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Electronic Informed Consent Guidance: Regulatory Updates

June 6, 2022 @ 12:00 pm - 1:30 pm

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.

Participation in these training courses are offered on a first-come-first-serve basis. Depending on the level of responses, there may be limited availability.

Want to attend this training session in real time? REGISTER HERE to attend the live session. Deadline for live course registration is June 3rd, 2022.

Not able to make this date? CLICK HERE to register to view a recorded session.

 

Details

Date:
June 6, 2022
Time:
12:00 pm - 1:30 pm
Event Category:

Organizers

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Department of Health and Human Services