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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: 18/08/2021 Export event
eCF Focus Session: Audit Trail Review in Practice
Date: Wednesday, 18-August-2021 Duration: Two hours
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 firstname.lastname@example.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: The eClinical Forum published a joint paper with SCDM in April 2021, titled “Audit Trail Review: Key Tool to Ensure Data Integrity”. (If you missed it, you can download it here: Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org) ) Now that members have had time to review the paper and perhaps discuss with colleagues, we thought it is a good time to hear what different members are doing, or are planning to do, regarding audit trail review. This focus session will not be discussing the paper, but rather will be discussing what practices around audit trail review our members are taking.
This is a two-hour focus session. The first hour will be presentations of case-studies, and will also be recorded for those who wish to review at a different time. The second hour will be a round-table discussion and will not be recorded.
First hour: 10-minute case studies
Time – This is a TWO-HOUR Focus session, starting at UTC 1400. We apologize to those who will be viewing it during a non-optimal time. The first hour will be recorded, however the second hour of round-table discussion not be recorded.
Registration is for eClinical Forum members only: Webinar Registration (eclinicalforum.org) Non-members can review information about eClinical Forum membership in the membership tab on this website, or contact us at 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.