Protocol Deviation Audit Trails
Protocol Deviation Audit Trails is a systematic record within clinical research documentation that captures the chronological sequence, rationale, and resolution of departures from an approved study protocol, thereby providing traceability and accountability for deviations in regulatory compliance and data integrity.
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2017–2026
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Recent Changes in Quality in Japanese Clinical Trials
Kazuyuki Saito, Yasuo Kodama, Shunsuke Ono et al. · Annals of Pharmacotherapy · 2003 · 13 citations
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Ministry of Health Labour and Welfare
Tokyo, Japan
1 h-index
1 publications
13 citations

Kanazawa University
Kanazawa, Japan
1 h-index
1 publications
13 citations
Jichi Medical University
Shimotsuke, Japan
1 h-index
1 publications
13 citations
National Institute of Health Sciences
Tokyo, Japan
1 h-index
1 publications
13 citations
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1 publications · 13 citations
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