As commonly defined, Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design
and conduct of clinical trials involving humans. The primary objectives of GCP are to protect the safety, rights, and welfare
of subjects, and to ensure the credibility of trial data and resulting reports. The need for ethical standards in clinical
practice came about in response to instances of data fraud and other scientific misconduct, and as a result of numerous examples
of violations of human rights in research such as those committed in the Tuskegee syphilis study where subjects were never
told they had syphilis and were never treated for it.
The Food and Drug Administration has had GCP regulations in place since the 1970s and these were expanded in 1997 with the
addition of E6 GCP to the Federal Register. E6 GCP states that individuals performing clinical research must be qualified
by training and experience (21 CFR 312.53: Selecting Investigators and Monitors; ICH E6 5.18.2: Monitoring; ICH E6 5.5.1:
Trial Management Data Handling, Record Keeping), although specific standards of GCP training are not referenced.
Pharmaceutical companies initially responded to E6 GCP by placing more emphasis on implementing GCP training for investigator
sites. Basic training was (and is) offered at investigator meetings, but it often includes nothing more than a high-level
overview and, because it is often time constrained, it may not include all of the critical elements. There is typically no
knowledge check or completion documentation at the end of these sessions, so it may not qualify as GCP certification.
As the need for improved GCP training was recognized, many pharmaceutical companies developed intensive, instructor-led, in-house
courses for their clinical operations staff. Although many of these courses included practical application exercises, there
was often no knowledge check, so the value was greatly diminished. This is also a costly method of instruction for companies
if decentralized staff members are expected to attend in person. For this reason, many companies progressed to web-based programs
or other methods of training for both investigational and operational staff. In addition to in-house or web-based instruction,
sponsor companies and CROs may use an independent GCP training consultant to implement company-specific GCP training or may
send staff to a clinical research, professional society, or commercial training course. Some companies offer only a slide
review followed by a knowledge check to document their training.
Current GCP expectations are that principals investigators and sub-investigators are trained in GCP and that this training
is documented and tracked. It is expected that sponsors' clinical operations staff members are also trained in GCP, but there
are varying requirements for refresher courses, documentation, and tracking. Regulatory agencies may have a reasonable expectation
that clinical staff members are GCP-qualified, but currently there is no guidance that specifically defines what topics GCP
training should include.