Study monitoring is an important component of study conduct that is designed to ensure compliance with the protocol, Good Clinical Practice, Federal and local regulations, and institutional policies. Where the investigator is serving as the sponsor, study monitoring also offers protection to the investigator and the institution. In many cases, a developed Study Monitoring Plan is a required element of NIH grant applications involving proposed clinical research studies.
The Clinical Research Center (CRC) at Boston Children’s Hospital now offers monitoring services for investigators in need of independent monitoring at an economical price. CRC monitors are experienced clinical research professionals that have completed competency-based monitoring education. Priority for monitoring is given to faculty acting as the regulatory sponsor of an IND or IDE clinical trial to aid those investigators with fulfilling federal regulatory requirements to perform safety monitoring.
To further discuss study monitoring for your protocol, please contact Cindy Williams: Lucinda.firstname.lastname@example.org.