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# FDA Modernizing GCP Guidelines: Attorneys
- URL: https://www.fdaweb.com/fda-modernizing-gcp-guidelines-attorneys/
- Published: 2023-08-08T12:00:00.000Z
- Updated: 2026-09-14T18:49:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155051

Three Morgan Lewis attorneys say an updated FDA draft [guidance](fda.gov/media/169090/download) to implement the International Council for Harmonizations good clinical practice (GCP) guidelines is part of a series of agency documents demonstrating its interest in modernizing the guidelines to account for emerging technologies. An online [post](https://www.jdsupra.com/legalnews/high-tech-revamp-fda-announces-new-3516353/?ref=fdaweb.com) says FDA’s receptivity to new technologies, acknowledgment of decentralized clinical trial sites, and the outsourcing of clinical trial functions “does not indicate that FDA will reduce the need for control over these innovations. Sponsors will have to be equally innovative in developing control mechanisms to ensure continued protection of human subjects and data integrity.”

The attorneys write that the agency’s focus on digital health technologies and on processes and procedures for promoting data integrity “should be considered in light of the agency’s determination to place compliance obligations on a wider range of parties involved in clinical research throughout the trial process, including contractors that provide biostatistical support, data scientists, and data managers. Sponsors, contract research organizations, and third parties will also have to ensure ongoing compliance with FDA’s GCP expectations.”

Comments on the draft guidance will be received until 9/5.