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Protocol DeviationsEffective date: 16/08/2012 SOP 12/V3Page 1 of 8Committee for Academic Research Ethics (CARE) Seth G.S. Medical College and K.E.M. Hospitality:Protocol Deviation/Non Compliance/Violation

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03

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04

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05

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Who needs protocol deviationnon?

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What is protocol deviation?

Protocol deviation is any divergence from the approved protocol during the conduct of a research study.

Who is required to file protocol deviation?

Investigators and research personnel are required to promptly report protocol deviations to the institutional review board (IRB) or ethics committee.

How to fill out protocol deviation?

Protocol deviations should be documented using a specific form provided by the institution or sponsor, and include details such as the nature of the deviation, date of occurrence, potential impact on subject safety and data integrity, and proposed corrective actions.

What is the purpose of protocol deviation?

The purpose of reporting protocol deviations is to ensure the safety of research subjects, maintain data integrity, and adhere to regulatory requirements.

What information must be reported on protocol deviation?

Information to be reported on protocol deviation includes the nature of the deviation, date of occurrence, potential impact on subject safety and data integrity, and proposed corrective actions.

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