The FDA has recently released a new guidance regarding how Sponsor/ Sponsor side CROs should be monitoring their clinical trial sites. The guidance primarily notes that the main focus for Sponsors and Sponsor side CROs should be on taking measures which protect human subjects, while maintaining data integrity and compliance with regulations.
Many Sponsors are currently under the belief that frequent on-site monitoring visits in order to verify all data is the method most preferred by the FDA. In fact, the agency states in the recent guidance that centralized monitoring can, and should be considered. The reasoning behind their position is that typical problems with data, such as fraud, can be more easily and consistently detected by centralized monitoring techniques.
The FDA does not however, believe that Sponsors and CROs should completely abandon the on-site monitoring visit. In fact, the agency urges them to conduct at least one on-site visit, preferably in the early stages of the study, in order to evaluate the sites processes and controls for handling source documents. Additionally, the agency recommends more on-site visits in cases where the PI lacks significant experience or when there are significant safety concerns due to a product for which there is no prior experience in human clinical trials.
The aforementioned aspects of the FDA’s recent guidance can all be addressed through CTMG processes, which provide the type of constant oversight and centralized monitoring which the agency heavily favors in comparison to intermittent on-site monitoring. In addition to daily review of subject pre-screening, patient visit scheduling and study enrollment - with the application of corrective and/or preventative actions as indicated – internal source document quality assessment and correction are all managed for the investigator by CTMG personnel as part of the study. This constant vigilance provided by CTMG clinical coordinators, regulatory personnel, QA personnel, as well as executive management, creates the type of centralized monitoring infrastructure requested by the FDA in their recent guidance.
For additional information on CTMG services and processes, please visit http://www.ctmginc.com. For Business Development inquires, please contact David Holland, Business Development Manager, at dholland@ctmginc.com.
CTMG is the world’s first Site Specific CRO (SS-CRO) with, to the best of our knowledge, the highest clinical study enrollment and retention metrics in the world. Our trial management service utilizes our experienced personnel to implement design-reviewed cGMP-like processes, under proprietary layered Quality Systems, at our Business Associate Physician Investigator sites.
