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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.

 

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MEMBERS...Materials from Webinar: “Practical Considerations when implementing eConsent"

Tuesday, 10-March-2021 at UTC 09:00 and UTC 16:00

  • 17 February 2021
  • Author: Webmaster1
  • Number of views: 226
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MEMBERS...Materials from Webinar:  “Practical Considerations when implementing eConsent"

This webinar introduces the eCF and EUCROF Implementation 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.

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«February 2021»
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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

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.

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MEMBERS...Materials from Webinar:  “Practical Considerations when implementing eConsent"

MEMBERS...Materials from Webinar: “Practical Considerations when implementing eConsent"

This webinar introduces the eCF and EUCROF Implementation 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.

Read more
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BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

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

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Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

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.

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Principal Investigators’ Signatures

Principal Investigators’ Signatures

Aligning the existing eCF best practices document with the most recent regulatory expectations

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