KEYS TO EFFECTIVE CLINICAL TRIAL SITE MANAGEMENT

May 14 2015 Kara Grew

Proper site management by the Sponsor and/or CRO is an essential element of clinical trial execution and in ensuring trial success. An appropriate level of site management and oversight empowers sites to effectively recruit, treat, and retain subjects while ensuring regulatory compliance, protocol adherence, the protection of subjects’ rights, subject safety, and overall management of screened and enrolled subjects.

Site management goes beyond simply monitoring a site, and, rather, focuses on regular, consistent communication with sites during study start-up, maintenance, and closeout. Is it essential that sites have a reliable, primary point-of-contact during the course of a trial and that sites understand the importance of maintaining regular communication with the Sponsor and/or CRO. In most cases, the primary point-of-contact is the CRA; however, in some cases it may be an alternative contact such as a Project Manager or Site Manager dedicated to site communications. Sites should have a solid understanding of whom to contact with questions, issues, and concerns that may arise at any point during the trial. An open pathway of communication must be maintained. Presenting a clear understanding of the communication flow will often reduce protocol violations and deviations, and address data issues and questions, thereby increasing the quality and integrity of clinical trial data.

In most cases, it is most efficient that the site’s CRA also serve as the Site Manager so the site has one primary point-of-contact for the duration of the trial. All communications should be properly documented and filed in the Trial Master File and the site’s Investigator Site File (regulatory binder).

Proper site management during pre-study activities includes proper management of site feasibility review, investigator selection, and site qualifications. During site initiation, the CRA and/or Site Manager will oversee start-up and training and will set recruitment expectations for the site. During the enrollment period, site management involves facilitation and review of enrollment, ensuring regulatory compliance and adherence to the protocol, management of adverse event reporting, CRF/eCRF review and query resolution, remote and on-site monitoring, data collection, and ensuring proper investigator oversight at each clinical research site. Finally, during the study closeout period, the CRA/Site Manager would support the site in addressing data queries for database lock, completing final source data verification of CRFs/eCRFs, ensuring protocol adherence, and managing the collection of final safety data. Lastly, site management involves final review and accountability of all study drug, and final review and collection of all relevant regulatory documents, ensuring the site is “audit-ready” and understands record retention requirements.

It is essential that the CRA and any additional Site Manager(s) continue to be a resource for each site throughout the duration of a trial. If a new CRA or Site Manager is assigned to a site mid-trial, all relevant site information, including comprehensive monitoring reports, should be provided to the new CRA/Site Manager to ensure proper follow-up on outstanding issues and continued, consistent communication with site personnel.

The key to developing a solid working relationship with a site, and in collaborating with sites, is ensuring proper site management during all phases of a trial. This collaboration leads to increased efficiency and productivity, proper review of subject safety, consistent communication, adherence to regulations, and increased data quality, and promotes an adequate level of oversight during the course of a trial.

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