Instructions for completing the Clinical Trial Site Information Form

The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a protocol or implementing subsequent amendment(s) at the clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations or the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.

Data and Resources

Additional Info

Field Value
Source
Version
Author
Author Email
Maintainer
Maintainer Email
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French) Instructions pour remplir le formulaire d'information sur le lieu de l'essai clinique
Update Frequency as_needed
Geographic Scope []
Criticality Level []
Sensitivity Level unrestricted
Language
Contact Person
Contact Email
Data Dictionary
Open Canada Date Published 2022-01-18 00:00:00
Open Canada Date Modified
Open Canada Subject ["health_and_safety"]
Open Canada Keywords {"fr": ["formulaire d'information sur le site d'essai clinique", "formulaire CTSI", "instructions pour le remplir", "promoteurs d'essais cliniques"], "en": ["clinical-trial site-information form", "CTSI form", "instructions for completing", "clinical-trial sponsors"]}
Open Canada Collection publication
Principal Organization
Reference Data
Official Source