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Definitions
ICH E6 Good clinical practice (R2)
A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
References
Audit is systematic and independent examination or review of clinical trial data, records, procedures, and documentation. It is conducted to verify compliance with regulatory requirements, protocol adherence, and data accuracy. Audits are critical in ensuring the integrity and quality of clinical research and may be carried out by regulatory authorities, sponsors, or independent auditing entities. An Audit certificate is issued by auditor upon completion of audit related activities.
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Text inside Group
Simple summary – is first block at any definition page with executive summary.
With patterns, you can save customized blocks to reuse across your site. If you’re repeatedly adding the same groups of blocks to new pages, patterns will save you a lot of time. In this guide, you will learn how to create and use patterns.