The Guidance for industry, “Guideline for the Monitoring of Clinical Investigations,” January 1988 has been withdrawn. The draft guidance, Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring” was released in August 2011. To quote from the new draft guidance, “…monitoring generally refers to the methods used by sponsors of investigational studies, or CROs delegated responsibilities for the conduct of such studies, to oversee the conduct of and reporting of data from clinical investigations, including appropriate 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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Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 0778-0000-13-020-L01-P. Released: 2/13.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.