In the IRB’s continued efforts to streamline the IRB review process, the previously announced automated withdrawal & closure function in WRG-HS will soon be launched. Beginning the evening of June 30th, inactive submissions and applications will be auto-withdrawn or auto-closed, depending on the set of criteria detailed below.
Specifics on the update include:
1. Six new WRG statuses:
- Expired: Notes studies that have lapsed in approval.
- Withdrawn - PAM Required: Notes withdrawals warranting Post Approval Monitoring (PAM) submission in its place.
- Withdrawn - CR required: Notes withdrawals warranting a Continuing Review (CR) submission in its place.
- Withdrawn - Abandoned submission: Notes withdrawals due to inactivity for an extended period.
- Withdrawn – Study Team Request: Notes withdrawals made at the request of the study team.
- Withdrawn - Multiple open submissions: Notes withdrawal of duplicate submissions or when simultaneous submissions are being submitted/under review.
2. Administrative closure of expired submissions:
- 90 days after being designated as "expired", WRG will auto-close studies that have been expired
- The study team will be alerted with a notification of imminent auto-closure two weeks before the submission is closed.
- Once a record is Closed, an automatic notification will be released to the study team informing them of the study’s closure.
3. Administrative withdrawal of outdated/inactive submissions:
- Submissions that have been created but have not been submitted for 90 days will be auto withdrawn.
- Submissions that have been reviewed and returned to the study team by the IRB with no response for 90 days will be auto withdrawn.
Since there are hundreds of abandoned submissions in WRG that have been created over the past three years, when the script is first launched the evening of June 30th, all impacted submissions and expired studies will not receive notification. All subsequent impacted studies will be notified in advance of any applicable automated action.
We will be running Q&A sessions on these updates in the coming weeks – information about these sessions will follow. Also, FAQs on these updates will be added to the WCM IRB website.
For questions, please contact the WCM IRB at firstname.lastname@example.org.
The IRB thanks you for your help throughout our continuing improvement efforts.