MCA MCA-F-501MCA-F-501/12, version 2 – 24 January 2025
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
MCA-F-501/12, version 2 – 24 January 2025 is the official MCA identifier for “Observational Phase IV Clinical Study Application Form”. MCA-F-501/12, version 2 – 24 January 2025 is the official identifier MCA uses for this instrument.
- Instrument
- MCA-F-501
- Full name
- MCA-F-501/12, version 2 – 24 January 2025
- 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.
Observational Phase IV Clinical Study Application Form
Complete three-page observational Phase IV clinical study application, version 2 dated 24 January 2025. It expressly includes medical devices within the related-product choices and records responsible persons, locations, products, patients and study duration. Medicine-specific fields are retained as conditional source context and are not converted into requirements for all device studies. Later revisions and current applicability remain unverified.
MCA-F-501/12, version 2 – 24 January 2025 is the official identifier MCA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.