FDA update 30th August 2011

Draft Guidance for Industry Oversight of Clinical Investigations A Risk-Based Approach to Monitoring

The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled ``Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.''  

This Draft guidance document is being distributed for comment purposes only.

This guidance is intended

  • To assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof.
  • To enhance human subject protection and the quality of clinical trial data.
  • To make clear that sponsors can use a variety of approaches to fulfill their responsibilities related to monitoring investigator conduct and the progress of investigational new drug (IND) or investigational device exemption (IDE) studies.
  • This guidance approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively.
  • To encourage greater use of centralized monitoring methods where appropriate.
  • Sponsors of clinical investigations are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality and integrity of the clinical trial data.

The regulations require sponsors of clinical investigations involving human drugs, biological products, medical devices, and combinations thereof to monitor the conduct and progress of their clinical investigations. The regulations are not specific about how sponsors are to conduct monitoring of clinical investigations and, therefore, are compatible with a range of approaches to monitoring.

FDA conducts on-site inspections of clinical investigators, sponsors, contract research organizations (CRO), and institutional review boards (IRB) to assess the protection and safety of subjects and to validate data submitted in new drug applications (NDAs), biologics license applications (BLAs), and device premarket approval (PMA) applications. However, it is not possible for FDA to conduct on-site assessments of every clinical investigator conducting studies involving FDA-regulated products, and most inspections take place after the study is complete. Thus, effective monitoring by sponsors is critical to the protection of human subjects and the conduct of high-quality studies. FDA is considering the need for additional guidance describing overarching quality risk management approaches to clinical trial oversight. Quality is a systems property that must be built into an enterprise and cannot be achieved by oversight or monitoring alone.

PLEASE BE AWARE THAT THIS IS YOUR CHANCE TO MAKE YOUR THOUGHTS TO BE KNOWN: Written comments and suggestions may be submitted at any time for FDA consideration to the Division of Dockets Management, Food and Drug Administration, 5630  Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, refer to Docket No. FR Doc No: 2011-21972.

Or you can send your comments before November 28, 2011 at info@mdiconsultants.com and REF: A Risk-Based Approach to Monitoring.

For more information on this guidance you can go to the following link: