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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

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

Public Release PR2023.3

Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)

What expectations do FDA, EMA, PMDA, MNPA, MHRA and ICH put on your e-clinical systems … and how can you easily keep an eye on them as they change?   Happily for you – the eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from these regulatory authorities, and boils them down into 37 statements for you to follow. Each eCF Requirement is “held up” by a series of mappings to the regulatory authority documents. The eCF Requirements can be used to determine if systems that handle data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

The eClinical Forum is releasing this version (V2023.3PR) as a service to the eClinical Community.  This particular version is a significant update from the previous version as it incorporates all the many requirements from the EMA Guideline on computerised systems and electronic data in clinical trials (Effective Sept 2023). The V2024, recently released, is available to eClinical Forum members only. For information on becoming an eClinical Forum member, please see our Membership tab on this website.

This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many 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 around the globe. 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 documents.  If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly. For this reason, the eCF Requirements V2024 is released to eClinical Forum members only, with the V2023.3 now being released to the public.

A free public webinar to discuss how these "eCF Requirements" are being used the industry, will be presented on Sept 18, 2024. For more information: eCF Public Webinar Sept 2024 (eclinicalforum.org)

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Requirements for Electronic Data for Regulated Clinical Trials - "eCF Requirements" past public releases 2018 - 2023

The eCF REG team puts out a yearly version of the "eCF Requirements" which many orgainizations use to check compliance of their systems against regulatory authority document statements. The previous versions have been requested in order to easily check the requirements that were in place in a particular year.

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eCF APAC Autumn Workshop 2024 Announced

eCF APAC Autumn Workshop 2024 Announced

Registration is open!  Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.

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eCF APAC Autumn Workshop 2024 Announced

eCF APAC Autumn Workshop 2024 Announced

Registration is open!  Our APAC Autumn workshop will be kindly hosted by Clario at the Hyatt Regency Tokyo Bayin Urayasu, Japan on November 11-12 2024.

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eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification

eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification

This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions.  The discussion will be around:

  • 100% SDV provides little value for a whole lot of work … but how do we define “critical” data such that not everything is considered critical?
  • How can we implement a risk-based approach without compromising down-stream activities?
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eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

Presenter:        Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)

About this topic:  The final piece of the GCP renovation puzzle, revision 3 of ICH GCP.  Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.

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