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 - Section 5 The Sponsor

Question Number 1:
Section 5.2.1 of ICH GCP: The Sponsor: A sponsor may transfer any or all of the trial related duties to a CRO but what always resides with the sponsor?
A
 responsibility for ensuring guidelines and guidelines are complied with
B
 responsibility for ensuring the SOPs are followed
C
 responsibility for the quality and integrity of the trial data
D
 responsibility for the protection of privacy of subject data

Question Number 2:
ICH GCP Section 5.2: Any trial related duties and functions not specifically transferred to and assumed by a CRO are what?
A
 to be documented to clearly state the responsibility
B
 to be defined in a contract between CRO and Sponsor
C
 transferred to the CRO
D
 retained by the sponsor

Question Number 3:
Section 5.7 of ICH GCP: Prior to initiating a trial the sponsor should do what?
A
 define, establish and allocate all trial related duties and functions
B
 document the roles and responsibilites of the sponsor, CRO and other functions
C
 ensure that each person involved in the trial has received adequate training
D
 ensure that all relevant documents are defined and filed

Question Number 4:
Section 5.18 of ICH GCP: Which of the following is not specified as a responsibility of a monitor?
A
 reporting the subject recruitment rate
B
 determining whether all adverse events are appropriately reported
C
 acting as a main line of communication between sponsor and investigator
D
 acting as a main line of communication between the investigator and the IRB/IEC

Question Number 5:
In section 5.23 of ICH GCP which of the following is not listed as something that the sponsor should ensure in multicentre trials?
A
 All investigators conduct the trial in strict compliance with the protocol
B
 The CRFs are designed to capture the required data at all multicentre trial sites
C
 All investigators are kept informed of trial status including the expected date of close of recruitment.
D
 Communication between investigators is facilitated

 
(c) PharmaAudit 2009
All rights reserved
PharmaAudit
Home Page
Contact Us
Related Companies
PharmaSchool Training
PharmaXM Online Testing
Services
Routine Audits
Inspection Preparation