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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.
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eCF Focus Session: Audit Trail Review in Practice
The eClinical Forum published a joint paper with SCDM in April 2021, titled “Audit Trail Review: Key Tool to Ensure Data Integrity”. (If you missed it, you can download it here: Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0 (eclinicalforum.org) ) Now that members have had time to review the paper and perhaps discuss with colleagues, we thought it is a good time to hear what different members are doing, or are planning to do, regarding audit trail review. This focus session will not be discussing the paper, but rather will be discussing what practices around audit trail review our members are taking.
This is a two-hour focus session. The first hour will be presentations of case-studies from eClinical Forum members. The second hour will be a round-table discussion.
eSRA was used in a Japanese research paper on data quality of medical information systems
Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."