The terms Essential Documents, Investigator Binder or Study Binder are sometimes used interchangeably. For all clinical research trials involving human subjects, there must be a file maintained by the Sponsor and the Investigator containing all the necessary paper work to support the clinical trial and could be called any of the above-mentioned names. During an onsite review of study records by an IMARC monitor, essential documents are reviewed to ensure that they are present, accurate, complete and current by following the ALCOA checklist and as specified in the FDA regulation 21 CFR 812.140.

Recently, we have noticed an increase in the demand for training across the clinical research landscape.  This should come as no surprise with the constant advances in technology improving the way that clinical research studies are conducted.  Those of us involved in this privilege are continually striving to keep up, and continuing education is a regular part our profession.  In addition, FDA regulations require that individuals involved in the clinical research process be qualified by training and experience.  But what constitutes “adequate” training?  This a question often asked of us by the sponsors and investigators we work with.

If you work in clinical research, chances are you are familiar with the FDA regulations (21 CFR and all of its parts). If you’re like me though, you may have a strong understanding of these regulations but still need to reference a regulatory book from time to time if you want to be sure or cite something. Well IMARC’s present to you this year is a quick reference guide for regulatory time requirements for Investigators and Sponsors of medical device research, as well as IRBs. For space sake, we are paraphrasing. Please don’t feel obligated to get us any gifts in return. You can give the gift of human subject protection to every research subject involved simply by striving to meet these requirements.

Medical device sponsors, according to 21 CFR 812.40 and 812.46, are responsible for monitoring clinical trials.  The regulations require that sponsors monitor a trial at a site by ensuring that an investigator is compliant with the federal regulations, agreements with the sponsor, the investigational plan, and the requirements set forth in the approval of the study by the IRB.  It is also the responsibility of the sponsor, according to 21 CFR 812.43(d) to select monitors qualified by training and experience to monitor a study in accordance with 812 and other applicable FDA regulations. Sponsors may also appoint other individuals and groups to ensure compliance and proper clinical trial monitoring as well as evaluate the accumulating outcome data. The FDA guidance, The Establishment and Operation of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors, defines a Data Monitoring Committee (DMC), also known as Data Safety Monitoring Boards (DSMBs) or Data and Safety Monitoring Committees (DSMCs), as a group of individuals with pertinent expertise that reviews, on a regular basis, data from one or more ongoing clinical trials. Additionally, DMCs:

FDA regulations can seem all encompassing at times, especially when trying to run a clinical trial in compliance with the various rules and standards. While many in clinical research would not argue that there are not enough regulations governing clinical research practices, the question remains: Are there too many gray areas?