CRP 104 Lecture 2 Flashcards
CTA definition
application made by sponsor to Health Canada requesting authroization to conduct a clinical trial in Canada
No Objection Letter
HC approves the CTA
Clarifax
HC request for clarification on the CTA during review
Not satisfactory notice NSN
HC issues when significant deficiencies in the CTA. Ends review of a CTA.
Who approves a CTA
Pharmaceuitical Drugs Directorate PDD, or biologics and radiopharmaceutical drugs directorate BRDD
Screening request
from HC, documents are missing from the CTA
reasons for CTA-A (5)
-affect selection, criteria for selection, monitoring, dismissal of participants
-affect evaluation of clinical efficacy of drug
-alter risk to health of participant
-affect safety evaluation of drug
-extend duration of CT
CTA-A does not require (2)
PSEAT
Investigator’s brochure (unless changed)
changes not requiring CTA-A
email HC with cover letter and docs with tracked changes. HC will not confirm.
product monograph definition
factual, scientific document on the drug product that does not contain promotional masterial. Describes the properties, claims, indications and conditions of use for the drug or safe and optimal use.
three parts of product monograph
-health professional information
-scientific information
-consumer information
