1. COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI)
GOOD CLINICAL PRACTICE (GCP) - CANADA CURRICULUM COMPLETION REPORT
Printed on 09/14/2014
LEARNER Syed Abidi (ID: 4388615)
DEPARTMENT Clinical Research
EMAIL abidis@mcmaster.ca
INSTITUTION McMaster University
EXPIRATION DATE
GOOD CLINICAL PRACTICE (GCP) - STUDENT/TRAINEE
COURSE/STAGE: Stage 1/1
PASSED ON: 09/14/2014
REFERENCE ID: 14030511
REQUIRED MODULES
DATE
COMPLETED
SCORE
Overview of New Drug Development 09/14/14 5/5 (100%)
International Conference on Harmonisation (ICH): GCP Requirements 09/14/14 4/5 (80%)
Health Canada and U.S. FDA Regulated Research 09/14/14
9/10
(90%)
Conducting Investigator-Initiated Studies According to Health Canada and FDA Regulations and Good Clinical
Practices
09/14/14 4/5 (80%)
Investigator Obligations in Health Canada and FDA-Regulated Clinical Research 09/14/14
9/10
(90%)
Investigator's Responsibilities and GCP 09/14/14 4/5 (80%)
Managing Investigational Agents According to GCP Requirements 09/14/14
6/10
(60%)
Informed Consent 09/14/14 5/5 (100%)
Detection and Evaluation of Adverse Events 09/14/14 4/5 (80%)
Reporting Serious Adverse Events 09/14/14
8/10
(80%)
Monitoring of Clinical Trials by Industry Sponsors 09/14/14
8/10
(80%)
Audits and Inspections in Clinical Trials 09/14/14
9/10
(90%)
For this Completion Report to be valid, the learner listed above must be affiliated with a CITI Program participating institution or be a paid
Independent Learner. Falsified information and unauthorized use of the CITI Program course site is unethical, and may be considered
research misconduct by your institution.
Paul Braunschweiger Ph.D.
Professor, University of Miami
Director Office of Research Education
CITI Program Course Coordinator