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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

eCF "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022

Select recordings available

eCF "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022

“Birds-of-a-Feather” Webinars are provided monthly, to get those with similar interests together.  Anyone from an eCF member company (around the globe!) can participate, gratis. All eCF members can suggest a topic and/or lead a discussion.

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

Requirements for Regulated Electronic Data in Clinical Trials and the Site eSource-Readiness Assessment

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021

Recording: Use of eSRA to fulfill Sponsor responsiblity for assessing site systems

Recording: Use of eSRA to fulfill Sponsor responsiblity for assessing site systems

Birds-of-a-Feather Webinar & Discussion: Investigator Oversight on eCOA data - what is a good evidence?

January 29 2020; facilitated by Cinzia Piccini of Eli Lilly

Birds-of-a-Feather Webinar & Discussion:  Investigator Oversight on eCOA data - what is a good evidence?

As there are no regulatory detailed expectations on oversight by investigators on eCOA data, multiple approaches have been adopted across the industry (from log-in as evidence to notification/alerts or investigator signature on eCOA data). In general, as per other data sources, oversight for eCOA data should be continual and not once at the end of the study. In addition, oversight activities should be right-sized according to the criticality of the data and protocol requirements for compliance. Evidence of the oversight should be available during the conduct of the trial and enduring for the entire retention period.  The aim of this webinar is to allow participants to share different approaches and any knowledge of current expectations by regulatory inspectors.

 

MEMBERS: Birds-of-a-Feather and Tech Showcase Recordings

  • 25 July 2017
  • Author: Webmaster1
  • Number of views: 1
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Selected events are recorded and are available un-edited for member use only within the "BoF & TS Recordings" folder below.  Not all events will be recorded or released. Recordings are un-edited and are provided for eCF member use only.  Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors.

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

Event Feedback

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event
We had a fabulous level of participation with well over 140 members online from California to Japan participating in our first webinar of 2017 on the release of the addendum to E6 (Good Clinical Practice), 20 years after its original publication. Some good discussion helped us to understand the changes, opportunities and challenges. Expand the article to read more about the event.

Electronic Informed Consent Technology Showcase - An Excellent Event

Event Feedback

  • 30 November 2016
  • Author: Webmaster
  • Number of views: 14583
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Electronic Informed Consent Technology Showcase - An Excellent Event

We had a fabulous level of participation with well over 50 members online from California to Japan participating in our Technology Showcase exploring electronic informed consent and demonstrating Enforme Interactive/Drug Dev’s SecureConsent Application for eICF. Some good discussion helped us to understand the business opportunities and value. Materials are available for download. Expand the article to read more about the event.

Adoption of Cloud Technology in the Regulated Life Sciences Industry

An eCF BoF Webinar presented by PhUSE

  • 27 September 2016
  • Author: Webmaster
  • Number of views: 12617
  • 0 Comments
Adoption of Cloud Technology in the Regulated Life Sciences Industry
PhUSE kindly presented their framework for the adoption of cloud technology in the regulated life sciences industry. The session was attended by 70 members from 24 companies in 14 countries. Expand the article to read more about the topic and discussion

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Public Release: English Translation of V2.00 of Japan EDC Management Sheet

Public Release: English Translation of V2.00 of Japan EDC Management Sheet

The Regulatory Expert Group is happy to announce the release of the English translation of the JPMA EDC Management Sheet v2.00.  EDC Management Sheet is a tool by which Japan Pharmaceuticals and Medical Devices Agency (PMDA) ensures  the computerized system used in clinical trials comply with relevant regulations and guidelines.This is an unofficial translation and made public for anyone to use. Please be advised that the original Japanese version should be used for any disputes.

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