"This is the best use of my time to remain current with what is going on in the industry."
This 13-page position paper on eSource (source data that has been captured by an electronic tool which is a replacement for paper) describes the regulatory environment for the ultimate benefit of all stakeholders involved in EDC.
eSource has been selected as a priority because of recently conducted surveys on the impact of EDC on Investigational sites. These surveys have revealed that the workload at sites using EDC may increase, despite the easier data entry that is being reported. The reason is linked to dissatisfaction with the multiple data entry being demanded due in part to the lack of clarity on the level of acceptance of eSource. For example, where patient data are being recorded in legitimate clinic electronic source records before being entered into the sponsor’s EDC system, some sponsors appear to be demanding the creation of additional paper records to act as source for the purposes of Source Data verification.
The position paper regarding eSource presents the general consensus of the EDM Forum rather than individual organisations. The paper was prepared as a response to ‘Draft Guidance for Industry: Part 11, Electronic Records, Electronic Signatures – Scope and Application’ in the expectation that the clarification of electronic source data would strongly support adoption of electronic technologies and reduce the cost of current EDC implementations.
Thes position paper details:
eCF Views & News
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(21/10/2025 - 23/10/2025)
(04/11/2025 - 06/11/2025)
(04/11/2025 13:00 - 06/11/2025 15:00)
eCF Autumn Workshops Announced!
We are happy to announce our 3 Autumn workshops!
Americas: Hosted by Eli Lilly in Indianapolis on October 21-23
Europe/Hybrid: Hosted by Medidata in London on Nov 4-6 (this will be livestreamed as well)
Asia: Hosted by Kyowa Kyrin in Tokyo on Nov 13-14
Registration for the eCF Europe Autumn Hybrid Workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Medidata in London, UK, on November 4-6, 2025
The workshop will be available for both in-person participation and remote access. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 in-person seats depending on your membership type and as allocated by your eCF Primary Representative. Remote access of the live-streamed workshop is available gratis to all staff from eCF Member companies. Click to get more information on the planned topics.
Registration for the eCF Asia Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.
The workshop will be available for in-person participation only. There will be a networking/social event in the evening. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here
Technology Showcase: eClinical Solutions: elluminate Assist – AI-driven SDTM study data analysis assistant
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, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors. Any member can participate that has an interest in the topic area. Any eClinical Forum Member may suggest or present a Technology Showcase. READ MORE for details on this Technology Showcase.