Compliance In Focus

No matter where you land on the clinical research spectrum, chances are you have encountered some challenges with interpreting and/or implementing Good Clinical Practice (GCP) guidelines. With so many trial designs and research settings, it can be difficult to know how to appropriately apply GCP and even more difficult at times to get answers.

To help with your search, the FDA has created a page that provides copies of e-mail messages (the original inquiry and associated reply(ies)) that have been submitted by the public to the Good Clinical Practice Program’s [email protected] e-mail account. Inquiries range from 2013 to 2018 and are categorized by the following inquiry subjects:

Clinical research professionals need to keep up to date with changes to the industry to ensure their studies remain compliant and human subjects are protected as research becomes more complex. Several important changes have taken place over recent years, including greater emphasis on risk-based and quality-focused thinking, as well as the increased use of electronic technologies to accomplish research activities.

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.

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.