LMC Login | CPMC Login | My Games Account Login
Change Region: Asia | Europe | USA | UK | RoW
Register for Updates & Free Games Account
Complete the form below to register with us for updates. We will update you when new challenges and games are available to play.
First Name:
Surname:
Country:
Email:
Re-enter email:
If you would like a free PharmaSchool Games Account so you can record your weekly GCP Challenge Scores please check the box below and add a password:
Free Games Account:
Password:
Re-enter Password:
 
 
 
Weekly GCP Challenge

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.


Challenge: ICH GCP Test

Question Number 1:
Which of the following is the ICH GCP definition of Essential Documents?
A
 Documents to provide evidence of compliance to the applicable guidelines and local regulatory requirements.
B
 Documents which individually and collectively permit evaluation of the conduct of a study and the quality of data produced.
C
 The minimum documentation required to legally allow subjects to be recruited into a study.
D
 Documents to demonstrate compliance with the protocol, the relevant guidelines and applicable local regulatory requirements.

Question Number 2:

What does ICH GCP define as "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of Clinical Trials"?
A
 SOPs
B
 Quality Management Plan
C
 ICH E Guidelines
D
 Good Clinical Practice

Question Number 3:

The following is the ICH GCP definition of what?

"Detailed, written instructions to achieve uniformity of the performance of a specific function"
A
 Standard Operating Procedures
B
 Good Clinical Practice
C
 Protocol
D
 Audit Plan

Question Number 4:
According to ICH GCP the scientific integrity of the trial and the credibility of the data from the trial depend substantially on what?
A
 The Quality Management Plan
B
 Adherence to SOPs, Guidelines and applicable local regulatory requirements
C
 Trial Design
D
 Protocol

Question Number 5:
According to ICH GCP the extent and nature of what should be determined based on considerations such as objective, purpose, design, complexity, blinding, size and endpoints of the trial?
A
 Auditing
B
 Monitoring
C
 Source Data Verification
D
 Quality Control

Sort the Challenges
GCP & Guidelines
Trial Design
Adverse Events
Monitoring
Statistics
Abbreviations
General
Show All
International Sites: UK Europe Asia USA
PharmaSchool Ltd.
t: +44 (0) 845 224 0891 f: +44 (0) 845 224 0873 e: info@PharmaSchool.org