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

Announcing Autumn 2019 Meeting Dates

  • 10/28/2019 - 10/31/2019
  • Author: Webmaster1
  • Number of views: 4195
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Announcing Autumn 2019 Meeting Dates

Save the date!!

Oct 14-16 2019 in Peapack, New Jersey USA. Kindly hosted by Pfizer

Oct 28-30 2019 in Zurich, Switzerland EU. Kindly hosted by Business Systems Integration (BSI)

Dec 2-3 2019 in Tokyo, Japan. Kindly hosted by Eli Lilly

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

ENGLISH Version 2020.2

  • 31 January 2019
  • Author: Webmaster1
  • Number of views: 14301
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eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

This is the ONE FILE that you need to perform an eSRA Assessment.

- Sites should complete an eSource-Readiness Assessment (eSRA) to self-assess their healthcare computerized systems (e.g. EHR/EMR) for readiness to originate or handle electronic data that could become part of a clinical research study.

- Sponsors/CROs will find useful information in the Handbook in order to evaluate a completed eSRA from a site, to determine if data that originated in the site's healthcare computerized system complies with clinical research regulations

This Version 2020.2 has had minor updates to clarify the text from V2020. The eSRA questionnaire has not been updated in V2020.2, and will be updated as per the annual schedule and released in March 2021.

- Download the Handbook file and save to your computer. The instructions are in section 3 and the assessment is in section 5. Sites should complete the assessment and email it to their sponsors.

Click on title to get to the download screen.

AUDIT TRAIL REVIEW

  • 29 January 2019
  • Author: Webmaster1
  • Number of views: 108
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AUDIT TRAIL REVIEW

Best practices for meeting regulatory expectations for Audit Trail Review

Archiving and Decommissioning

Developing a position paper from the industry on the electronic archiving of study data and related topics

  • 29 January 2019
  • Author: Webmaster1
  • Number of views: 99
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Archiving and Decommissioning

Developing a position paper from the industry on the electronic archiving of study data and related topics

Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

Release 2020

  • 24 January 2019
  • Author: Webmaster1
  • Number of views: 4717
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Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

eCF eSRA Release 2020 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan), CMPS (China) and ICH (International). The eClinical Forum will continue to monitor new releases and updates of regulatory documents from these agencies to determine if the eSRA template questions should be updated.

Click on document title to download.

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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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