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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.

 

NEWS FROM THE ECF

Requirements for Electronic Data for Regulated Clinical Trials V2018PR

  • 29 March 2019
  • Author: Webmaster1
  • Number of views: 70
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Requirements for Electronic Data for Regulated Clinical Trials V2018PR

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. 

eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

Investigator Site self-assessment of their healthcare systems against clinical research regulations and guidance

  • 25 March 2019
  • Author: Webmaster1
  • Number of views: 1539
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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

We are happy to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. This 2019 version is an update, based on updates to FDA, EMA, PMDA and ICH regulatory documents. We encourage all Sponsors to use this assessment to assist in determining if data that originated in an investigator site system is suitable for inclusion in a clinical trial. We encourage all Investigator Sites to use this assessment tool and provide the resulting report to all Sponsors they are working with, thus avoiding the need to complete different assessments for each Sponsor. Full details of what this valuable tool provides can be found in the eSRA Handbook.

Click on the tab in the top-right of this website (www.eclinicalforum.org) "eSource Readiness Assessment (eSRA)".

Webinar on “Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool”

Recording and slides available

Webinar on “Sponsor responsibility to Assess Investigator Site Systems that may originate source for clinical trials & the free eSRA tool”

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."

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

ENGLISH Version 2020.2

  • 31 January 2019
  • Author: Webmaster1
  • Number of views: 14213
  • 0 Comments
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.

What is the difference between the V2020 and V2019 eSRA?

Changes are minor -- see the list

While several additional regulatory documents were mapped to the eSRA questions, they did not significantly change eSRA between V2019 and V2020. No questions were added or deleted. Some question text were modified to improve clarity. Please download the file showing each question with it's change.

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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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