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  4. Study progress details greatly appreciated on Continuing Review forms

Study progress details greatly appreciated on Continuing Review forms

Continuing review forms include a query asking you to summarize study progress in a free-text response. Please use this space to provide a complete summary of the study’s status, including describing how many subjects have completed the study, what part of the study any that haven’t completed yet are in, whether any notable positive or negative issues were noted to date, etc. We’ve seen responses such as “enrollment is ongoing although recruitment has been slow,” which doesn’t tell the IRB much about the experience of previously enrolled subjects. In doing a continuing review, the IRB is required to determine whether any factors related to the criteria for approval have changed so much that the board needs to reconsider its initial approval determinations. The more information you can provide about current study status, the easier it is for the IRB to consider any determinations in may need to make.

Posted by Edith Paal on November 6, 2018

Filed Under: Institutional Review Board Members

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