PharmaAudit Services
Site, TMF and Database Audit
Inspection Preparation
CRO Evaluation
SOP Development
GCP Testing & Training
GCP Training
GCP Knowledge Testing
Free GCP Games
Case Studies
Mock Inspection
TMF Audit
Administration
Home Page
Contact Us
GCP Tests

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.

Test: ICH GCP

Question Number 1:
I - What does the I stand for in the acronym IMP?
A
Investigator
B
Investigative
C
Investigational
D
Interventional

Question Number 2:
C - What C is missing from this statement: The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of XXXX or undue influence on trial subjects.
A
Compensation
B
Cooperation
C
Compulsion
D
Coercion

Question Number 3:
H - What H is missing: The investigator should not implement any deviation from or changes of the protocol without agreement by the sponsor except where necessary to eliminate an immediate XXXX to trial subjects.
A
Harmful effect
B
Hazard
C
Hospitalisation
D
Harmful Adverse Event

Question Number 4:
G - Which G is the topic covered by Annex 13 most closely related to?
A
GCP
B
GDP
C
GLP
D
GMP

Question Number 5:
C - What is missing from section 5.8 of ICH GCP: When trial subjects receive XXXX, the method and manner of XXXX should comply with applicable regulatory requirements.
A
Concomitant Therapy
B
Commercially Available Medication
C
Compensation
D
Correspondence

Question Number 6:
P - What P is missing from this statement: If the trial is blinded, the investigator should promptly document and explain to the sponsor any XXXX unblinding.
A
Premature
B
Previous
C
Preventable
D
Planned

 

(c) PharmaAudit 2009
All rights reserved
PharmaAudit
Home Page
Contact Us