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Protocol Deviation Report Form Joint CUHK-NTEC Clinical Research Ethics Committee Protocol Deviation: A protocol deviation is any change, divergence, or departure from the study design or procedures

How to fill out protocol deviation report form

How to fill out a protocol deviation report form:

1. Begin by ensuring you have the correct form. The protocol deviation report form can usually be obtained from your institution or organization's research compliance office.
2. Start by providing basic information about the study. This typically includes the study title, principal investigator's name, study sponsor, and protocol number.
3. Indicate the date and time of the deviation. Specify when the deviation occurred and if it is a single event or ongoing.
4. Describe the deviation in detail. Clearly explain what happened, why it deviated from the protocol, and what potential impact it may have on the study.
5. Provide any relevant supporting documentation. Attach any documents such as emails, memos, or data that support your report of the deviation.
6. Assess the severity of the deviation. Determine the level of risk or impact to the study based on predefined categories provided on the form.
7. Offer potential solutions or corrective actions. Suggest ways to mitigate the deviation or prevent similar incidents from occurring in the future.
8. Sign and date the form. Confirm your acknowledgement and submission of the report by signing and dating it.
9. Submit the completed form. Follow the designated procedures for submitting the protocol deviation report form to the appropriate person or department responsible for review and investigation.

Who needs a protocol deviation report form?

1. Researchers conducting clinical trials or other types of studies involving human subjects often need a protocol deviation report form.
2. Institutional review boards (IRBs) or ethics committees that oversee research may require researchers to submit protocol deviation reports.
3. Sponsors or funding agencies supporting the study may request protocol deviation reports to ensure compliance with the approved protocol and regulations.
4. Research compliance offices in institutions or organizations may use protocol deviation reports to monitor and address deviations from approved protocols.

For pdfFiller’s FAQs

What is protocol deviation report form?

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

Who is required to file protocol deviation report form?

The Principal Investigator and the study team 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, the impact on the study, actions taken, and any corrective measures.

What is the purpose of protocol deviation report form?

The purpose of the protocol deviation report form is to document and report any deviations from the study protocol to ensure data integrity and patient safety.

What information must be reported on protocol deviation report form?

The protocol deviation report form must include details of the deviation, its impact on the study, actions taken, and any corrective measures.

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