en-USen-GB

A WEALTH OF eCLINICAL AND eHEALTH KNOWLEDGE

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.

This section will become a comprehensive repository for eClinical Trial-related information, as well as a focal point for companies searching for information on this topic. If you have suggestions or questions about the Knowledge section please contact the eClinical Forum.


You must be a registered user to download content. Registration is FREE! Login or Register

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 This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License

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

Thumbnail
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 80
Date Thu 12/22/2016 @ 02:01
Author Webmaster1
EMail info@eclinicalforum.org

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

Thumbnail
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 53
Date Thu 12/22/2016 @ 02:01
Author Webmaster1
EMail info@eclinicalforum.org

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

Thumbnail
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 44
Date Thu 12/22/2016 @ 02:00
Author Webmaster1
EMail info@eclinicalforum.org

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

Thumbnail

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 53
Date Wed 03/02/2016 @ 05:19
Author ECF Webmaster
EMail

RATING:   COMMENTS (0)  
ACT Article on eCF Risk Based Monitoring Approaches and Best Practices

Thumbnail

The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality. Applied Clinical Trials July/August 2013



File size 3317 K
Downloads 20
Date Tue 12/15/2015 @ 10:31
Author eCF RBM Team
EMail info@eclinicalforum.org

RATING:   COMMENTS (0)  
< BACK  1 of 8  NEXT >

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.

YOU ARE FREE:

  • to Share — to copy, distribute and transmit the work
  • to Remix — to adapt the work

UNDER THE FOLLOWING CONDITIONS: 

  • Attribution — You must attribute the work to the eClinical Forum (but not in any way that suggests that the eClinical Forum endorses you or your use of the work).
  • Non-commercial — You may not use this work for commercial purposes.
  • Share Alike — If you alter, transform, or build upon this work, you may distribute the resulting work only under the same or similar license to this one.      

WITH THE UNDERSTANDING THAT: 

  • Waiver — Any of the above conditions can be waived if you get permission from the eClinical Forum.
  • Public Domain — Where the work or any of its elements is in the public domain under applicable law, that status is in no way affected by the license.
  • Other Rights — In no way are any of the following rights affected by the license: a) Your fair dealing or fair use rights, or other applicable copyright exceptions and limitations; b) The author's moral rights; c) Rights other persons may have either in the work itself or in how the work is used, such as publicity or privacy rights.
  • Notice — For any reuse or distribution, you must make clear to others the license terms of this work.

Only a small portion of the knowledge generated by the eClinical Forum is in the public domain. An extensive archive of information is available to members

Tell me more about membership