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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

What is the difference between the eSRA 2020 and eSRA 2021?

What is the difference between the eSRA 2020 and eSRA 2021?

What is the difference between the eSRA Version 2021 and eSRA Version 2020?

The eClinical Forum eSRA Team spent considerable time evaluating each eSRA question to determine updates for the 2021 version. These updates are based on:

  • Updates and additions to the underlying regulatory authority documents as identified by the eClinical Forum Regulatory Advisory Group. A mapping between eSRA questions and eCF Requirements are in the document “Implementing eSRA: Sponsor Perspective”. Complete details of the eCF Requirements, including mapping to regulatory documents can be downloaded from www.eclinicalforum.org/downloads.
  • A desire to make the questions more concise and clear – based on feedback from users
  • Reduction of redundancy by combining some questions

What sites should complete an eSRA V2021?

  • All new sites
  • If a site with an existing completed eSRA updates their system to a new version
  • Sponsors should review differences between eSRA V2020 and eSRA V2021 to determine if they deem it significant enough to ask for existing sites to update

We are committed to continuing to improve eSRA. Please provide feedback via email to eSRA@eclinicalforum.org.

Please download to see the comparison of each eSRA question to the previous year's eSRA question.

Documents to download

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HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022

HOLD THE DATES: eClinical Forum Hybrid Workshops, Sweden, Japan and United States October/November 2022

We are pleased to announce our next Workshops:

- Europe: Uppsala, Sweden on 4-6 October 2022 kindly hosted by Viedoc Technologies

- Asia-Pacific: Tokyo, Japan on 25-26 October 2022 kindly hosted by Bristol-Myers Squibb

- Americas: North Wales, Pennsylvania on 14-16 November 2022 kindly hosted by Merck & Co.

The workshops will be available for face-to-face and remote participation. We will soon be in touch with registration details but in the meantime please save the dates in your calendar.

We are building exciting agendas for the meetings. If you can contribute or have topics to propose, then please get in touch.

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Views & News -- August 2022

Views & News -- August 2022

We send a monthly email newsletter to our members to keep them abreast of eCF Views (items on our online members-only discussion board) and eCF News (upcoming events, activities of our project teams, etc). If you would like to be included in the monthly e-newsletter mailing, please send a note to Webmaster3@eclinicalforum.org.   Click "Read More" to see this month's "Views & News"!

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eClinical Forum APAC Workshop

eClinical Forum APAC Workshop

This meeting is kindly hosted by Bristol Myers Squibb and held in a facility near the Tokyo Station.  We are currently accepting suggestions for agenda topics and/or presenters in the areas of  Decentralized Clinical Trials, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.

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Birds-of-a-Feather Round Table Discussion:  Measuring Clinical Trial Data Quality

Birds-of-a-Feather Round Table Discussion: Measuring Clinical Trial Data Quality

We will be discussing the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management.

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