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Institutional Handbook of Operating Procedures
Policy 09.13.39
Section: ClinicalResponsible Vice President: MVP and CEO Health SystemSubject: General Clinical Procedures and Irresponsible Entity:
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What is subject general clinical procedures?
Subject general clinical procedures refer to the standard operating procedures and guidelines followed during clinical trials to ensure the safety and integrity of the study.
Who is required to file subject general clinical procedures?
The sponsor or principal investigator of the clinical trial is responsible for filing subject general clinical procedures.
How to fill out subject general clinical procedures?
Subject general clinical procedures should be filled out according to the specific guidelines and requirements set by the regulatory authorities and institutional review boards.
What is the purpose of subject general clinical procedures?
The purpose of subject general clinical procedures is to ensure that the clinical trial is conducted in a safe, ethical, and scientifically valid manner.
What information must be reported on subject general clinical procedures?
Subject general clinical procedures must include details on study protocols, participant recruitment criteria, informed consent procedures, adverse event reporting, and data management.
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