Navigating the Complexities of Clinical Trial Success

Clinical Site Selection

Selection of an investigational site for a clinical trial is critical to success. Throughout a clinical trial, the clinicians are responsible for patients’ safety, rights, and welfare. Additionally, data integrity and regulatory compliance are necessary to secure study success. A clinical site plays a role in each of these factors. Selecting investigators qualified by training and experience is Good Clinical Practice and a requirement of US 21 CFR 312 (Investigational New Drugs) and 21 CFR 812 (Investigational Device Exemptions). Sponsors may have a list of investigators in mind while planning a trial, but CRO site databases are useful to find additional investigators. MED maintains a list of sites and investigators interested in participating in clinical studies (Site Registry).

Once potential sites and investigators have been identified, site assessment is performed. Quality procedures including standardized site assessment templates help ensure consistency and objectivity in the selection process. Evaluation criteria should be detailed and tailored to the specific trial. The following may be considered in the evaluation:

The results of the evaluation are documented in a site selection report. This report verifies investigator qualification and adequacy of the investigational site as well as provides the rationale for selection.

Overall, clinical site selection is an important process that should be executed with careful consideration to promote patient safety, data integrity, compliance, and ultimately ensuring the overall success of a clinical trial.

MED Institute offers a variety of clinical trial services including site selection and is a full-service CRO. We have over 40 years of experience designing and executing clinical trials, ranging from early feasibility studies to multinational, controlled pivotal trials to post-market registries.

Contact us today to start your project discussion.