Well, we can’t promise to make contingencies go away altogether, but you know what they say — Happy IRB office staffers/reviewers write fewer contingencies. Here are a few tips to keep the IRB happier and contingencies at bay:
- When you’re notifying the IRB of a temporary study closure of any kind, e.g. closure to enrollment only, or the entire study being put on hold, please include a description of the status of any current on-study subjects. How many are there? Will the reasons for the closure have any impact on current subjects’ treatment or need for reconsenting? Please let us know up front.
- In staff modifications, please include the names of staffers being removed or added in the free text you write in response to the “what is being changed” query. That information prevents the IRB office from having to dig through old submissions to figure out which staffing elements have changed.
- In Continuing Review forms, when you refer to previously reported study events or deviations, please let us know the date those events were reported to the IRB. That prevents us from having to dig through the entire CLARA file to find any previous reports.