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

eCF Members Release 25-March-2019

  • 27 April 2018
  • Author: Webmaster1
  • Number of views: 5059
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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«August 2021»
eCF Focus Session:  Audit Trail Review in Practice

eCF Focus Session:  Audit Trail Review in Practice

The eClinical Forum published a joint paper with SCDM in April 2021, titled “Audit Trail Review: Key Tool to Ensure Data Integrity”.  (If you missed it, you can download it here: Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org) )  Now that members have had time to review the paper and perhaps discuss with colleagues, we thought it is a good time to hear what different members are doing, or are planning to do, regarding audit trail review. This focus session will not be discussing the paper, but rather will be discussing what practices around audit trail review our members are taking.

This is a two-hour focus session. The first hour will be presentations of case-studies from eClinical Forum members. The second hour will be a round-table discussion.

Read more

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