Important RAMS-IRB Patch Announcement
An update to the RAMS-IRB system is tentatively scheduled to occur between 7/23/2018 and 8/3/2018. Two of the items in this system patch will affect investigators:
- PI Action reminders will be sent to investigators and study editors every 3 days instead of every 30 days.
What are PI Action reminders? PI Action reminders are automatically sent by RAMS-IRB whenever submissions are sent back to study teams so that changes can be made. The reminder schedule is not controlled by the IRB staff.
Why is this change being made? This change is being made in order to aid study teams in knowing which submissions need attention.
What impact will this change have on investigators? Data shows that 71% of all submissions are returned to the IRB within 14 days, so most study teams are likely to receive only 0-4 reminder emails. However, study teams could receive up to 20 reminders before the submission auto-withdraws. Investigators could begin receiving reminders 3 days after the RAMS-IRB patch occurs.
- Submissions will auto-withdraw after 60 days instead of after 90 days.
What is auto-withdrawal? RAMS-IRB is designed to automatically withdraw submissions that have not been returned to the IRB within 60 days. This 60-day time period can be calculated as follows: [Date changes were requested by the IRB] + 60 calendar days. IRB staff do not have the ability to manually control these automatic withdrawals.
Why is this change being made? This change is being made in order to maximize the efficiency of the IRB’s processes.
What impact will this change have on investigators? Data shows that 93% of submissions are returned to the IRB in less than 60 days, so this change is anticipated to have a little or no impact on most study teams who respond in a timely manner to IRB requests for changes.
Submissions that are in a PI Action state on the day that RAMS-IRB is updated could auto-withdraw sooner than the study team was anticipating. The IRB will be individually contacting study teams whose submissions are have been in a PI Action state for more than 20 days to let them know what their new resubmission timeline is.
What can I do to avoid having my submission auto-withdrawn? The only way to prevent a submission from being auto-withdrawn is to resubmit it to the IRB. Study teams that need more than 60 days to make changes have the option to resubmit the submission back to the IRB with a comment that explains that more time is needed to address some of the changes. The IRB would then return the submission to the study team, and this would “reset the clock” to give study teams another 60 day window to work on the changes.
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