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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.
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.
Aligning the existing eCF best practices document with the most recent regulatory expectations
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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The eClinical Forum website was disabled for a while because of a ransomware attack at our hosting company. We apologise for any inconvenience that this might have caused.
We have succeeded in restoring the site to a new server and it is now available again for general use. We are still in the process of testing and reconfiguring the site and so some aspects may not work at expected. We ask for your patience while we bring everything back online.
If you do encounter problems and need to contact us, then we are always available at...
firstname.lastname@example.org for eSRA related questions
email@example.com for webinar registrations and questions
firstname.lastname@example.org for membership and general enquiries
The eClinical Forum is a peer networking group run by its members for its members. Our newsletter provides important information and facts about the eClinical Forum. Read about the philosophy and objectives of the group, the eCF community and the work it has done, the teams that are active and what our members say. There is nothing quite like the eClinical Forum.
We have recently learnt that fraudulent Emails have been sent out with eclinicalforum.org addresses. The security issue has now been fixed, however, please be vigilant if you have received Emails during April and May purportedly from the eClinical Forum if they are asking for payment or personal information.
Please don’t hesitate to contact us at email@example.com if you have any questions or concerns.
The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR” 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.
A lot has happened in electronic support for clinical research in the last 20 years ... and eClinical Forum has been there discussing it all! We are pleased to be celebrating our 20th anniversary year, stronger than ever with 45+ member companies (and growing), meetings on 3 continents, global webinars that have been attended by members in over 25 countries, very active project teams, meetings with regulators, and freely adding to the knowledge base of the industry. Any organization working in this space is welcome to join. Please see the membership tab on our website (www.eclinicalforum.org) or contact us for more information! firstname.lastname@example.org
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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
Version 2022.1JP1 (10-May-2022)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
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.