“But, Officer…”

Featured Blog by Denni O. Day

The FDA’s Code of Federal Regulations (21 CFR 312.53 and 812.43) requires that anyone involved in clinical research be properly trained to perform their research activities. For clinical field trials, this requirement would apply to sponsor project leaders, study investigators, site coordinators, field monitors, and others directly involved in the conduct of the study. Training certainly would include a detailed review of the protocol and related case report forms, discussion of the inclusion/exclusion criteria and required laboratory tests, development of subject enrollment strategies, and agreement on deliverables and study timelines. Another key component of any study training should be a thorough review of VICH GL9 (Good Clinical Practice) guidelines or, as they are more commonly called, GCPs.

Some people think that GCP training is a once-in-a-lifetime exercise because, like riding a bicycle, you never really forget what to do. Others disagree and suggest that GCP training should be repeated with some regularity to keep its tenets in sharp focus. This disparity of opinion prompted me to contact a selection of industry colleagues to pose the question: “When, and how often, should GCP training be conducted?” It was most gratifying to receive responses from 41 of the 48 colleagues I contacted (30 from pharmaceutical/nutraceutical companies, 7 from CROs, and 4 industry consultants).

Nearly everyone said that their organization conducted GCP training of some sort either immediately prior to the start of each new study or as part of the study’s investigator training meeting. Some colleagues suggested that, since few veterinarians employ GCP principles every day, a thorough review of the guidelines during study training would improve their performance as investigators once the study got underway. Others noted that each study’s unique design might heighten the importance of certain aspects of GCPs, which could warrant special consideration during training. A few respondents cited investigators who can recite verbatim specific GCP sections, and one of these respondents also suggested that it might be instructive to explore why these investigators are so familiar with those GCP sections and then use the causal events as training examples for other investigators. One respondent questioned whether GCP training might better be scheduled in response to actual need to be most effective. However, all respondents seemed to feel that everyone could benefit from a GCP refresher course from time to time.

This is especially true today, as technology continues to play an ever larger role in our industry. For example, the growing use of electronic data capture (EDC) presents special challenges. Since the computer assumes “responsibility” for contemporaneous data entry and form field legibility, could some investigators become less vigilant in other areas of GCP compliance? If that’s true for studies employing EDC, it may be necessary to remind all such study participants of what EDC can and cannot do, and what remains the responsibility of each study team member.

So, if one training is not enough, how often should we refresh our knowledge of GCPs? Several respondents felt that GCP training should be conducted annually for all study monitors, regardless of whether they currently were involved in a study. This certainly would sharpen their understanding of the guidelines and help them prepare other study team members to better fulfill their duties in future studies. For those who monitor studies on a full-time basis, annual training makes a lot of sense. Most respondents felt that part-time monitors should receive GCP training prior to the initiation of each study and refresher training as their performance may dictate. Almost everyone agreed that, for long field trials (those lasting a year or longer), remedial or refresher GCP training should be conducted at some interim point(s) to bolster investigator compliance, prevent protocol deviations, and heighten data quality. One person suggested that GCP training should be structured around actual investigator errors because real-world examples might be more effective teaching tools.

The common thread in all of the responses I received is that GCPs are very important “rules of the road” that must be followed if we are to be successful in our research endeavors. And, like the actual rules of the road that we travel in our cars, a refresher course in GCPs now and then will reduce the likelihood of having an “accident” or getting a “ticket.”

I am grateful to the 41 colleagues who were most generous with their insights and comments. I would have liked to credit each of them by name here, but almost all requested anonymity for personal and/or business reasons