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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.
Our grand vision is to set the standard for processes and to make a difference within the clinical trials industry. Being members of the eClinical Forum is a key component in this strategy.
Mats KlaarViedoc Technologies
Through the network of eCF, direct exchange with regulators is possible and allows us to discuss and provide inputs into new guidance.
John SmithBoehringer Ingelheim
The CTU/section for Data Management at Oslo university hospital was approved for certification according to the ECRIN standards in July 2019. One of the tools used for the requirements for data capture tools was the eCF “Requirements for Electronic Data for Regulated Clinical Trials".
Cecilie MoeOslo University Hospital
".. the best use of my time to remain current with what is going on in the industry."
"... a group of professionals that not only recognize and discuss challenges, but actually drive strategic direction"
"... the best, most productive and informative group I have worked with in a long time.."