Compliance In Focus

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

How is auditing different than monitoring?  Why do we need to audit?  Since these questions are so often asked, we decided to create a graphic that will help you understand when to consider an audit. In short, auditing brings an independent, quality assurance perspective to the clinical research landscape Investigational sites, sponsors, and vendors benefit from high-level process assessments and improvements. Experienced auditors leverage extensive training to help ensure subject safety, data integrity, and protocol and regulatory compliance.

Whether on the site or sponsor level, in clinical research we are asked to use  Good Documentation Practices (GDP) during the conduct of a clinical trial.  One might assume that a quick visit to the FDA website would produce the list of practices.  However, there is no Code of Federal Regulations for GDP.

The informed consent process is arguably one of the most important parts of a clinical research study. From the Principles of ICH GCP: the rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. Proper informed consent ensures that the patient is aware of the risks and requirements of being in a research study and has voluntarily agreed to participate in research.  The regulations, CFR part 50 also cover the importance, rules and process of informed consent.