MCA MCA-GL-503,MCA-GL-503, Version 1
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
MCA-GL-503, Version 1 is the official MCA identifier for “Guideline for GCP Inspections of Clinical Trials”. MCA-GL-503, Version 1 is the official identifier MCA uses for this instrument.
- Instrument
- MCA-GL-503,
- Full name
- MCA-GL-503, Version 1
- Category
- Clinical Trials
- Source publication
- English
- Readable HTML
- 1 language version
- Published
- —
- Effective
- —
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Guideline for GCP Inspections of Clinical Trials
Complete ten-page guideline dated 26 June 2025, covering clinical-trial inspection types, inspectees, preparation, conduct, finding grades, reports, corrective actions and closure. It is retained as a common inspection dependency for device and diagnostic clinical trials, with the original medicine-specific statutory wording and external references preserved. Its inspection, notice, reporting and response periods apply in that clinical context. The printed coming-into-effect date is 27 June 2025; later changes and current applicability remain unverified.
MCA-GL-503, Version 1 is the official identifier MCA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.