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; 8:30 - 10:30 p.m. Eastern
August 26 2010
$695
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, 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#: 778-000-09-063-L04-P. Released: 2/10.
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For more information, contact Naila Ganatra at (215) 413-2471.