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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.
Event date: 01/12/2020 Export event
Technology Showcase: Target Health – Challenges to the Adoption of Paperless Trials During the COVID-19 Epidemic and Beyond
Open To: Staff from eClinical Forum member companies. For information on eCF membership, please see www.eclinicalforum.org/membership or send an inquiry to email@example.com.
Background: 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. For more information, please reply to firstname.lastname@example.org.
Presenter: Dr. Jules Mitchel, Target Health
About this Topic: Clearly, the implementation of traditional clinical research studies as well as executing COVID-19 studies themselves. have been dramatically impacted by global COVID-19 pandemic. Since showing up at clinical sites in general is becoming less feasible, clinical research must adapt. While there are many exciting ideas to execute virtual and remote studies, the focus still needs to be on the assurances that 1. the clinical sites understand and are following the protocol; 2. the data can and are being entered and reviewed in “real time,” 3. there are the “absence of errors that matter” and 4. the “data are fit for purpose.” This session will showcase several studies using a web-based application, with Informed Consent fully integrated with real time direct data capture, real time reports, online monitoring reports and safety reporting.
Date: Tues, December 1 2020 Duration: One hour
Time: Webinar at UTC 1500. This webinar will also be recorded so that all eCF Asia-Pacific members and other members who have time conflicts can review at a more convenient time. Please also register if you are interested in the recording.
eClinical Forum Membership registration: https://eclinicalforum.org/Forms/TS-Paperless-Trials
Non-members: Please review membership information on this website in the membership tab, or contact us for more information: email@example.com
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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)
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)
eCF Technology Showcase: Veeva CDB - Creating a Foundation for Digital Trial Data / Decentralized Trials
Conducting decentralized trials is an important pathway to improving patient centricity, yet they create painful data management challenges that increase costs and delay access to reliable data. As companies move toward digital trials, the number and variety of data sources grows, and visibility into your data declines. Most modern trial designs, including adaptive trials, need interim analyses which require timely access to reliable data. In this technology showcase, Veeva will share their clinical database, Veeva CDB, and demonstrate how it produces a complete and concurrent view of the clinical data. Decentralized trials run better with centralized data management that can speed database locks and support better decision-making during study conduct.
eCF 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.