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WHO WE ARE
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: 9/9/2020 - 9/10/2020 Export event
eCF Free Public Webinar: Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)
This webinar will discuss:
What is the Sponsor’s responsibility regarding using data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities?
What are the benefits of all sites and all sponsors and all CROs using a common assessment tool?
What is eSRA?
- Developed by the eClinical Forum, a non-profit, non-commercial discussion/action group comprised of members of the Pharmaceutical and
Clinical Research Services industry, along with sites and academia
- Based on regulatory requirements in EU, US and Japan;
- An assessment tool for clinical research sites to determine if their computer system (EHR, EMR, etc) is appropriate to hold regulated clinical trial data;
- Available for free for over 4 years and currently being used around the globe by many sponsors and thousands of sites;
Japanese translation of eSRA Handbook ;
How a Sponsor/CRO can incorporate eSRA into their processes.
Date/Time: Wed Sep 9 at UTC 0700 (Japan: 1600)
Duration: One hour
Presenter: Kenichi Nakano - eClinical Forum Asia Pacific Facilitator
To register for this free webinar, please follow this link: https://eclinicalforum.org/Forms/ESRA_Japan_9Sep20 --- PLEASE NOTE: WE WILL USE YOUR EMAIL ADDRESS FOR SUPPLYING INFORMATION FOR THIS WEBINAR AND NOT FOR ANY ADVERTISING
NOT A MEMBER?
BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download
The implementation of new solutions to share electronically the eCRF PDFs with sites have brought up new considerations and challenges to this process.
We would like everyone to share their experiences on how the process has been implemented, as well as the challenges experienced. This will be a group discussion on the recommendations to make this process as straight forward as possible for Sites and Sponsors, while complying with requirements.
Facilitated by Carmen Jiménez, Eli Lilly
Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1
The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”. This position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.
ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator. The position paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.
Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent
This webinar introduces the NEW "Practical Guide to eConsent" which addresses key themes and hots topics and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic. This is a joint work by the eClinical Forum and EUCROF.
Birds-of-a-Feather Round Table Discussion: “When does audit trail begin?”
Audit trails create a step-by-step record of data back to its source. It is utilized when the integrity and confidence of the datapoint has critical/legal significance. It is important to determine and declare when data entry becomes “real” data. In legacy paper, data is manually recorded, but only becomes “real” when it is signed, submitted, or completed. Signatures and confirmations also exist to add additional credibility to the source. If a paper form is being filled, it is considered draft until it is declared complete by the originator. The originator has the option to crumple up the “draft” paper and start another without question. The same should hold true with electronic data entry as this webinar will discuss.
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021
We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.
Our virtual workshops in 2020 were a great success and this one will be even better! We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE