Click IRB Upgrade
The Click application encompassing Institutional Review Board (IRB), Conflict of Interest (COI), Institutional Animal Care and Use Committee (IACUC) and Grants and Agreements will be upgraded on December 11 to increase functionality and integration and improve stability and performance.
The Click system will be unavailable beginning 5 p.m. Pacific time on December 1 until December 11.
Calls to action to prepare for downtime
- Before December 1, study teams who use Click IRB as their source for current versions of study documents (e.g., consents, protocols, etc.) need to download all the current versions of study documents they may need during the planned downtime in both PDF and Word formats for ease of use (e.g., with participants or for drafting/editing purposes).
- Study teams should consider rescheduling any study monitoring/inspection visits scheduled during this downtime period.
- IRB studies with a “last day of the approval period” falling within the Click downtime should submit a Continuing Review as soon as possible to avoid having a study approval lapse. If IRB approval expires, all procedures must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions and collection or analysis of private identifiable information. Continuing procedures during a lapse is a violation of institutional policy.
- The week of November 27, items in the “pre-submission” state for more than 365 days will be discarded. This includes new studies (internal and external), modifications and continuing reviews. To avoid the discard of a submission, ensure it is ready and submit it for review.
- During the downtime, the IRB office will need to limit the types of submissions accepted for review to those related to time-sensitive participant/patient needs. Examples include emergency/compassionate uses and submissions involving time-sensitive risks. Any such submission will need to be emailed to the IRB along with the reason the submission needs to be reviewed during the downtime. Study teams need to carefully plan and coordinate the timing of their submissions as a result.
- Reportable New Information (RNI) submissions are required to be submitted to the IRB within five business days of learning of the new information. Due to the downtime, the IRB will waive the five-business-day requirement for the week of December 4. Affected RNIs must be submitted at the next opportunity after the downtime.
- During the downtime, the IRB office will be following contingency plans in order to conduct some submission reviews. However, there will be very limited IRB submission review correspondence to study teams during downtime. The primary reasons include: the Click application is our official regulatory record; required upgrade procedures; and the IRB office will have multiple responsibilities related to the upgrade that week.
Post-upgrade process changes
External IRB studies
Most changes in IRB are cosmetic apart from the External IRB workflow. In the upgrade, external IRB studies will be classified as multi-site with one integrated SmartForm recording information. Two categories of changes can be made to studies: modifications or updating study details. Study teams will still need to keep their approval dates current, but the process for doing so will change. A detailed reference guide will be available soon to assist you with these changes.
Items in "Pre-Submission" state
In the upgrade, items remained in the "pre-submission" state for more than 365 days will be regularly discarded to avoid having open submissions that never enter the IRB review queue. Items in the "pre-submission" state should be visible in “My Inbox” or on the “In-Review” tab in Click IRB. To avoid the discard of a submission, ensure it is ready and submit it for review in a timely manner.
New required continuing review progress report template
Effective January 15, 2024, study teams will be required to complete and submit a new continuing review (CR) progress report template at CR submission. The progress report template collects a brief summary of research progress, explanations of research milestones, clarifications about information provided in the CR SmartForm, consent requirements for participants who have reached the age of majority and further information if the study has lapsed.