The final guidance, “Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring” was released in August 2013. To quote from the new guidance, “…monitoring refers to the methods used by sponsors of investigational studies, or CROs delegated responsibilities for the conduct of IND studies, to oversee the conduct of and reporting of data from clinical investigations, including appropriate Clinical Investigator supervision of study site staff and third party contractors.”
We will examine the expectations for the clinical data management (CDM) contributions to assist in this initiative, and the role that CDM can play in ensuring that risk is minimized when it applies to data quality.
- Recognize the rationale regarding risk-based monitoring
- Illustrate the active role that CDM is expected to exhibit in this approach
- List the potential CDM reports to assist in identification of data aberrations
- Interpret the way forward for future CDM activities
- Clinical Data Managers
- Clinical Research Associates
- Clinical Trial Managers
- Project Managers
- Quality Assurance Personnel
Denise G. Redkar-Brown, MT
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.