Observational studies in the biopharmaceutical and medical device industries encompass various designs and purposes, including post-approval safety studies, product or disease registries, pregnancy registries, medical chart reviews, and cohort studies. This web seminar offers practical approaches to the management of observational studies, focusing on issues and aspects that occur commonly, differ from clinical trial management, and are key to program success. Topics to be addressed include project oversight, ethics/Institutional Review Board (IRB) approvals, data quality management, site and subject recruitment and retention, and protocol adherence.
- Employ techniques for managing observational studies differently than clinical trials
- Explain common pitfalls with observational studies
- Utilize proactive strategies to improve observational study conduct
- Staff from biopharmaceutical, medical device, or contract research companies who are or who will be involved in observational studies
- Project Managers and Team Leaders
- Clinical Research Professionals
- Clinical Safety/Pharmacovigilance Professionals
David Stier, M.D.
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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 1.5 hours (0.15 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#: 0778-0000-12-065-L01-P. Released: 8/12.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.