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CONSENT FORM VERSIONING GUIDANCE DOCUMENTQuorum Review works with the Sponsor/CRO contacts on central studies and Site contacts on single site studies to develop a consent form that meets all regulatory
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Consent form versioning guidance is a set of instructions on how to manage and track different versions of consent forms used in research studies.
Researchers conducting studies that involve human subjects are required to file consent form versioning guidance.
Consent form versioning guidance can be filled out by following the instructions provided by the Institutional Review Board (IRB) or the research ethics committee.
The purpose of consent form versioning guidance is to ensure that participants are aware of any changes made to the consent form during the course of the study.
The information that must be reported on consent form versioning guidance includes the date of each version, the changes made, and the reason for the changes.
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