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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.


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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 Members-Only release of the “eCF Requirements” V2019.

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 eCF Requirements are being released to eCF Members Only.  This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over several years to be able to produce such a comprehensive list of compliance requirements for evaluating electronic systems that will manage data used in regulated clinical research against regulations and guidances from 21 different documents from FDA, EMA, PMDA and ICH.  This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. They have spent hours debating each regulation or guidance and how to word the eCF Requirements to correctly meet the needs in the regulatory document.  If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly. For this reason this document is for eClinical Forum members only.  

eCF has also released a Public Version of this document -- showing the 14 regulatory documents mapped to the 2018 version. This is available to anyone through the Downloads tab of this website.

If you are not a member and would like information about membership, please see the Membership tab on this website and/or contact us via info@eclinicalforum.org and we will be happy to set up a time to talk to you about what we do, membership options, and answer your questions.

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9/9/2020 UTC
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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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9/23/2020 UTC
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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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