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: Principles of ICH GCP

Question Number 1:
According to ICH GCP Section 2: The Principles of GCP which of the following is not one of the 13 stated priniciples?
A
 Freely given informed consent should be obtained from every subject prior to clinical trial participation.
B
 The standard treatment of trial subjects should not be inhibited by inclusion in a clinical trial
C
 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
D
 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

Question Number 2:
According to ICH GCP Section 2: The Principles of GCP which of the following is not one of the 13 stated priniciples?
A
 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
B
 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
C
 The minimum amount of data required to answer the scientific question of the clinical trial should be collected from trial subjects.
D
 Systems with procedures that assure the quality of every aspect of the trial should be implemented.

Question Number 3:
According to ICH GCP Section 2: The Principles of GCP which of the following is not one of the 13 stated priniciples?
A
 A clinical trial should be conducted using the smallest number of trial subjects considered adequate to provide a robust and accurate answer to the trial objectives.
B
 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
C
 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
D
 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

Question Number 4:
When do the Principles of ICH GCP state that foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society?
A
 After a protocol has been approved
B
 Before a protocol is designed
C
 Before a trial is initiated
D
 Before the first subject is enrolled

Question Number 5:
In Section 2 of ICH GCP entitled the Priniciples of ICH GCP is GMP referred to?
A
 No
B
 Indirectly i.e. refers to handling of investigational product but not specifically GMP
C
 Almost i.e refers to manufacturing, handling and storage but does not state GMP
D
 Yes GMP is specifically referenced

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