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The eClinical Forum Download area contains publically available surveys, presentations, articles and reports that can inform your decision making, challenge your thinking, and identify new technological and regulatory trends related to eClinical trials.

 

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

 

Requirements for Electronic Data for Regulated Clinical Trials V2018PR

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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.  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 and if systems and process that manage these data have the necessary features.

This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over several years to be able to produce such a comprehensive list of compliance requirements for evaluating electronic systems that will manage data used in regulated clinical research against regulations and guidances from FDA, EMA, PMDA and ICH.  This work is a result of the vast experience of the REG members who come from a variety of different eCF Member companies. They have spent hours debating each regulation or guidance and how to word the eCF Requirements to correctly meet the needs in the regulatory document.  If any one company were to undertake such a project, the hours spent would justify an eClinical Forum membership very quickly.

Release of 2018 eCF Requirements Document for Public Use -- The V2018PR document (mapped to 14 regulatory documents) is being release to the public as we believe that it will be of significant use to all.   

The eCF Requirements V2018PR can be downloaded via the download button below.

At this time, the 2019 Version (mapped to an additional 7 documents) is reserved for eClinical Forum members only.  For information on becoming an eClinical Forum member (and thus having access to the eCF Requirements V2019), please see membership details via the membership tab on this website.

The eCF REG absolutely welcomes feedback. Please send feedback to REG@eclinicalforum.org



File size 1078 K
Downloads 107
Date Fri 03/29/2019 @ 05:38
Author Suzanne Bishop
EMail suzanne.bishop@eclinicalforum.org

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White Paper: Electronic Data Capture in Clinical Trials using Service Providers

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Untitled 2 The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers (e.g. EMA Reflection Paper and ICH GCP Addendum). The eCF has engaged with regulators (including the EMA GCP IWG and FDA) and industry stakeholders in developing the documents.

The White Paper focuses on web/cloud based EDC utilizing service providers and the delivery of hosting or application management services in a manner that prevents exclusive sponsor control over site entered data.  The concept of an investigator “zone of control” is described to assist the ongoing governance of data by respective sites.  Such control is facilitated via continuous investigator access to data; use of independent third parties (the i3P); an appropriate documentation framework and task delegation/control. The eCF proposal is not mutually exclusive of other methods of meeting regulatory expectations.

The document is part of a 3 document set comprising:

  1. White Paper: Electronic Data Capture in Clinical Trials using Service Providers
  2. Checklist for Electronic Data Capture Systems in Clinical Trials using Service Providers
  3. Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers


File size 1218 K
Downloads 266
Date Thu 12/22/2016 @ 02:01
Author Webmaster1
EMail info@eclinicalforum.org

RATING:   COMMENTS (0)  DOWNLOAD
Checklist for Electronic Data Capture Systems in Clinical Trials using Service Providers

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Untitled 2 The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers (e.g. EMA Reflection Paper and ICH GCP Addendum). The eCF has engaged with regulators (including the EMA GCP IWG and FDA) and industry stakeholders in developing the documents.

The White Paper focuses on web/cloud based EDC utilizing service providers and the delivery of hosting or application management services in a manner that prevents exclusive sponsor control over site entered data.  The concept of an investigator “zone of control” is described to assist the ongoing governance of data by respective sites.  Such control is facilitated via continuous investigator access to data; use of independent third parties (the i3P); an appropriate documentation framework and task delegation/control. The eCF proposal is not mutually exclusive of other methods of meeting regulatory expectations.

The document is part of a 3 document set comprising:

  1. White Paper: Electronic Data Capture in Clinical Trials using Service Providers
  2. Checklist for Electronic Data Capture Systems in Clinical Trials using Service Providers
  3. Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers


File size 733 K
Downloads 218
Date Thu 12/22/2016 @ 02:01
Author Webmaster1
EMail info@eclinicalforum.org

RATING:   COMMENTS (0)  DOWNLOAD
Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

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Untitled 2

The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers (e.g. EMA Reflection Paper and ICH GCP Addendum). The eCF has engaged with regulators (including the EMA GCP IWG and FDA) and industry stakeholders in developing the documents.

 

The White Paper focuses on web/cloud based EDC utilizing service providers and the delivery of hosting or application management services in a manner that prevents exclusive sponsor control over site entered data.  The concept of an investigator “zone of control” is described to assist the ongoing governance of data by respective sites.  Such control is facilitated via continuous investigator access to data; use of independent third parties (the i3P); an appropriate documentation framework and task delegation/control. The eCF proposal is not mutually exclusive of other methods of meeting regulatory expectations.

The document is part of a 3 document set comprising:

  1. White Paper: Electronic Data Capture in Clinical Trials using Service Providers
  2. Checklist for Electronic Data Capture Systems in Clinical Trials using Service Providers
  3. Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers


File size 737 K
Downloads 122
Date Thu 12/22/2016 @ 02:00
Author Webmaster1
EMail info@eclinicalforum.org

RATING:   COMMENTS (0)  DOWNLOAD
Is your electronic health record system suitable for originating records that will be used in regulated clinical trials?

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Nearly 200 attendees participated in a webinar delivered by the eClinical Forum for ACRP.

The objective of the webinar was to allow attendees to:

  • Recognize the need to assess their electronic healthcare system to determine its appropriateness for originating and/or housing data that could be used in a regulated clinical research trial
  • Access a free tool to assist in assessing electronic health record systems

The presentation covered:

  • The rationale for assessing EHR / EMR Systems
  • The need for a standard mechanism to assess GCP compliance while minimizing burden for busy sites
  • The background to eSRA: Investigator Site System eSource-Readiness Assessment
  • How to access and use eSRA for free


File size 1659 K
Downloads 152
Date Wed 03/02/2016 @ 05:19
Author ECF Webmaster
EMail

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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.

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