QRTI Newsline --- Wednesday September 8, 2010

How Do You Assure Adequate GCP Training of Investigational Study Staff?

By Phyllis B. Kent

What is the most effective way to assure GCP training of clinical sites? Sponsors rely on the site staff to conduct their studies in compliance with GCP requirements. Which of these typical methods do you use to assess the GCP competency of your sites?

• PI assures that staff know GCPs
• Staff members are verbally quizzed to assess GCP knowledge
• Obtain copies of GCP Training Certificates
• Require documented GCP training
• Site staff are given a written GCP quiz
• Rely on previous study experience
• Require attendance at sponsor provided GCP training

Sponsors need to assess the GCP knowledge of site staff before placing a study to assure that they are qualified to conduct GCP compliant research. Most sponsors require that CVs are collected for all individuals at the site who will be involved in the study. While the staff CVs detail degrees, licenses and experience, documentation of GCP training is usually absent. Occasionally, a staff member will have a GCP training certificate; however, most clinical site staff does not attend independent GCP training courses due to the cost and time away from work.

Monitors conducting the Pre-study visit usually have to assess the site staff's GCP knowledge without documentation of GCP training. Furthermore, monitoring SOPs rarely provide tools for the measurement of GCP competency of the investigator or the study staff, and standard GCP tests are not available. This often results in monitors that do not know how to determine the GCP qualifications of their prospective sites.

To compensate for the lack of assessment by the monitors, many Sponsors provide training to clinical sites to assure that all of the staff are familiar with GCPs. In order to enable exposure to all aspects of GCP regulations, training courses should be at least 4-8 hours in length. Some Sponsors add GCP training to their Investigator Meetings. However, due to the amount of study information to be communicated, GCPs are frequently omitted in order to keep the meeting timeframe to a single day. In some cases, the Sponsors have the training department visit each site to conduct the training program. This approach requires a significant commitment of travel time and expenses for the training department and utilizes trainers without the field experience to provide solutions to site questions.

Another solution is to provide "on demand" web-based training to be completed by the staff when their schedule permits. Some sponsors offer GCP training CDs. These options do not allow the opportunity for the site staff to ask questions. Assessment of GCP competency gained from these programs has limitations.

The best solution is a formal GCP Site Instruction Program to train monitors to teach GCPs and which provides the assessment tools to evaluate site staff's GCP knowledge. Enabling the monitor to provide staff instruction ensures GCP awareness. The study team receives the training before or at the trial initiation following a program that the sponsor has assured contains the essential GCP requirements.

• On-site training to the entire staff is cost efficient since the monitor will already be making pre-study visits to the site. Site Staff time away from the office is minimized.
• Assessments are built into the program to provide assurance of understanding by the staff.
• The monitor is available to the site for follow-up questions
• The monitor can instruct newly joining staff

The challenge for the sponsor is to assure that the monitors are well prepared to provide GCP training. This requires sponsors to provide a "Train-the-Trainer" GCP program for all monitors responsible for site training. Sponsor training departments need to develop the course materials, resources, handouts and assessment tools. Sponsors who cannot provide the monitors with this type of a program due to a lack of resources, may have to seek outside GCP training providers to prepare the monitors for their instructor role.

The investment in a thorough GCP Site Instruction Program will pay off long term with more compliant sites and less rework for both the site and the monitor.

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