Form 11-01
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
Form 11-01 is the official NHSRC identifier for “Application for Continuing Review”. Form 11-01 is the official identifier NHSRC uses for this instrument.
- Instrument
- Form
- Full name
- Form 11-01
- 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.
Application for Continuing Review
Complete NHSRC continuing-review form: policy statement, sections A–H, funding/site/study-status fields, explicit Device choice, all progress/safety questions, amendment/revision questions, five numbered investigator assurances and the full enclosure/office-decision checklist. All 30 original empty checkboxes are retained. The investigator must obtain prior NHSRC approval for protocol/consent changes; no fixed amendment-review period is stated. Original NRCM/NCST names, repeated DSMB-report request, fee wording and NO EXTENSIONS CAN BE GRANTED remain as printed. The continuation requirement is not presented as a universal approval duration. This exact original is linked from the current PHIM protocol-forms page under a 2025 upload path. The upload path is not an issuance or effective date. Rendered Office page images preserve source layout and are labelled as renders. Currentness, later versions, fees and present applicability remain under review; excluded from default current-law discovery.
Form 11-01 is the official identifier NHSRC uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.