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FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016

Re-Posted from eCF LinkedIn Group

  • 16 December 2016
  • Author: REG Team
  • Number of views: 13798
  • 0 Comments
FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016

The Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) published final guidance aimed at providing answers to commonly asked questions about using electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. This guidance finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” issued in March 2015. The final guidance was developed in collaboration with FDA and OHRP and is issued as a joint final guidance.

Final Guidance for Industry: “Use of Electronic Informed Consent--Questions and Answers.”
Federal Register Notice:
https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/pdf/2016-30146.pdf
https://www.gpo.gov/fdsys/pkg/FR-2016-12-15/html/2016-30146.htm

Informed consent is the process of providing a subject with adequate information to allow for an informed decision about his or her voluntary participation in the clinical investigation. FDA believes that informed consent should include a process that facilitates the subject’s comprehension of the information and allows adequate opportunity to ask questions and consider whether or not to participate. Furthermore, this process often continues beyond obtaining the subject’s initial consent at the time of enrollment. It may involve providing information as the clinical investigation progresses or as the subject or situation requires.

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Birds-of-a-Feather Round Table Discussion: U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials

Presenter/Facilitator:  Ken Light, Clinscape

In 1996, HIPAA legislation called for the development of a national patient identifier system that would give each person in the United States a permanently assigned, unique number to be used across the entire spectrum of the national healthcare system.   That project was never funded by congress, but just last year (June, 2019) Congress voted to appropriate $99 billion dollars to an HHS bill that included creation of a National Patient Identifier.

Ken will review this topic, and oversee a group dialog around the benefits, challenges, and impact related to healthcare and clinical trials.   

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  • Birds-of-a-Feather Round Table Discussion: U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials (8/18/2020 UTC)
    8/18/2020 UTC
    106

    Birds-of-a-Feather Round Table Discussion: U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials

    Presenter/Facilitator:  Ken Light, Clinscape

    In 1996, HIPAA legislation called for the development of a national patient identifier system that would give each person in the United States a permanently assigned, unique number to be used across the entire spectrum of the national healthcare system.   That project was never funded by congress, but just last year (June, 2019) Congress voted to appropriate $99 billion dollars to an HHS bill that included creation of a National Patient Identifier.

    Ken will review this topic, and oversee a group dialog around the benefits, challenges, and impact related to healthcare and clinical trials.   

    Read more
  • eCF Autumn 2020 Virtual Workshop Planned (10/12/2020 - 10/16/2020 UTC)
    10/12/2020 - 10/16/2020 UTC
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    eCF Autumn 2020 Virtual Workshop Planned

    Following the success of our Spring Virtual Workshop (see article below), we are now planning for an Autumn 2020 Virtual Workshop. This will replace face-to-face meetings in Asia, Europe and North America due to continued concern for our members safety during the Covid-19 pandemic. It is our hope that we will be able to resume face-to-face workshops in 2021 as our members have expressed their desire to get back to "getting together" in person once it is appropriate to do that, as they say "nothing can replace the networking and comeraderie of an eCF face-to-face meeting".

    The Autumn 2020 Virtual Workshop will build on our success, learnings, and suggestions for improvement from the Spring Virtual Workshop. We plan to have more interactive sessions, more sessions that are regional-based to allow a better time-of-day for most participants, have some global sessions to allow for the valuable global interaction, and spread it over a full week with a few hours/day. We are currently in the planning stage and welcome suggestions to discussion topics via info@eclinicalforum.org as well as considering all suggestions submitted with the Spring workshop evaluations.

    Please mark your calendars for Oct 12-16 2020 ... and stay tuned for more detailed information as we develop it!

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