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.

 

NEWS FROM THE ECF

Agenda Available… eClinical Forum 2017 Global Meeting,  Reykjavik, Iceland,  May 7-10 2017.

Event Announcement

  • 5/7/2017 6:30 PM - 5/10/2017 2:30 PM
  • Author: Webmaster
  • Number of views: 14662
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Agenda Available… eClinical Forum 2017 Global Meeting,  Reykjavik, Iceland,  May 7-10 2017.
Agenda Available … eClinical Forum 2017 Global Meeting,  Reykjavik, Iceland,  May 7-10 2017. Expand article to see full details, to download documents and to register for the event

Investigator Site Survey .. Please Participate

Partnering for Success

  • 25 January 2017
  • Author: Webmaster
  • Number of views: 21237
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Investigator Site Survey .. Please Participate

The ongoing Investigator Site Survey survey is open to all site staff involved in clinical trials. By participating in this survey, you will help us to better understand the experience and needs of site staff with clinical trial systems and processes. This is not eSRA -- it is a voluntary survey -- it is not an assessment.  (If you are looking for eSRA, please download the Handbook below).  GO TO THE SURVEY. Expand the article to read more...

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

Event Feedback

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event
We had a fabulous level of participation with well over 140 members online from California to Japan participating in our first webinar of 2017 on the release of the addendum to E6 (Good Clinical Practice), 20 years after its original publication. Some good discussion helped us to understand the changes, opportunities and challenges. Expand the article to read more about the event.

eSRA Slides suitable to present to your organization

  • 31 December 2016
  • Author: Webmaster1
  • Number of views: 2520
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eSRA Slides suitable to present to your organization

At recent eCF meetings we have discussed the eSource-Readiness Assessment (eSRA) and the desire that it is used widely by sponsors to assist their sites in assessing the appropriateness of their EHRsystems for providing data for clinical trials. At the eCF meeting at Janssen in Brussels in May 2019, Sumarni Oetringer and Martijn Griep presented a ppt presentation they had created to provide information for J&J … showing how eSRA can be used to save the sponsors and sites a lot of time and effort.  There has been a request to make this ppt deck available to all for use in presenting the case to use eSRA to your organization. Sumarni has modified it so that it is more general and not J&J-specific.

If you are a site and you some of your sponsors are not using eSRA, please pass this presentation on to them. If you are a sponsor or CRO and you are not (yet) using eSRA, please present this to those in your organization who are doing site assessments.

Thanks for spreading the word!  The more organizations that use eSRA, the more efficient and time-saving it becomes for all Sponsors, CROs and Sites.

White Paper, Checklist and Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

  • 22 December 2016
  • Author: Webmaster1
  • Number of views: 49
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White Paper, Checklist and Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers (e.g. EMA Reflection Paper and ICH GCP Addendum). The eCF has engaged with regulators (including the EMA GCP IWG and FDA) and industry stakeholders in developing the documents.

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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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Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent

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.

 

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Birds-of-a-Feather Round Table Discussion:  “When does audit trail begin?”

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.

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