Investigator non-compliance to the Statement of Investigator commitments has increased in many areas. One of the identified causes has been monitoring. Investigator compliance issues are great risks to product development success, but an even greater risk to sponsors is the lack of formal systems to manage compliance at research sites. With the promise of more sponsor inspections, the sponsor management of investigators’ non-compliance is an obligation that requires comprehensive management approaches that lead to control of investigational product, data integrity, and adequate documentation for regulatory inspection of sponsors monitoring programs and/or investigative sites. Seven steps in compliance management of research sites will be presented for the participants to assess their current practices for gaps and risks for preparing for potential regulatory inspection evaluating compliance management of research sites.
- Categorize investigator non-compliance
- Define adequate escalation of non-compliance
- Summarize proactive investigator training related to sponsor’s response to non-compliance
- Employ seven comprehensive steps in compliance management
- Detect trending to better anticipate compliance issues
- Project Managers
- CRA Managers
- QA/Compliance
- CRAs
Sandra SAM Sather, MS, BSN, CCRA, CCRC
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2 hours; 12:30 - 2:30 p.m. Eastern
April 15, 2010
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For more information, contact Naila Ganatra at (215) 413-2471