When conducting clinical research, the ultimate goal of a Principal Investigator (PI) and their staff is to determine whether the studied intervention can progress to the next stage of testing or approval. One of the biggest challenges, however, is to do so while keeping their participants’ safety in the forefront of their mind. Developed by the International Conference on Harmonisation (ICH), Good Clinical Practice (GCP) is put in place for FDA-regulated studies, ensuring the participant’s wellbeing throughout the trial.
What is GCP?
GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies. There are 13 core principles set in place to ensure safe and ethical research. These principles, while self-explanatory, remind clinical research staff that the welfare of the trial participants should be of the utmost importance when conducting clinical research.
The GCP standards set in place are simply guidelines for conducting clinical research and are only applicable to FDA-regulated research. Research is regulated through the FDA if the trial contains a test article, human subjects and does not include non-clinical laboratory studies. Non-FDA research projects are not obligated to follow GCP, however, following GCP even when it’s not required typically follows best practices of a study.
Why is GCP important?
As previously stated, the main goal of GCP is to ensure quality data, but also to ensure subject rights and safety. GCP also holds everyone involved in the clinical trial accountable for what is going on – including PI, sponsors and the Institutional Review Board (IRB). When conducting a study, everyone involved should be confident that the benefits of conducting clinical research outweigh the risks involved.
As the protocol moves through its phases, consistency must be maintained. When the intervention moves along an application towards approval, the relevant data is maintained in a Trial Master File (TMF). In the TMF, GCP plays an important role in ensuring the completeness of the data.
How to achieve GCP
While there isn’t a formal list to check off in order to achieve GCP, the good news is it can be easy to accomplish.
The four different parts in a clinical protocol work to help build GCP: glossary, principles, responsibilities and documentation. When done completely and accurately, these parts cumulatively define common terms and acronyms, hold research staff accountable and help with development and conduct of a clinical trial. Each part helps convey that the study is designed to ensure ethical research, as well as the safety of the participants.
Additionally, there are different online trainings available so research staff can grasp what it means to obtain GCP. Trainings are held in the form of courses, classes, academic training programs or certifications. It’s important to keep up-to-date on GCP trainings as you move through your research process, as it helps ensure your trials are staying up to standard. Knowing how important it is, your institution might offer courses for you to take. If not, there are plenty of resources online to help you gain a better understanding of GCP.
These are just a few pieces of information to keep in mind as you move your study through the trial process. Taking these tips into consideration not only ensures a smoother trial, but also keeps everyone accountable to protect an important part of the trial as they move through the trial themselves: the patients.