Got GCP?

By Sylvia Baedorf Kassis, MPH, PRIM&R Blog Squad member

PRIM&R is pleased to bring you blog posts from the PRIM&R Blog Squad during the 2010 Advancing Ethical Research Conference. The PRIM&R Blog Squad will be blogging every day from the conference, so continue to check back for updates.
At many institutions, the only required training for anyone conducting research with human subjects is the NIH human subjects protections training. Some professionals may also be required to take an additional training on the responsible conduct of research.
When I hear this, I cringe.
Why aren’t we routinely training investigators on the proper conduct of research? It seems the assumption is that researchers learn how to conduct research in their training, but the reality of audit findings, FDA warning letters, and OHRP determination letters suggest otherwise. Being able to design a scientifically valid study is very different from overseeing the day-to-day conduct of that study. It seems obvious to me that there is not enough training on what it truly means to be a principal investigator (PI), and be responsible for the conduct and oversight of a human research study.
As part of my role as regulatory education manager in Boston University Medical Center’s Clinical Research Resources Office, I co-facilitate an optional training for PIs. This training is particularly aimed at PIs of investigator-initiated studies that do not have a sponsor providing materials and guidance to them.
Using the International Conference on Harmonization Good Clinical Practice (ICH GCP) guidance as a blueprint, we cover key topics such as documentation, informed consent, monitoring and reporting, and self-assessment. Invariably, at the end of each session, I hear from PIs who have “seen the light” and are convinced this session should be mandatory for every PI.
ICH GCP helps to ensure that its two main goals are met: to protect participants enrolled in research, and to ensure the accuracy and credibility of the data and reported results. These are of paramount importance in any clinical research study. Further, certain funders and sponsors (including some centers and institutes within the NIH) have begun emphasizing GCP and even requiring GCP-specific training for all research study staff on clinical trials.
Even if you don’t have the resources to start a formal GCP training at your institution, you can still begin the process of encouraging PIs to adopt ICH GCP. In fact, before I sign off, let me leave you with a tool that has been extremely useful in our investigator trainings.
Since the validity of research data rests in the documentation, the CRRO has developed Regulatory Binder Tabs which are an excellent starting point in facilitating adherence to GCP principles. If such materials have not been provided by the study sponsor, these tabs can be modified to enhance the organization of study documents, and can help create checks and balances to ensure the investigator and study team members are conducting the research per protocol.
For example, one tenet of the program relates to the education of staff and delegation of study-related tasks. Tools such as task delegation/signature logs allow investigators to document their oversight and ensure that that only sufficiently qualified study staff are assigned to perform certain study-related tasks. Training logs and license/certification logs, accompanied by regularly updated CVs and certifications of study personnel, can be kept as further documentation of the qualifications of study team members. Using these tools are cost-effective and important ways to improve your institution’s GCP.