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Can a non-licensed physician be a principal investigator for a phase 1 clinical trial (SAD/MAD)?
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- Thread starter Njdevils30
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PDF - https://www.fda.gov/media/136238/download
PDF - https://www.fda.gov/media/78830/download (see Page 5)
4. Must the investigator be a physician?
The regulations do not require that the investigator be a physician. Sponsors are required to select only investigators qualified by training and experience as appropriate experts to investigate the drug (21 CFR 312.53(a)). In the event the clinical investigator is a non-physician, a qualified physician (or dentist, when appropriate) should be listed as a subinvestigator for the trial and should be responsible for all trial-related medical (or dental) decisions. (ICH E6 section 4.3.1; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf ).
From the FDA... however, the study requires hiring a physician for the medical oversight. Because of that in practice, almost every phase 1 study I know of was led by a licensed physician.
PDF - https://www.fda.gov/media/78830/download (see Page 5)
4. Must the investigator be a physician?
The regulations do not require that the investigator be a physician. Sponsors are required to select only investigators qualified by training and experience as appropriate experts to investigate the drug (21 CFR 312.53(a)). In the event the clinical investigator is a non-physician, a qualified physician (or dentist, when appropriate) should be listed as a subinvestigator for the trial and should be responsible for all trial-related medical (or dental) decisions. (ICH E6 section 4.3.1; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf ).
From the FDA... however, the study requires hiring a physician for the medical oversight. Because of that in practice, almost every phase 1 study I know of was led by a licensed physician.
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