The FDA has announced the release of a guideline for informed consent, Guidance on Exculpatory Language in Informed Consent. The guidance is aligned with the Office for Human Research Protections’ (OHRP) recommendations. Many useful examples are included. In this web seminar, we will review examples of Informed Consent Form (ICF) language, and discuss how to apply the recommendations of the guideline to ICFs.
- Navigate the regulatory climate related to the new guideline: Why the guidance?
- Discuss the content of the guideline: What do you need to know?
- Present the implications of the guideline on current practices and policy: How does it impact how you conduct clinical trials?
- Research Site Managers
- Investigators
- Clinical Research Coordinators
- Clinical Research Associates
- Project Managers
- Clinical Research Associate Managers
- Sponsor/CRO Staff
- Clinical Quality Compliance and Quality Assurance Professionals
Sandra “SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.
Click here for complete trainer biographies
$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, 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#: 0778-0000-11-078-L01-P. Released: 9/11.
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.