fda guidance

FDA Issues Guidance for Clinical Research Investigators

Posted by Christine Pierre on Tue, Oct 27, 2009

Protecting the rights, safety and welfare of study subjects is the number one priority when conducting clinical research.

The FDA recently released (in October 2009) a "Guidance for Industry" paper which provides Clinical Research Investigators guidance on their responsibilities in protecting the rights, safety and welfare of study subjects. This guidance paper contains numerous expectations and clarity of how Investigators should be managing and conducting their clinical research.

While there are many outstanding directions for Investigators to follow, one thing that jumps out from my perspective is the need for Investigators to demonstrate "adequate supervision of the conduct of an ongoing clinical trial (#3 in paper)." The guidance paper states there should be "a plan for the supervision and oversight of the clinical trial at the site..." and then goes on to discuss methods that could accomplish this expectation. It is clear that sites could easily demonstrate compliance with this expectation by documenting every regular research meeting held between the Investigator and the research team. An example of a type of form that would capture this documentation can be found on our RxTrials Institute page.

Are you ready to demonstrate investigative control of your research? Does your site have the proper documentation lined up? I encourage all of you to share ways to improve upon this and share other ideas about ways to meet the expectations outlined in this document.

Dialogue among all in our industry about how to implement these newly clarified expectations will only benefit the entire clinical research enterprise and as the title of this guidance paper states - it will ‘protect the rights, safety and welfare of our study subjects.'

Looking forward to your comments so we can share with one another and learn.

- Christine Pierre, RxTrials

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