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PPM IRB Protocol Deviation Report Form (revised March 2016). Page 1 of 5. INSTITUTIONAL REVIEW BOARD. Protocol Deviation Report. Principal ...

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What is protocol deviation report form?

The protocol deviation report form is a document used to report any deviations from the approved research protocol during a clinical trial.

Who is required to file protocol deviation report form?

Investigators, sponsors, and research institutions are required to file the protocol deviation report form.

How to fill out protocol deviation report form?

The protocol deviation report form should be filled out by providing details of the deviation, including the date, nature of the deviation, impact on subjects, and actions taken.

What is the purpose of protocol deviation report form?

The purpose of the protocol deviation report form is to ensure transparency and documentation of any deviations that occur during a clinical trial.

What information must be reported on protocol deviation report form?

The protocol deviation report form should include details such as the date of deviation, nature of deviation, impact on subjects, actions taken, and any corrective measures implemented.

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