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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: 14/07/2021 Export event
eCF Webinar: FDA OneSource and Common Data Model Harmonization (CDMH) -- Use of Real World Data in Clinical Research
Date: 14-July-2021 Duration: One hour
Presenter: Mitra Rocca, Senior Medical Informatician, FDA CDER Health Information Technology Lead
FDA, CDER, Office of Translational Sciences
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 email@example.com )
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.
For This Topic: In this webinar, two of CDER-led RWD projects will be presented:
1.The OneSource Project is a collaboration between investigators at the University of California San Francisco (UCSF) and the FDA with the goal of developing methods to automate the flow of structured Electronic Health Record (EHR) data into clinical trial electronic data capture (EDC) systems thereby reducing operating costs, saving time, and improving data quality for clinical trials.
2. The Common Data Model Harmonization (CDMH) project is led by FDA CDER in collaboration with NIH. The goal of this project is to harmonize several common data models (CDMs) to generate evidence. In this webinar the CDMH accomplishments in phase I and ongoing activities for phase II will be presented.
Time: UTC 14:00 (California 7am / NYC 10am / London 2pm / Brussels 3pm / India 7:30pm / Singapore 10pm / Japan 11pm)
eCF Members should use this link to register: Webinar Registration (eclinicalforum.org)
If you are not an eCF member, please review the membership tab on this website for information on becoming a member.
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eCF BoF Webinar: Principal Investigator's Signature: Best Practices
The eCF’s PI Signature Working Group have updated their 3-year-old document which is released to eCF Members in early April. They will introduce the 2022 changes to the best practice document for Investigator’s signature on electronic Case Report Forms (eCRFs). Participants are encouraged to share their thoughts on:
- how to provide continuous monitoring of regulatory expectations;
- sharing members’ experience on implementation and regulatory findings (if any);
- brainstorming for an industry definition of the “meaning” of signature on data reported to sponsors during both traditional and non-traditional clinical trials.
Presenters: eCF PI Signature Team Leaders: Cinzia Piccinia (Eli Lilly) and Babette von Hagen (CSL Behring)
Japanese translation of eSRA V2022
Version 2022.1JP1 (10-May-2022)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, Brussels May 17-19 2022
We are pleased to announce that registration is now open for our next European Workshop at the Crowne Plaza Brussels Airport, Brussels on 17-19 May 2022.
This hybrid workshop is available for face-to-face or remote participation.
REGISTRATION OPEN: eClinical Forum Hybrid Workshop, New Jersey June 8-10 2022
We are pleased to announce that registration is open for our hybrid workshop at the Old York Cellars in Ringoes, NJ on June 8-10 2022. We are very excited that we can offer this safe and fun venue as we will be meeting in an open-air event tent amidst their beautiful vineyard. Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange, contribution to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A as well as evening networking events. For those who cannot join in person, some of the sessions will be live-streamed and recorded.