June 2015 – by Amr Sharaf, Research Monitor
By now you’re probably already aware of what Good Clinical Practice (GCP) is; the reasons for following it; and (arguably) most importantly: what happens when you don’t. What you may not be too familiar with, however, is how to practically implement GCP in your day-to-day clinical research activities. Having documentation on GCP training is an excellent step in ensuring that you and your research team are aware of the requirements. But anyone who has ever undergone a Health Canada Inspection can tell you that the documentation itself isn’t enough – evidence that you understand and have implemented GCP into your study is what’s important. Here are a few helpful tips to make sure you’re prepared.
- Know what’s required, and what’s not: You may be surprised to learn that much of what you may be doing now is not required per GCP, but is rather a process imposed by the study Sponsor (this is more common in industry/pharmaceutical sponsored studies). Common examples of this include 100% source data verification for study monitoring, dated signatures on investigator CVs, and having fire-proof file storage rooms. None of these are required per GCP, but have become standard practice as a result of industry expectations. If you are ever informed that a certain process is required per GCP, it’s always good practice to double-check and confirm that it is in fact a requirement.
- Ensure appropriate investigator oversight: Investigator oversight refers to how engaged, involved, and knowledgeable an investigator is regarding the study at their site. This does not necessarily refer to their familiarity on the scientific merits of the study, but rather their knowledge of the day-to-day operations and overall protocol compliance. It’s critically important that investigators maintain an active role in their trials and communicate frequently with their research staff – lack of investigator/medical oversight is the #1 most common critical observation in recent Health Canada inspections.
- Optimize your protocol to achieve quality by design: Developing a scientifically sound protocol is challenging. Getting it properly funded, approved, and ultimately up and running is an even greater challenge. That’s why it’s important to ensure that your protocol has been appropriately optimized before that first patient is enrolled. Is the timing of your procedures clinically appropriate? Have you considered allowing for visit and/or study window flexibility? Are the inclusion/exclusion criteria appropriate, and not unnecessarily restrictive? Are you only collecting data that is relevant and critical to safety and efficacy endpoints? All of these questions (and more) should be answered well in advance of study start-up. A good recommendation is to have your protocol reviewed by a quality control/assurance expert (i.e. monitor, auditor, etc.) to point out potential areas of non-compliance beforehand. Being proactive can help you avoid costly protocol deviations.
While these tips can help ensure you run a GCP-compliant trial, it’s important to remember that GCP is an ongoing process that requires constant attentiveness. Ongoing training, proper documentation practices, and timely adverse event reporting are just a few other areas in which Health Canada Inspectors frequently cite observations. Ensuring you have evidence of GCP compliance is one of the most important steps in ensuring you have a robust, compliant clinical trial.