Programme highlight
- Vendor selection, qualification, and contracting from a CDM perspective
- Vendor governance and project management in CDM
- How standards in CDM can facilitate vendor oversight
- CDM documents – reviews and approvals
- Oversight of database development
- Oversight during study conduct – data quality oversight
- TMF content from a CDM perspective
- Understanding how risk management impacts CDM oversight
Learning objectives
- Get an understanding of Data Management specifics for vendor oversight
- Be able to define which processes should be in place and which documentation should be produced in order to be able to demonstrate oversight
- Helping you to integrate CDM oversight into your vendor oversight process
Who should attend
Clinical research professionals, including Leads of a Clinical Operation Function, Clinical Project Managers, Clinical Trial Physicians, and anyone involved with setting up and management of Clinical Data Management tasks that are outsourced to a CRO or vendor.
This course is not intended for Data Management specialists.
An understanding of Data Management terminology and concepts as well as understanding Sponsor oversight requirements as defined in ICH-GCP is a prerequisite for this course.
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