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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

Audit Trail Review

  • 29 January 2019
  • Author: Webmaster1
  • Number of views: 3431
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Audit Trail Review

With the increased focus on data integrity from regulators, the routine use of audit trail review as a tool is required.   This team will explore and provide guidance on what is the recommended scope for review, provide definitions, determine ‘what’ data (and in what part of the data lifecycle) should be reviewed with an audit trail vs other data integrity controls and finally recommend ‘how’ an audit trail review should be conducted (frequency, visualizations, exception reports etc). A white paper will be released to eCF members in 1Q 2020 with the anticipation of releasing it to the public by 1Q 2021.

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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry.  This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned.   Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials. 

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eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023"

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, NMPA, MHRA 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 source or manage 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.

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