Good Clinical Practice (GCP) Practice Exam

Non-compliance with Good Clinical Practice (GCP) can lead to potential legal liabilities and sanctions, which is a significant consequence. GCP guidelines are established to ensure that clinical trials are conducted ethically, and that the data generated is credible and reliable. If researchers fail to adhere to these guidelines, they may face penalties from regulatory bodies, including fines, suspension or termination of trials, and even criminal charges in severe cases.

Moreover, non-compliance can negatively impact the integrity of the trial data, potentially misleading stakeholders, including healthcare professionals and patients. It can also result in the loss of the ability to publish results and gain approval for new drugs or treatments from regulatory agencies. These ramifications underscore the importance of compliance in safeguarding the rights and welfare of research participants and maintaining public trust in clinical research.