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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: Clinical Trials Update 2009

Question Number 1:
What was the subject of the new EU guideline published in Chapter IV of Eudralex Vol 10 in June 2009?
A
 Advanced Therapy Medicinal Products
B
 GMP for Investigational Medicinal Products
C
 Co-ordination of GCP Inspections across the EU
D
 Reporting of Serious Breaches

Question Number 2:
What is the subject of the initiative launched by EMEA and FDA in July 2009
A
 Standardisation of Ethics Committees
B
 Collaboration on GCP Inspections
C
 Reporting of Adverse Events
D
 Joint Marketing Authorisations

Question Number 3:
What initiative was launched as a pilot by the EMEA Clinical Trials Facilitation Group in early 2009?
A
 Voluntary Harmonisation Procedure
B
 Reporting of Serious Breaches
C
 International sharing of Adverse Event data
D
 Paediatric Investigation Plans

Question Number 4:
According to the EU's revised Question and Answer document in Eudralex Vol 10 can clinical trial safety reports be aligned with PSURs?
A
 No
B
 Yes but only if previous PSURs have been submitted
C
 Yes but only if no PSURs have previously been submitted
D
 Yes but only if it shortens the reporting timeline and does not lengthen it

Question Number 5:
Which organisation has set up a database in 2009 for registration of clinical trials in India?
A
 Indian National Institute of Medical Statistics
B
 FDA
C
 World Health Organisation
D
 Institute of Clinical Research India

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