FDA Issues Final Guidance for Oversight of Clinical Investigations - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Issues Final Guidance for Oversight of Clinical Investigations
The guidance describes a risk-based approach to monitoring of clinical trials.


FDA has issued final guidance, Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring 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. The overarching goal of the guidance is to enhance human subject protection and the quality of clinical-trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting.

The guidance specifies that sponsors can use a variety of approaches to fulfill their responsibilities for monitoring clinical-investigator conduct and performance in investigational new drug studies conducted under 21 CFR part 312 or investigational device exemption studies conducted under 21 CFR part 812. The guidance describes strategies for monitoring activities that reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively. For example, the guidance specifically encourages greater use of centralized monitoring methods where appropriate.

The guidance focuses principally on monitoring, which is one aspect of the processes and procedures needed to ensure clinical-trial quality and subject safety. Monitoring is a quality-control tool for determining whether study activities are being carried out as planned, so that deficiencies can be identified and corrected. The guidance specifies that monitoring, or oversight, alone cannot ensure quality and that quality is an overarching objective that must be built into the clinical-trial enterprise. FDA recommends a quality risk-management approach to clinical trials and is considering the need for additional guidance describing this approach.

The guidance was prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research (CDER) in cooperation with CDER’s Office of Scientific Investigations in the Office of Compliance, the Center for Biologics Evaluation and Research (CBER)’s Office of Compliance and Biologics Quality, the Center for Devices and Radiological Health’s Office of Compliance, the Office of the Commissioner’s Office of Good Clinical Practice, and the Office of Regulatory Affairs.

Source
FDA, Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring (Rockville, MD, August 2013).

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

Click here