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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: 25/01/2022 - 26/01/2022 Export event
Birds-of-a-Feather Round Table Discussion: Electronic Investigator Site Files (eISF)
Date/Time: Tues 25-Jan-2022 (UTC 16:00) or Wed 26-Jan-2022 (UTC 08:00)
Duration: One hour
Facilitators: Ronit Elstein (Pfizer) Martijn Griep (J&J)
Open To: Staff from eClinical Forum member companies gratis (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )
Background: eClinical Forum webinar sessions focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.
For This Topic: 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. As per eCF policy, Round-table discussions are not recorded.
Webinar A:
Webinar B:
ECLINICAL FORUM MEMBERS CAN FOLLOW THIS LINK TO REGISTER: EISF Round-table Registration (eclinicalforum.org)
Those from companies that are not members of the eClinical Forum -- please let us know your interest via info@eclinicalforum.org and we will be happy to discuss membership options with you.
NOT A MEMBER?
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.