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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.
On 25-Feb-2020, Kelley Olree of Pfizer and eClinical Forum's eSRA Team, presented a very informative and insightful webinar on “Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool”. One participant sent us a note following the webinar "Let me congratulate you for the eSRA Form and the webcast shared yesterday. I’m pretty sure it will become an international standard."
Kelley has the unique understanding of someone who has worked on clinical trials both from the site side and from the pharmaceutical side. The webinar is one hour long and is full of good information and wisdom. Please click on this link to listen: https://drive.google.com/open?id=1bu_yu-2c45yGiNGtry17QDfSPBFXjtkg
Many have asked for the slides so they are available for download below.
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Birds-of-a-Feather Round Table Discussion: New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data
In July 2020, EMA released a new Q&A to provide further expectations on continuous oversight and frequency of investigators’ signature collection on eCRF data reported to the sponsor. Prior to filing a marketing authorization application, all eCRF data should be signed and dated. But also important data such as that related to reporting of SAEs, adjudication of important events and endpoint data, DSMB review, should be signed off in a timely manner. In addition, a timely review and sign-off of data that are entered directly into the CRF as source is particularly important.
The intent of this webinar is to identify if there are new challenges, and if any – to proceed with an update to the eCF best practices on investigator signatures document that was released in 2017.
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.