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Archive: Electronic Informed Consent Guidance: Regulatory Updates

Course #: BI14780
December 15, 2021
WebSeminarArchive

Course Description

Conducting the informed consent process is one of the most critical tasks to be completed by a research site. It’s essential that a subject clearly understands the information and language in the consent form and that their rights, safety, and welfare are not jeopardized. This web seminar will review the essential language in the informed consent document through review of the FDA regulations and guidance documents, including the December 2016 final guidance, “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” Additionally, there will be discussion of some of the challenges faced in consenting pediatric subjects in trials of greater than minimal risk, the use of translators, and review of the use of electronic informed consent and electronic signatures.

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Learning Objectives

  • Explain the content of the recent guidances related to informed consent
  • Discuss the implications of the guidances on current practices and policy
  • Analyze the use of electronic media and processes to obtain electronic informed consent (eIC)
  • Discuss implications and best practices of electronic signatures on consent documents

Who Should Attend

  • Research Site Managers
  • Investigators
  • Clinical Research Coordinators
  • Clinical Research Associates
  • Clinical Research Associate Managers
  • Project Managers
  • Sponsor/CRO Staff
  • Clinical Quality Compliance and Quality Assurance Professionals

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.