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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: 08/07/2020 Export event
Birds-of-a-Feather Webinar: Real-world data (RWD) and real-world evidence (RWE)
Date: Recordedm -- July 2020 Duration: One hour
Facilitators: David B. Stein, Independent eClinical Consultant, D. Bartley Consulting, and Jordi Gago, Digital Scientist, Boehringer Ingelheim
Open To: While eCF events are typically only available gratis to eCF members, we are providing this valuable webinar to non-members as well as a way of saying "Welcome! We'd like to have you join us!" Please send an email with your name and organization to email@example.com for access to this recording.
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 keep the subject on track and prompt discussion and information sharing.
For This Topic:
According to the FDA’s website, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.” And a recent survey by the eClinical Forum showed that most respondents believe that RWD and RWE will become much more important in clinical research over the next few years. As a result, many questions have arisen regarding the use cases, data sources, quality of these sources, regulatory guidance documents and so on.
The goal of this “Birds of a Feather” session is to present some basic information on these topics and to present a few case examples to illustrate how RWD and RWE are playing an increasingly important role in research. The agenda is as follows:
Registration: While eCF events are typically only available gratis to eCF members, we are providing this valuable webinar to non-members as well as a way of saying "Welcome! We'd like to have you join us!" Please send an email with your name and organization to firstname.lastname@example.org for access to this recording.
NOT A MEMBER?
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.