigned IR for Initial Review, Continuing Reviews are given a name and sequenced number identifier, i.e. CR3, and Amendments are given a name and sequenced number identifier, i.e. AME1.

Date Received

The date the protocol was received by the Humans Research Office through workflow.

Board

The name of the board that has/will be reviewing the protocol.

Review Type

The type of review, i.e. Full or Expedited.

Meeting Date

The date the submission will be reviewed.

Review Status

The resulting status of the board review, i.e. Req. Mod.

Lock Status

A visual cue to show if the protocol is locked or unlocked.  An unlocked protocol record can be modified by anyone associated to the study with Edit or Manage privileges.

Review Notes

Displays any notes from the review as a WordPad file.  Click on the notes icon to display the contents of the file.

Workflow History

Displays the workflow steps for the process including departmental and study staff sign-off.  Click on the workflow icon to display the contents of the file.

Locking / Unlocking

When an application is initially submitted, the application is unlocked and assigned a status of ‘Submitted’.   During this time, the application is awaiting critical study staff sign-off.  If any critical study-staff decline the application, the submitter will be able to edit the protocol in its unlocked state.  After the critical participants have accepted the application, the status switches to “Pending” and the application is locked.  At this point the administrators can begin working to get the protocol through to final approval.

 

An application is locked and unlocked as it progresses through workflow.  However, when a process is in a locked state and is “Pending”, it can also be manually unlocked by protocol administrators upon request when necessary.  This is done on an exception basis.  When an application is locked, it is locked for everyone.  The allowance of designated users to override the lock status of a given application, based on its sequence in workflow, helps the business to adapt to situations that might not be fully anticipated by the automated business rules.

 

Note:  The capability of locking and unlocking is available to specific end-users through the Admin module.

 

Screenshot showing the Unlock button:

 

Screenshot showing the Lock button:

 

Versioning

The ability to track activity on an application in workflow is critical to ensuring its quality during preparation.  While reviewers are ultimately responsible for approving an application, keeping control over changes is very important to ensure that everyone involved is approving the same application and not a constantly changing one.  For example, when the application is being scheduled for a board review meeting, it is locked.  At that time it is necessary to version the application in order to have a record of what the state of the application before it was unlocked and modified.  Once an application is locked for the first time, it becomes the official first version of the application.  If the application is unlocked after that, new versions of the application are created.  Once a change has been made, one cannot revert back to an older version.  Explicit locking for administrative users is critical for this reason.