Data Safety Monitoring Board (DSMB) Services

MCRA prepares for, participates in, and works with the data management team to identify events requiring adjudication for each Data Safety Monitoring Board meeting. Specifically, MCRA will provide the following DSMB services: 

DSMB Setup Activities:

  • Charter Development
  • Adjudication Form Development
  • Member Selection
  • Contract Development & Negotiation

Per Meeting Activities:

  • Clinical Document Retrieval
  • Patient Dossier Development
  • Identification of Adjudicable Events
  • Planning & Coordination of DSMB Meetings
  • Participation in DSMB Meetings
  • Post-MeetingReview & Meeting Minutes
  • Communicate DSMB Results to Sites

Clinical Events Committee (CEC) Services

MCRA prepares for, participates in, and works with the data management team to identify events requiring adjudication for each Clinical Events Committee (CEC) meeting. Specifically, MCRA will provide the following CEC services: 

CEC Setup Activities:

  • Charter Development
  • Adjudication Form Development
  • Member Selection
  • Contract Development & Negotiation

Per Meeting Activities:

  • Clinical Document Retrieval
  • Patient Dossier Development
  • Identification of Adjudicable Events
  • Planning & Coordination of CEC Meetings
  • Participation in CEC Meetings
  • Post-MeetingReview & Meeting Minutes
  • Communicate CEC Results to Sites
View Contact
Abigail Allen

Abigail Allen

Senior Director, Clinical Affairs