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: GCP Inspections

Question Number 1:
In the EU who is responsible for conducting GCP inspections?
A
 The sponsor
B
 The EMEA
C
 Member States' Competent Authorities
D
 Ethics Committees

Question Number 2:
What is the number of the form issued by FDA following an Inspection?
A
 1572
B
 483
C
 1573
D
 482

Question Number 3:
Which of the following is most true concerning exchange of GCP inspection reports in the EU?
A
 They must be kept within the member state where the inspection took place
B
 They can be distributed freely to all competent authorities within the EU
C
 A competent authority can request a copy of an inspection report for any reason.
D
 Exchange of inspection reports is restricted and is only allowed under certain circumstances

Question Number 4:
Which of the following is most true concerning FDA inspection of foreign clinical trials not conducted under an IND?
A
 FDA must be allowed to inspect these trials if the data are to be used in a submission to FDA and they wish to inspect
B
 FDA will expect local regulators to inspect these trials on their behalf
C
 FDA cannot inspect these trials
D
 There is nothing in FDA regulatory requirements regarding inspection of these trials

Question Number 5:
What is a Reporting Inspector?
A
 An EU inspector which can be appointed if more than one member state is involved in the inspection.
B
 An FDA representative who observes and inspection but does not participate
C
 An inspector from a Sponsor Company
D
 The inspector who writes the inspection report.

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