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  • Virtual Workshop 12-16 October 2020
    Virtual Workshop 12-16 October 2020
  • Virtual Global Workshop 11-13 May 2020
    Virtual Global Workshop 11-13 May 2020
  • Tokyo 2-3 December 2019
    Tokyo 2-3 December 2019
  • Zurich 28-30 October 2019
    Zurich 28-30 October 2019
  • Peapack 14-16 October 2019
    Peapack 14-16 October 2019
  • Brussels 15-17 May 2019
    Brussels 15-17 May 2019
  • Danbury 8-10 April 2019
    Danbury 8-10 April 2019

WHO WE ARE

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

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Implementing eSRA: Sponsor Perspective

Implementing eSRA: Sponsor Perspective

This document is written specifically for Sponsors to assist them in determining how to fit eCF's eSource-Readiness Assessment (eSRA) into their procedures for determining if data which originated on a  site's electronic health record system is suitable for use in their clinical trial. It shows the benefits of using a common assessment tool, provides suggestions for implementing eSRA, and shows a mapping of eSRA questions to regulatory authority statements/expectations.

2020 is our 20th Anniversary Year!

2020 is our 20th Anniversary Year!

A lot has happened in electronic support for clinical research in the last 20 years ... and eClinical Forum has been there discussing it all!  We are pleased to be celebrating our 20th anniversary year, stronger than ever with 45+ member companies (and growing), meetings on 3 continents, global webinars that have been attended by members in over 25 countries, very active project teams, meetings with regulators, and freely adding to the knowledge base of the industry. Any organization working in this space is welcome to join. Please see the membership tab on our website (www.eclinicalforum.org) or contact us for more information!  info@eclinicalforum.org

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.

 

eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More

Sept 25, 2019 presented by Jill Platko and Miko Pietila of Signant Health

eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More

Electronic solutions for patient-reported and clinician-reported outcomes provide rich metadata that can be mined for additional insights describing trial performance and driving risk-based monitoring. We will explore the use of this eCOA meta data in fraud detection, and other analytics insights and how these data might translate to risk indices to inform risk-based monitoring activities.

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .  July 8, 2019

The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial

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Free Public Webinar: Assessment of Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

eSRA (eSource Readiness Assessment) is a tool to assess the data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities. eClinical Forum issued a Japanese translation of eSRA Handbook in July.  This seminar is targeted for Japanese audiences, and eSRA will be explained in Japanese.
eSRA (eSource Readiness Assessment)はEHR/EMRなどの医療機関のシステムのデータを治験に利用できるかどうか評価するためのツールであり、7月にeSRA Handbookの日本語版がリリースされました。本Webinarは日本の方を対象にeSRAをご紹介するものです。ぜひご参加をお待ちしています。

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BoF Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity

Join us for a discussion of the eCF/SCDM industry position paper on the use of audit trail review as a key tool in ensuring data integrity.   We will share our thoughts on the rationale, opportunities and challenges, along with practical implementation recommendations.  

Presenters:           Linda King, Astellas, eCF Audit Trail Review Team

                                Miko Pietilä, Signant Health, eCF Audit Trail Review Team

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Upcoming events Events RSSiCalendar export

  • DETAILED AGENDA: eClinical Forum Virtual Workshop, 12-16 October 2020 (10/12/2020 - 10/16/2020 UTC)
    10/12/2020 - 10/16/2020 UTC
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    DETAILED AGENDA: eClinical Forum Virtual Workshop, 12-16 October 2020

    We are pleased to announce the details of our next Virtual Global Workshop on 12-16 October 2020 (which replaces our planned Global Workshop in Dublin which is postponed until 2021). The virtual workshop will include a mix of global and regional events and is open to participants from any member company in any region.

    Our last virtual workshop was a great success and this one will be even better. We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of global sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

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