TransCelerate - Data Monitoring Committee

Data Monitoring Committee

The Data Monitoring Committee Initiative aims to facilitate the development of a means of expanding clinical trial sponsors’ access to a broader pool of candidates when convening DMCs, and to provide an approach for newly identified individuals to gain experience through mentoring relationships. As of November 2021, the Data Monitoring Committee Initiative is complete. There are no new deliverables or updates planned.

Rationale

The Data Monitoring Committee (DMC) Initiative addresses the challenge of a limited and diminishing number of experienced candidates available for service on DMCs, in the face of increasing clinical trial monitoring needs. This initiative aims to identify a means of expanding clinical trial sponsors’ access to a broader pool of sufficiently skilled candidates when convening DMCs. As of November 2021, the Data Monitoring Committee Initiative is complete. There are no new deliverables or updates planned. The Society of Clinical Trials has implemented TransCelerate’s guidelines into a Data Monitoring Committee Registry and DMC Training Resource Library.

Benefits

Enhance skills and number of candidates capable of serving on DMCs, benefiting both individuals desiring to serve on DMCs and sponsors searching for competent DMC members
More options for sponsors in selecting DMC members
Increase DMC candidate visibility to clinical trial sponsors (thus increasing opportunities to impact cutting-edge research)

Related Initiatives

Protocol Deviations

The Protocol Deviations Initiative has developed a toolkit to support clarity in definition and a holistic approach to the management of protocol deviations. Click before to access these materials.

Risk Based Monitoring

The Risk Based Monitoring Initiative was established in 2012 as one of the five initial goals created by TransCelerate to drive efficient and effective solutions into the R&D industry. Clinical trial sites have varying levels of experience and quality, but monitoring approaches are not designed to manage potential differences.

Quality Management System

Through partnerships with Health Authorities and other industry stakeholders, the Quality Management System (QMS) Initiative aims to explore ways to improve quality across the industry.