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What are the minimum qualifications of an investigator?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

The regulations require sponsors to select a qualified (by training and experience) investigator who is considered an expert to investigate the drug. There are no minimum requirements or qualifications defined by the regulations. The sponsors can determine what qualifications, training, and experience will be needed in order to conduct the investigation. Familiarity with human subject protection (HSP) regulations (i.e. 21 CFR part 50 and 56) and good clinical practices (GCP) regulations (21 CFR 312) and standards (e.g. ICH E6) are among the necessary qualifications to conduct clinical studies.

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