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Does the PI and/or study coordinator need to be present during the entire review?

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Does the PI and/or study coordinator need to be present during the entire review?

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No. However, before the QI staff begins a review of study documentation we ask to meet with the PI and/or study coordinator to discuss the conduct of the study. The QI staff will make arrangements to meet with the PI and/or study coordinator after the review for further discussion, feedback and debriefing. The PI may delegate the study coordinator to meet with QI.

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