The new FDA Guidance document, “Guidance for Industry – Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring,” has just been released. Released 8/2/2013, the 22 page document covers the development of risk-base monitoring strategies and plans for investigational studies of medical products. Some examples of that would be human drug and biological products, medical devices, and combination products.
The Risk-Based Approach to Monitoring Guidance has been released to enhance human subject protection and to improve the quality of clinical trial data by focusing on the most important aspects of study conduct and reporting. This can be done with a variety of approaches.
Users will want the Risk-Base Approach to Monitoring if they are covered by 21 CFR Part 312 or 21 CFR Part 812 (FDA Sections of the Code of Federal Regulations). And additional insight is provided for users of ISO 14155, “Clinical investigation of medical devices for human subjects – Good clinical practice.” While the guidance document does not establish a legally enforceable set of requirements, it does reflect the Agency’s current thinking on the topic.
The sections in this guidance document are:
- Introduction
- Background
- Overview of Monitoring Methods
- Risk-Based Monitoring
- Documenting Monitoring Activities
- Additional Strategies to Ensure Study Quality
- Paperwork Reduction Act of 1995
If your organization is subject to FDA oversight, you may be responsible for monitoring investigator conduct and the progress of investigational new drug (IND) or investigational device exemption (IDE) studies. The guidance reflects the growing consensus that risk-based approaches to monitoring can make such studies more effective and efficient.
To review FDA guidance documents that have been released this year, see my 2 Document Center Blogs: FDA Guidance Documents for the 1st Quarter 2013, and today’s FDA Guidance Documents for the 2nd Quarter 2013.
If you’d like to order any of these items, please use our website, www.document-center.com. You’ll be able to order paper copies or download the pdf file. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here to help you with all your compliance documentation requirements.