Attachment 2 to RFQ-IRB System Modifications.pdf

Attachment to Performance Based Statement of Work

Task 3.6 - IRB System Modification

1. Capture and Manage Approval Contingencies

Create functionality that will capture and manage review specific approval contingencies associated with Protocol Reviews. System functionality to include the following:

a. Ability to indicate when a review approval includes contingencies (i.e. checkbox indicator).

b. Document the contingency(ies) (i.e. Navy survey approval, Command/Organizational Approval, Office of General Counsel review, et.). Request a text box to allow user to type in the contingency. Would like to track each contingency independently of the other.

c. Track dates when an individual contingency is fulfilled (possible addition of a “complete” checkbox may also be useful for email notifications and visual cue).

d. Send bi-weekly notifications (every other week) to the PI and IRB@nps.edu of reviews with remaining contingencies.

a. To: “PI”, IRB@nps.edu.

b. Subject: IRB Approval Contingencies Reminder “Tracking Number” “Protocol #”

c. Body:

Your “Tracking Number” “Protocol #”, titled, “Title” is pending the clearance of the following contingencies. As noted in your IRB approval letter research may not begin until these contingencies are cleared.

Contingency 1… Contingency 2… Contingency n…

Submit required documentation and questions regarding your review to IRB@nps.edu.

Thank you, IRB Office

d. Create a report that shows all reviews with approval contingencies fulfilled and unfulfilled. Including FY, Tracking #, Protocol Extension, PI name, Title, Contingencies, Date Fulfilled, Date Approved.

2. IRB Quick Statistics Reports – Displaying results

Add functionality that will allow the user to view reviews associated with each statistic.

a. Hyperlink review statistic to show all reviews associated with the statistic. Show the following:

FY, Tracking #, Protocol Extension, PI, Title, Application Status, Approval date, Exp Complete/Expiration or Status Report Date.

b. Allow corresponding list to be exported into excel.

3. New Report: IRB Non-Exempt-ALL mailto:IRB@nps.edu

Attachment to Performance Based Statement of Work

Task 3.6 - IRB System Modification

Create a new report that displays information for reviews with a risk level of “minimal” and “more than minimal.”

a. Report the following fields: FY, Tracking #, Protocol Extension, PI, Title, Approval date, Application Status, Exp Complete/Expiration Date.

b. Include filters: (FY, PI, approval date, expiration date, department, command).

c. Allow export of report into excel.

4. Document Additional Researchers in Determination Reviews

Allow users to document additional members of the research team when entering determination reviews.

a. Activate “Other Researcher” tab when a determination is being entered.

b. Allow “Find a Record” function to search “Other Researchers” when searching for determination reviews.