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.