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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.
Historically, each sponsor, contract research organization (CRO), clinical site, and eCOA service provider has handled eCOA data change request (DCR) processes differently, resulting in the possibility for mixed expectations among the stakeholders and inconsistent results. In the worst-case scenario, there is the risk of findings from inspections and audits, either because control over source records did not reside as expected with the site, or because there was a lack of oversight over eCOA data changes requested by sites and performed by the eCOA service provider. There is a need for a well-defined, consistent, and balanced process for handling eCOA data change requests in clinical trials. The objective of this document is to outline best practices that will result in improved data accuracy and integrity, greater transparency amongst the different stakeholders, increased consistency throughout the clinical trials industry, and adherence to the study protocol, good clinical practices (GCP), and government regulations. The approach to eCOA data changes outlined here is focused on patient-reported outcome (PRO) data but can be applied, where appropriate, to all eCOA data, including clinician-reported data and observer-reported data.
A collaborative team comprised of Critical Path Institute’s ePRO Consortium, PRO Consortium and eClinical Forum have been meeting since early 2020 to discuss this topic and produce a best-practice recommendations paper. They will be sharing their discussions during this webinar. The associated paper is anticipated to be published during 1Q 2022.
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Submission of comments on EMA’s draft “Guideline on computerised systems and electronic data in clinical trials”
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.
eCF Webinar: Best Practice Recommendations for Changing eCOA Data
eClinical Forum Hybrid Workshop, Barcelona, Spain
We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems
This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.
We encourage you and your colleagues to REGISTER NOW
Download Agenda HERE
Americas Autumn Workshop
eClinical Forum Autumn Workshop, Spring House, Pennsylvania
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Janssen in Spring House, Pennsylvania on October 24-26 2023.
This is an in-person workshop. There will be networking/social events on both evenings. Each eCF Member company in the Americas region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded. Information on the European workshop will be on our website soon.
eClinical Forum Autumn Workshop, Kobe, Japan
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Eli Lilly in Kobe, Japan on November 13-14 2023.
This is an in-person workshop. There will be networking/social events on the first evenings. Each eCF Member company in the APAC region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded.
eCF Technology Showcase: Viedoc Technologies AB – “The integrated eTMF/eISF to control study documentation management”
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Viedoc Technologies, an eClinical Forum member company, will showcase their e-Trial Master File/e-Inestigator Site File solution. The eClinical Forum does not promote nor endorse any particular technology vendors.