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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.
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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 firstname.lastname@example.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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We wish you a Happy New Year 2021
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Birds-of-a-Feather Round Table Discussion: New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data
In July 2020, EMA released a new Q&A to provide further expectations on continuous oversight and frequency of investigators’ signature collection on eCRF data reported to the sponsor. Prior to filing a marketing authorization application, all eCRF data should be signed and dated. But also important data such as that related to reporting of SAEs, adjudication of important events and endpoint data, DSMB review, should be signed off in a timely manner. In addition, a timely review and sign-off of data that are entered directly into the CRF as source is particularly important.
The intent of this webinar is to identify if there are new challenges, and if any – to proceed with an update to the eCF best practices on investigator signatures document that was released in 2017.