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APPENDIX D: PROTOCOL DEVIATION OR VIOLATION REPORTING FORMVersion Number 5.0Effective Date: 4 November 2019Supersedes Version Number 4.0 dated 3 September 2009Title of Proposal:Principal Investigator(s)SERU/SSC/NONSSC
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How to fill out protocol deviation or violation

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How to fill out protocol deviation or violation

01
Identify the protocol deviation or violation that occurred.
02
Document the relevant details such as date, time, location, individuals involved, and nature of the deviation or violation.
03
Notify the appropriate parties such as the principal investigator and institutional review board (IRB).
04
Evaluate the impact of the deviation or violation on the study.
05
Implement corrective actions to prevent recurrence.
06
Update the study documentation accordingly.

Who needs protocol deviation or violation?

01
Individuals involved in clinical trials or research studies such as researchers, study coordinators, and sponsors.
02
Institutional review boards (IRBs) overseeing the conduct of research studies.

What is protocol deviation or violation reporting Form?

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Template protocol deviation or violation reporting instructions

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A protocol deviation or violation refers to any instance where a study is not conducted according to the approved protocol, which may result in discrepancies in data collection or research outcomes.
The principal investigator and the research team members involved in the study are typically required to file a protocol deviation or violation.
To fill out a protocol deviation or violation, you would typically complete a standard reporting form that includes details of the deviation, its impact on the study, and corrective actions taken.
The purpose of reporting protocol deviations or violations is to ensure transparency, maintain data integrity, and comply with regulatory requirements.
Information that must be reported includes the nature of the deviation, date it occurred, the reason for the deviation, impact on the study, and measures taken to address it.
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