Central Protocol and Data Monitoring Office (CPDMO)

The Central Protocol and Data Monitoring Office (CPDMO) is a Shared Resource that provides a number of centralized clinical protocol-related services. The primary objectives of the CPDMO Shared Resource are to support clinical investigators by providing assistance in developing high quality clinical protocols, by providing a centralized clinical trial registration system, by performing ongoing routine monitoring of St. Jude investigator initiated clinical trials, by participating in the design and development of case report forms and data entry screens, by providing administrative support for the Clinical Trials - Scientific Review Committee (CT-SRC) and by providing investigational pharmacy support for therapeutic standard order sets.

The primary objectives of the CPDMO Resource are to:

• Support clinical investigators by providing assistance in developing high quality clinical protocols.
• Provide a centralized clinical trial registration system to track research participant registration, accrual, and eligibility verification.
• Perform ongoing routine monitoring of St. Jude investigator initiated clinical trials at St. Jude and at collaborating institutions.
• Participate in the design and development of case report forms and data entry screens.
• Provide administrative oversight for scientific review of clinical research studies (CT-SRC).
• Ensure completion of required institutional and Federal reviews prior to accruing participants.
• Provide investigational pharmacy support, including comprehensive standard order sets (in-patient and out-patient) for therapeutic protocols.
• Serve as an on-going resource for the Principal Investigator and Study Team.

CPDMO services provided:

• Protocol development, review, and activation
• Centralized research participant enrollment
• Monitoring the conduct of research
• Investigational studies pharmacist services
• Clinical research support for regional affiliates
• Support for Collaborating Study Sites
• Clinical Research contract negotiation and disbursements
• Clinical Research Education
• Administrative support for the CT-SRC