Industrywide GCP Training Needed, Experts Say

An industry panel agreed Jan. 29 that industry stakeholders need to agree on a set of standards that should be part and parcel of investigators’ good clinical practice training.

FDA regulations don’t specifically address GCP training practices, and since responsibility is spread among sites, sponsors and institutional review boards, there often are multiple sets of expectations for investigators, says Bridget Foltz, a consumer safety officer in CDRH’s Division of Bioresearch Monitoring.

Compounding the problem is that principal investigators often have to complete GCP training for every trial they participate in, says Pamela Tanearts of the Clinical Trials Transformation Initiative, which is developing a set of GCP principles for use industrywide.

Tanearts, Foltz and Michael Koren, a cardiologist with the Jacksonville Center for Clinical Research, discussed GCP training during a Society for Clinical Research Sites webinar.

In general, GCP training should focus on issues that are very specific to clinical research, such as proper informed consent procedures, safety reporting or elements of compliance or noncompliance, rather than concerns of routine medical practice, Tenearts says.

Koren agrees. Investigators not only need to possess expertise in their respective therapeutic areas, they also need to have training in understanding the primary endpoint and leading staff. — Lena Freund