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Feasibility Discussion Date:Cancer Center Office of Clinical Research: Protocol Submission Form Trial Information Protocol Title & Study Number/Short name:Sponsor Name:PI & Title:Subinvestigators
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Read the ICH GCP E6 section carefully to understand the requirements.
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Provide all necessary information as requested, including study details, sponsor information, and investigator details.
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ICH GCP E6 section refers to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice section 6.
All parties involved in the conduct of clinical trials are required to file ICH GCP E6 Section, including sponsors, investigators, and ethics committees.
ICH GCP E6 Section should be completed according to the guidelines provided by the International Council for Harmonisation.
The purpose of ICH GCP E6 Section is to ensure the proper conduct of clinical trials and the protection of human subjects involved in research.
ICH GCP E6 Section must include information on the study protocol, informed consent process, monitoring procedures, and adverse event reporting.
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