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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 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.
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 FDA, EMA, PMDA, NMPA, MHRA 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.
This release, PR2021 is for Public Use
The V2021PR document (mapped to 32 regulatory documents; an update of 9 documents from V2020) is being released to the public as we believe that it will be of significant use to all.
At this time, the 2022 Version of the eCF Requirements is reserved for eClinical Forum members only. For information on becoming an eClinical Forum member (and thus having access to the eCF Requirements V2022, which are mapped to 38 regulatory authority documents), please see membership details at www.eclinicalforum.org/membership or send us a note at email@example.com and we will be happy to set up a phone meeting to discuss all the benefits that come to an organization through membership. Please note – membership is by organization only; there are no individual membership options.
The eCF has also produced a questionnaire, based on the eCF Requirements, that can be used for sites to assess if their EHR/EMR systems are suitable for originating data that could be used in a regulated clinical trial. This tool is called “eSRA” for “eSource-Readiness Assessment” and can be downloaded from the eClinical Forum website in the eSRA tab.
The eCF REG absolutely welcomes feedback. Please send feedback to REG@eclinicalforum.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.