CRCR130 Crossword

Initiates a clinical trial
Any negative occurrence in the health of a clinical trial subject who is administered a drug
System to collect and analyze information, identify and investigate problems, and take appropriate and effective action to prevent their recurrence
Canadian regulator branch responsible for inspections
Regulates, evaluates and monitors the safety, efficacy, and quality of therapeutic and diagnostic products in Canada
The act by a regulatory authority(ies), of conducting an official review of documents, facilities, records
Investigator related inspection
A deficiency or deviation from Division 5 noted by the inspector
The study includes a sufficient number of patients with the disease or condition being studied
Clinical study lacking a comparator
Pharmacokinetic studies
US equivalent of CTA
International set of standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials
An REB must be this
An Ethics board can be local or _____
Do no harm
To be meaningful and informed consent must be ___
Informed Consent is a ______ of information exchange
Informed consent consists of initial and _____ consent
For informed consent to be valid the subject has to show ___