1. Completion Report https:/'www.citiprograrr.org/rnetnbers/learnersllicrbystage asp'?strK.
CITI Collaborative Institutional Training Initiative
Good Clinical Practice Course for Clinical Trials Involving Drugs Curriculum
Completion Report
Printed on 611112013
Learner: Tigran Uzunyan (username: tuzunyan)
Institution: The Pragma Corporation Armenia Branch
Contact Information Bashinjaghyan 169/1 0,
Yerevan, 0078 Armenra
Department. Pfizer
Phone: +374 91621622
Email: uzunyantigran@gmail com
GCP Course for Clinical Trials Involving Investigational Drugs (internationat
/ ICH focus):
e 1. GCP Passed on 05/30/13 Ref# 10329114
Date l
lective Modules iCompletedl Score
he ClTl Good Clinical Practice Course for Clinical Trials 05t28t13 :2t3 (67%)
Involving Drugs and Biologics
onducting Investigator-lnitiated Studies According to
05t28t13 r3l3 (100%)
DA Regulations and GCP
;
fvestlo_qlor in FDA-Regulated Research _O_O!1qq!io1s i 05129113 (100%)
ttrtanaging lnveiiigaiional Agents According to GCp 05t2et13 i5/5 (100%)
Requirements
Informed Consent in Clinical Trials of Druqs and
05t29t13 4t4 (100%)
Biologics
Monitoring Clinical Trials of Drugs by Industry Sponsors : OSlgOlt 3 ',717 (100%)
Audits and Inspections of Clinical Trials of Drugs and i 05130113 t 415 (80%)
Biologi_cs
),vv,eerryv1rie9eywr oofft Neeyw_ pDrruugg DDDeeevevvloeeplmlooepnptmmeennt t i:i : 05/30/13 6/6 ((100%)
verview of ICH GCP i 05/30/13 i 2tS (40o/o)
ICH-Comparison Between ICH GCP E6 and U S FDA i OSlgOlt3 i4l4 (100%)
Regulations i i
Detecting and Evaluating Adverse Events i oslgolts 4t4 (i00%)
Reporting Serious Adverse Events in Investigations of - i OSl3}l13 i44 (OOr/")
Drugs and Biologics
ompleting the ClTl GCP Course 05/30/13 i no quiz
For this Completion Report to be valid, the learner listed above must be
affiliated with a ClTl participating institution. Falsified information and
unauthorized use of the ClTl course site is unethical, and may be
considered scientific misconduct by your institution.
Paul Braunschweiger Ph D.
Professor, University of Miami
Director Office of Research Education