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

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

Requirements for Regulated Electronic Data in Clinical Trials and the Site eSource-Readiness Assessment

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

The eClinical Forum is pleased to offer a recording of our free public webinar – the same as was presented to the FDA CDER Health IT Board on 6-April-2021 – to provide information on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).This public webinar was given on 28-April-2021 to over 250 registrants worldwide. 

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

  • 15 March 2021
  • Author: Webmaster1
  • Number of views: 17463
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eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

Version 2021

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

Implementing eSRA: Sponsor Perspective

Implementing eSRA: Sponsor Perspective

How to assess site's systems for appropriateness of collecting data for regulated clinical research. (Version 2021)

What is the difference between the eSRA 2020 and eSRA 2021?

What is the difference between the eSRA 2020 and eSRA 2021?

JAPANESE TRANSLATION of eSRA Handbook and Webinar

eSRA Version 2021

JAPANESE TRANSLATION of eSRA Handbook and Webinar

This is the 2021JP1 version.

Example of a completed eSRA V2021

Example of a completed eSRA V2021

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

Release 2021

  • 1 March 2021
  • Author: Webmaster1
  • Number of views: 6005
  • 0 Comments
Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

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

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

Recording and slides available

RESULTS: Investigator Site Survey

Partnering for Success

  • 31 October 2019
  • Author: Webmaster
  • Number of views: 22352
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RESULTS: Investigator Site Survey

544 responses were received to the Site Survey between 26 April 2016 and 5 August 2019. After removing 16 responses with no clinical trial experience, 528 responses were retained for analysis, Results of the survey are presented in the attached download together with comparison with 2009 results where appropriate. The intention is to post further analyses by time period and region.

Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

  • 1 October 2019
  • Author: Webmaster1
  • Number of views: 5376
  • 0 Comments
Prominent Industry Magazines address the need for investigator site systems assessment and eSRA

Applied Clinical Trials (English, December 2018)

PHARMSTAGE (Japanese, October 2019)

eSRA Slides suitable to present to your organization

  • 15 July 2019
  • Author: Webmaster1
  • Number of views: 3447
  • 0 Comments
eSRA Slides suitable to present to your organization

eSRA Maintenance

Self-Evaluating the GCP Compliance of Systems Holding Source Data

  • 1 March 2018
  • Author: Webmaster1
  • Number of views: 1018
  • 0 Comments
eSRA Maintenance
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MEMBERS...Recordings Now Available | ICH E6 Guideline for  Good Clinical Practice (GPC) – Update on Progress

MEMBERS...Recordings Now Available | ICH E6 Guideline for Good Clinical Practice (GPC) – Update on Progress

Recordings Now Available | ICH E6 Guideline for Good Clinical Practice (GPC) – Update on Progress 

...public web conference, "ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress," that was held on May 18 & 19 and organized by the International Council for Harmonisation (ICH) and convened by the Clinical Trials Transformation Initiative (CTTI).

...listen to the web conference recordings, view the slides of the full presentations, and watch this video about the ICH guideline development process. 

To stay up to date on the work to revise ICH E6, please visit the ICH web page.

VISIT THE ECF MEMBER DISCUSSION ON ICH E6 R3

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eCF BoF Round-table: Utilization of Scribes for eCOA

eCF BoF Round-table: Utilization of Scribes for eCOA

This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. We will be discussing “The utilization of scribes is needed for the conduct of clinical assessments within eCOA.  Therefore, eCOA needs to be built in a manner that meets the regulatory requirements for scribing, to ensure all individuals participating in the assessment are audit trailed.”

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"When should audit trail begin?"

"When should audit trail begin?"

Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?"  It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.

Link to article:  When Should the Audit Trail Begin? (appliedclinicaltrialsonline.com) 

We welcome feedback! Please send to: REG@eclinicalforum.org 

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