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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.
Version 2022.1JP1 (10-May-2022)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2021"
ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements, which 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, NMPA, MHRA 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 systems that 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.
ABOUT THE ECF REQUIREMENTSThe eClinical Forum has updated their set of Requirements, which 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, MHRA, NMPA 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 systems that 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.
Version 2022 (31-March-2022)
This is the ONE FILE that you need to perform an eSRA Assessment.
How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2022)
These comments are provided by a team with representatives from 13 eCF member companies and have been reviewed by the eClinical Forum members. Those on the team are from Sweden, UK, Switzerland, Belgium, Spain, Germany, Italy, United States, and Japan. They represent many hours of personal review/comment as well as 19 hours of team discussion. The larger eCF Membership had opportunity to review and comment as well. The resulting submitted comments (59 pages) are a consensus of member opinion.
The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback. With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool. This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.
The EUCROF and eClinical Forum Electronic Informed Consent (eConsent) Joint Task Force are pleased to announce the publication of the eConsent Implementation Guide (version 1). The joint task force was formed in 2019 with a view to look at some of the barriers to adoption of eConsent considering the benefits to stakeholders.
eConsent offers remote electronic options for informing and consenting trial participants of a clinical trial, this being a particularly useful capability especially during the pandemic period when site visits are reduced.
The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”. This position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.
ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator. The position paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.
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eCF BoF Webinar: Principal Investigator's Signature: Best Practices
The eCF’s PI Signature Working Group have updated their 3-year-old document which is released to eCF Members in early April. They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs). Participants are encouraged to share their thoughts on:
- how to provide continuous monitoring of regulatory expectations;
- sharing members’ experience on implementation and regulatory findings (if any);
- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.
Presenters: eCF PI Signature Team Leaders: Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)
Japanese translation of eSRA V2022
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022
We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022. This hybrid workshop is available for face-to-face or remote participation.
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, New Jersey June 8-10 2022
We are pleased to announce that registration is open for our hybrid workshop at the Old York Cellars in Ringoes, NJ on June 8-10 2022. We are very excited that we can offer this safe and fun venue as we will be meeting in an open-air event tent amidst their beautiful vineyard. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A as well as evening networking events. For those who cannot join in person, some of the sessions will be live-streamed and recorded.