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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.

 

 

 

 

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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.

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

 

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 261
Date Wed 03/02/2016 @ 05:19
Author ECF Webmaster
EMail

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eSRA: A Project to Self-Evaluate the GCP Compliance of Systems Holding Source Data for Clinical Trials (ACDM UK 10Mar14)

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Investigators are frequently asked to complete sponsor-specific assessments of their EHR systems to enable sponsors to evaluate clinical trial data that will be sourced from these systems. The eClinical Forum has developed a free, standard tool that can help sites to do this quickly, easily, and once for all sponsors.

This presentation provides an overview of the assessment tool and information on access and use.

Key points:

    • Why assess EHR systems
    • Why develop and use a standardized tool
    • The self-assessment tool – process, content, system
    • Feedback
    • Implementation

 

It is important that electronic health record systems (EHRS) that will supply source data for clinical research be designed and maintained to meet regulatory requirements. Sponsors bear the responsibility for ensuring that data sourced from these systems are acceptable. As a result investigators are frequently being asked to complete sponsor-specific assessments of their EHR systems. 

The eClinical Forum, a non-commercial, global organization has developed a free and standard self-assessment tool that can help sites to do this quickly, easily, and once for all sponsors.  With the aid of information provided by their EHR vendor, the site can quickly identify if its system and/or processes are compliant with research regulations or if additional processes need to be put into place.

Using this assessment tool will enable sponsors to evaluate and manage risk. Regulators and sponsors should feel confident in the quality of eSource coming from assessed sites.



File size 403 K
Downloads 146
Date Thu 12/03/2015 @ 09:27
Author eSRA Team
EMail info@eClinicalforum.org

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EHR4CR: An Innovative Platform and Business Model for Re-Use of EHR for Clinical Research (ACDM UK 10Mar14)

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Improved access to patient data is key to managing bottlenecks in clinical research. The presentation gives an overview of one of the largest public-private partnerships aimed at providing adaptable, reusable and scalable solutions for re-using patient level data from Electronic Health Record systems for Clinical Research.The presentation gives an insight into how the EHR4CR platform and services will:

1.    Enable re-use of electronic health records to do better upfront protocol optimization and planning.

Today… A third of protocol amendments are avoidable; over 40% of amendments occur before first patient first dose

2.    Provide tools for sites to identify candidates for clinical trials by electronically searching EHRs in order to improve patient recruitment which is one of the biggest challenges for clinical research.

Today… 50% per cent of clinical trials fail to achieve the target recruitment rate

3.    Connect healthcare and research systems to improve the capture and exchange of clinical trial data.

Today… Over 40% of clinical trial data is entered manually into both healthcare and research systems; Transcription errors increase the workload for monitoring, querying, and responding to queries; Complex processes must be put in place to manage the ‘source’

During 2014 the project will be engaged in activities for externalisation of the platform and services



File size 1527 K
Downloads 63
Date Thu 12/03/2015 @ 09:28
Author eCF EHR4CR Team
EMail info@eclinicalforum.org

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Submission of comments to FDA on Draft eSource Guidance

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The eClinical Forum held an open discussion with members from pharma, CROs, and associated software vendors, to talk about this draft FDA guidance on Jan 8, 2013.  The resulting comments are a consensus of member opinion. They have been submitted to the FDA on March 12, 2013.



File size 335 K
Downloads 86
Date Tue 03/12/2013 @ 03:44
Author eCF
EMail info@eclinicalforum.org

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EHR4CR - A new technological platform enabling the re-use of data from electronic health records

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CASE STUDY EHR4CR - A new technological platform enabling the re-use of data from electronic health records.

  • Optimizing drug development speed and efficiency in Europe .
  • Overcoming barriers such as limited access to EHRs for research and difficulties to perform queries across multiple EHRs.
  • Reducing the redundant clinical trial data entry by connecting healthcare and clinical trial systems for data exchange.


File size 1012 K
Downloads 56
Date Tue 03/12/2013 @ 08:13
Author eCF EHR4CR Team
EMail info@eclinicalforum.org

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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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