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ABMed EC-FO-

EC-FO- 0003

Déclaration des événements indésirables graves — formulaire CIOMS
BeninAgence béninoise du Médicament et des autres produits de SantéClinical TrialsCurrentness under review
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Document status

Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

What this code is

EC-FO- 0003 is the official ABMed identifier for “Déclaration des événements indésirables graves — formulaire CIOMS”. EC-FO- 0003 is the official identifier ABMed uses for this instrument.

Instrument
EC-FO-
Full name
EC-FO- 0003
Category
Clinical Trials
Source links
Source publication
French
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About this regulation

Déclaration des événements indésirables graves — formulaire CIOMS

CIOMS suspected-adverse-reaction reporting form included as Annex 5 of ABMed’s clinical-trial package. Captures the patient, reaction, suspected and concomitant medicines, and manufacturer report. The form retains medicine-specific fields; its use for device or IVD trial events requires confirmation against the applicable trial requirements.

EC-FO- 0003 is the official identifier ABMed uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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