Thursday, March 19, 2015

GCP Investigators: Do Regulations Require a CV to be Periodically Updated?

FDA does not require updates to CVs. Initial submission of documentation of training and experience on a CV is adequate. However, a sponsor may require CV updates. USDM Life Sciences recommends you adhere to sponsor requirements that are provided during the trial.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.

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