What are the minimum qualifications of an investigator?

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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.

About the Author
Proxima CRO Team
Aryan Abedi
Quality Assurance Intern

Aryan received his B.S. in Biomedical Engineering from Texas A&M University. He has experience in Design and Development, Quality Control, and Quality Assurance and is particularly interested in the use of biomaterials and production of cost-effective medical devices to improve quality of life for patients from various socioeconomics background.  

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