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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 round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing challenges Sponsor companies are having evaluating, monitoring and documenting a site’s eISF, and to share best practices, challenges, and ideas.
Facilitators: Ronit Elstein (Pfizer, US) Martijn Griep (Janssen, Belgium)
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eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.
We will be discussing a recent eCF/EUCROF positions paper:
The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities. Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper. You can download the position paper here: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)
eCF Round-table: Electronic Investigator Site Files (eISF)
(25/01/2022 - 26/01/2022)
Birds-of-a-Feather Round Table Discussion: Measuring Clinical Trial Data Quality
We will be discussing the general GCP expectations to perform “Quality control” to each stage of trial data handling to ensure that all data are reliable and has been processed correctly. This single statement has very broad interpretations and in this session we can enable the discuss focused the application over Clinical Data Management.
eCF Technology Showcase: Clinical ink - "Tying Passive Data Collection to Active Mobile Measurements"
This technology showcase will present how to unlock the value of passive data collection in clinical research by tying the rich, voluminous patient data compiled by mobile sensors and wearables to active mobile measurements.
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Uppsala Sweden 4-6 October 2022
We are pleased to announce that registration is now open for our next European Workshop kindly hosted by Viedoc Technologies at their premises in Uppsala, Sweden, on 4-6 October 2022.
This hybrid workshop is available for face-to-face or remote participation.
Please note... Not all of the sessions will be available for remote participation. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can
eClinical Forum Americas Workshop
This meeting is kindly hosted by Merck at their Training Facility in North Wales, PA. We are currently accepting suggestions for agenda topics and/or presenters in the areas of Decentralized Clinical Trials, Real World Evidence, Digital Health Technologies, Trends in Clinical Research, AI/ML case studies, Regulatory Updates, and Emerging Roles/Responsibilities.