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  4. Keeping it simple when drafting contingencies

Keeping it simple when drafting contingencies

Keeping contingencies as clear and to-the-point as possible will simplify discussion of them in the meetings and the PI’s ability to respond to them. Please limit contingencies to a single concept or requirement whenever possible. Embedding multiple requirements or requests for information into a single contingency can lead to the PI overlooking one of the many items listed, which in turn means the contingency has to be considered “not met” when the response is reviewed.

One exception to the “one topic per contingency” standard is that multiple requested grammatical corrections to a single document can be combined into a single contingency. However, when requesting grammatical changes, please keep the criteria for approval in mind. Minor grammatical corrections may not be appropriate contingency fodder when the corrections do not relate to the criteria for approval. Items that don’t address these criteria can be included in a “note” in CLARA rather than a contingency. “Notes” are informational items the PI can refer to when next revising a study and don’t require a response in the current review. You can also use the “note” function to add information that you’d like to document for other reviewers, but that you don’t necessarily want to include in any IRB letters to the PI, or for which you don’t need a response to the study team.

Posted by Edith Paal on October 1, 2014

Filed Under: Institutional Review Board Members

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