"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 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 The paper was prepared as a response to ‘Draft Guidance for Industry: Part 11, Electronic Records, Electronic Signatures – Scope and Application’ in the expectation that the clarification of electronic source data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:
NOT A MEMBER?
eCF Technology Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention
AiCure, and eCF member company will present how their software uses AI to improve patient adherence, compliance, and retention.
The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.
eCF Spring 2025 Workshops Announced
We are pleased to announce our 2025 Spring Workshops.
These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.
April 8-10: Bangalore, India (kindly hosted by i2e)
April 29-May 1: King-of-Prussia, PA, USA (kindly hosted by CSL Behring)
May 13-15: Walton Oaks, Surrey, UK (kindly hosted by Pfizer)