Managing clinical investigator compliance to ensure Food and Drug Administration (FDA) inspection readiness

I conducted my clinical research and management internship at the Dallas headquarters of MedTrials, a full-service contract research organization (CRO). As a full-service CRO, MedTrials offers professional services including clinical trial management, monitoring, auditing, training, data management, statistical analysis and reporting in all phases and types of clinical trials. MedTrials is dedicated to provide high quality customized solutions to clients throughout the pharmaceutical, medical device and biologics industries.;For my practicum report, I focused on 'Managing Clinical Investigator Compliance to Ensure Food and Drug Administration (FDA) Inspection Readiness'. Compliance in clinical trials is adherence to the federal and other applicable regulations. In the U.S. The FDA is responsible for protecting the subject safety in clinical trials involving drugs, biologics, devices, veterinary products and food products. The FDA conducts inspections of the sites conducting clinical trials to check for the site compliance. These inspections are conducted by a program called Bioresearch Monitoring (BIMO). BIMO is responsible for on-site inspections and data audits. The goal of the BIMO program is assuring quality and integrity of FDA regulated research data submitted to the agency in support of new products approval applications and also to ensure protection of rights and welfare of thousands of human subjects participating in clinical trials under the applicable regulations.;Knowledge of common causes leading to non-compliance findings during inspections by the FDA is useful in preventing future non-compliance issues at the sites and thereby, official actions by FDA. Specific aims of this internship project were designed for obtaining knowledge on the compliance issues focused by the BIMO inspectors. Specific aim 1 focused on statistical data of BIMO inspections on clinical investigators and sponsors/monitors. For this the BIMO accomplishments updates published on the FDA website were reviewed. The second specific aim was designed to obtain three most common non-compliance issues at the clinical sites. For discovering the common non-compliance issues, FDA warning letters were reviewed and an electronic survey was conducted. The results indicated the most common non-compliance issues focused by the BIMO inspectors and monitors responsible for checking the compliance differ from each other. The third specific aim was intended to develop a tool that can be used by sponsors/CRO for assessing site compliance during the study and to prepare recommendations for preventing the common compliance issues at the sites. For developing the tool for assessing site compliance, FDA warning letters were reviewed and compliance areas focused in them were noted and a checklist was prepared. This checklist could be used by monitors during their site monitoring visits. The recommendations could help the sponsor in preventing common non-compliance issues at their sites thus pro-actively preventing official actions by FDA inspectors.;Along with working on my practicum report, I assisted both the clinical and quality assurance departments of MedTrials. I worked in the role of compliance specialist and assisted both the departments in ensuring internal and site compliance of various studies.