"This is the best use of my time to remain current with what is going on in the industry."
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.
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, 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.
Release of 2019 eCF Requirements Document for Public Use
The V2019PR document (mapped to 21 regulatory documents; an update of 7 documents from V2018) is being released to the public as we believe that it will be of significant use to all.
The eCF Requirements V2019PR can be downloaded from this website in the Downloads area.
The eCF has also produced an assessment tool, 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.
At this time, the 2020 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 V2020), please see membership details at www.eclinicalforum.org/membership or send us a note at info@eclinicalforum.org 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 REG absolutely welcomes feedback. Please send feedback to REG@eclinicalforum.org
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BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download
The implementation of new solutions to share electronically the eCRF PDFs with sites have brought up new considerations and challenges to this process.
We would like everyone to share their experiences on how the process has been implemented, as well as the challenges experienced. This will be a group discussion on the recommendations to make this process as straight forward as possible for Sites and Sponsors, while complying with requirements.
Facilitated by Carmen Jiménez, Eli Lilly
Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1
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.
Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent
This webinar introduces the NEW "Practical Guide to eConsent" which addresses key themes and hots topics and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic. This is a joint work by the eClinical Forum and EUCROF.
Birds-of-a-Feather Round Table Discussion: “When does audit trail begin?”
Audit trails create a step-by-step record of data back to its source. It is utilized when the integrity and confidence of the datapoint has critical/legal significance. It is important to determine and declare when data entry becomes “real” data. In legacy paper, data is manually recorded, but only becomes “real” when it is signed, submitted, or completed. Signatures and confirmations also exist to add additional credibility to the source. If a paper form is being filled, it is considered draft until it is declared complete by the originator. The originator has the option to crumple up the “draft” paper and start another without question. The same should hold true with electronic data entry as this webinar will discuss.
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021
We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.
Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE