Good Clinical Practice: What It Is, Why It’s Important and How to Achieve It
Summary
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. 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. GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies. 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 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.
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