Informed consent is a challenging process with any clinical trial subject; ensuring understanding and agreement with a form detailing a medical study and filled with legal jargon can be time consuming and stressful. In addition, when we are faced with unusual consent situations, and the rules are not readily available, we run into questions regarding ethics and regulatory ramifications. This web seminar is designed to address some of the more unusual consent situations and address the regulations, guidances, and input from ethics committees on developing the consent document and managing the informed consent process. Considerations for use of the short form, legally authorized representatives, exceptions to the standard consent process, pediatric assent, and challenges with impaired subjects will be discussed.
- Review the informed consent process and key element requirements
- Apply informed consent principles and standards to case studies representing “unusual” circumstances
- Address processes for developing informed consent templates that meet the needs of unique study populations
- Principal Investigators
- Study Coordinators
- Clinical Research Associates
- Study Managers
- Regulatory Affairs Professionals
- Medical Writers
Nikki Christison, B.S., C.C.R.A.
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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 +1 781.972.5400 or toll-free in the U.S. 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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-14-045-L01-P. Released: 3/14.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.