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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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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

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

eCF Members Release 25-March-2019

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

The eClinical Forum is happy to announce the V2019 Members-Only release of the “eCF Requirements”. 

The eCF Requirements are based upon statements in regulatory documents 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.  We have reviewed regulatory documents from the FDA, EMA, PMDA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if data which will become part of a regulated clinical trial are consistent with regulatory requirements. The V2019 Members Release has 21 documents mapped.

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ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

  • 15 June 2017
  • Author: Webmaster
  • Number of views: 11333
  • 0 Comments
ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation…  Expand article to read more...

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: 14106
  • 0 Comments
FDA and OHRP Issue Final Guidance on the Use of Electronic Informed Consent 12/15/2016

The FDA and 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. Expand the article to read more

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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
    103

    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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