EC-FO- 0002
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
EC-FO- 0002 is the official ABMed identifier for “Demande d’autorisation d’essai clinique”. EC-FO- 0002 is the official identifier ABMed uses for this instrument.
- Instrument
- EC-FO-
- Full name
- EC-FO- 0002
- Category
- Clinical Trials
- Source publication
- French
- 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.
Demande d’autorisation d’essai clinique
Version 1 application form for new clinical-trial authorisations. Covers the trial, sponsor, investigational product and regulatory information. Device and IVD submissions use this common application with Section III of EC-LD-0001 and the submission checklist.
EC-FO- 0002 is the official identifier ABMed uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.