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

Release 2021

  • 1 March 2021
  • Author: Webmaster1
  • Number of views: 6007
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Regulatory documents used as a basis for the eClinical Forum eSource Readiness Assessment (eSRA)

eCF eSRA Release 2021 is based on regulatory documents from FDA (USA), EMA (European Union), PMDA (Japan), CMPS (China), MHRA (UK) 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.

Disclaimer:The information presented in these works draws upon the combined understanding and knowledge of the eClinical Forum and is provided as an aid to understanding the environment for electronic clinical research. The opinions of the author(s) and the eClinical Forum do not necessarily reflect the position of individual companies.The content is unconfirmed and users should assess the content and opinions in the light of their own knowledge, needs and experience as well as interpretation of relevant guidance and regulations.

Creative Commons License These works are licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License

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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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