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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

"When should audit trail begin?"

eCF published in Applied Clinical Trials 16-June-2021

"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 

eCF Webinar:  FDA OneSource and Common Data Model Harmonization (CDMH)

Wed, 14-July-2021

eCF Webinar:  FDA OneSource and Common Data Model Harmonization (CDMH)

eCF Webinar:  FDA OneSource and Common Data Model Harmonization (CDMH) - Use of Real World Data in Clinical Research

Presenter:   Mitra Rocca, FDA CDER Health Information Technology Technical Lead

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )

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. 

Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

An Industry Position Paper

Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0

The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback.  With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool.  This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.

eSRA (eSource Readiness Assessment) Handbook and Assessment Questionnaire

  • 15 March 2021
  • Author: Webmaster1
  • Number of views: 17464
  • 0 Comments
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)

JAPANESE TRANSLATION of eSRA Handbook and Webinar

eSRA Version 2021

JAPANESE TRANSLATION of eSRA Handbook and Webinar

This is the 2021JP1 version.

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"

V2019PR March 2020

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR”.

ABOUT THE ECF REQUIREMENTSThe 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.  We have reviewed regulatory documents from the FDA, EMA, PMDA, and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems that data which will become part of a regulated clinical trial are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

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)

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .  July 8, 2019

The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) 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

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

eCF Members Release 25-March-2019

  • 27 April 2018
  • Author: Webmaster1
  • Number of views: 4836
  • 0 Comments
Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

The eClinical Forum is happy to announce the V2019 Members-Only release of the “eCF Requirements”. 

The eCF Requirements 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.  We have reviewed regulatory documents from the FDA, EMA, PMDA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if data which will become part of a regulated clinical trial are consistent with regulatory requirements. The V2019 Members Release has 21 documents mapped.

Click title for more information

ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

  • 15 June 2017
  • Author: Webmaster
  • Number of views: 12368
  • 0 Comments
ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation…  Expand article to read more...

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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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6/17/2021
"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 

Read more
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