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COMPLETE AND PRINT FORM Page 1 of 2 REVISED: June 2010 RESEARCH ETHICS OFFICE Center FOR ADDICTION AND MENTAL HEALTH PROTOCOL DEVIATION REPORTING FORM Protocol deviations that lead to an SAE should

How to fill out protocol deviation reporting form

How to fill out protocol deviation reporting form?

1. Start by entering the relevant details, such as the study title, protocol number, and investigator name. This information helps identify the specific study for which the deviation is being reported.
2. Provide a clear description of the protocol deviation. Include the date and time it occurred, as well as any relevant details about the deviation itself. Be precise and concise in describing the specific deviation that occurred.
3. Specify the impact of the deviation on the study. Assess whether it had any effect on subject safety, data integrity, or study objectives. This information helps the responsible parties properly evaluate the deviation and take appropriate actions.
4. Identify any actions taken to address the protocol deviation. Describe any corrective or preventive measures implemented to minimize the impact of the deviation. This demonstrates the proactive approach taken to rectify the situation.
5. If applicable, indicate whether the protocol deviation was reported to the relevant regulatory authorities or ethics committees. Depending on the nature and severity of the deviation, it may be necessary to notify these governing bodies to ensure compliance and oversight.

Who needs protocol deviation reporting form?

1. Researchers conducting clinical trials or studies involving human subjects.
2. Investigative sites and study personnel responsible for monitoring and ensuring protocol adherence.
3. Regulatory authorities and ethics committees overseeing the study to maintain data integrity and subject safety.

For pdfFiller’s FAQs

What is protocol deviation reporting form?

Protocol deviation reporting form is a document used to report any deviations from the approved protocol during a research study.

Who is required to file protocol deviation reporting form?

The principal investigator or any member of the research team is required to file protocol deviation reporting form.

How to fill out protocol deviation reporting form?

Protocol deviation reporting form should be filled out with details of the deviation, including the date, nature of the deviation, impact on the study, and any corrective actions taken.

What is the purpose of protocol deviation reporting form?

The purpose of protocol deviation reporting form is to document and track any deviations from the approved protocol to ensure study integrity and participant safety.

What information must be reported on protocol deviation reporting form?

Information such as date of deviation, description of deviation, impact on study, corrective actions taken, and any follow-up required must be reported on protocol deviation reporting form.

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