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 ResearchEMAIL abidis@mcmaster.caINSTITUTION McMaster UniversityEXPIRATION DATE

GOOD CLINICAL PRACTICE (GCP) - STUDENT/TRAINEE

COURSE/STAGE: Stage 1/1PASSED ON: 09/14/2014REFERENCE ID: 14030511

REQUIRED MODULES DATECOMPLETED 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 ClinicalPractices 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 paidIndependent Learner. Falsified information and unauthorized use of the CITI Program course site is unethical, and may be consideredresearch misconduct by your institution.

Paul Braunschweiger Ph.D.Professor, University of MiamiDirector Office of Research EducationCITI Program Course Coordinator