How GCP Guidelines During COVID-19 Impact Your TMF

By Karen Roy

On April 16, 2020, the US Food & Drug Administration (US FDA) released an update¹ to its March 2020 guidance on the conduct of clinical trials during the current COVID-19 health crisis. Our TMF and regulatory experts have analyzed the updated guidance to develop the following summary and recommendations pertaining to TMF and document management during this period.

Note: This blog post is intended to be a brief summary of the updated guidance and is not exhaustive. We encourage you to read the guidance, and to contact us with any questions you may have. Our TMF and compliance experts are on call to help you throughout this period and beyond.

It should not come as a surprise that the FDA is putting patient safety first and foremost in its guidance. As noted in the introduction on page four, the FDA “is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 public health emergency.” (emphasis mine)