Back | Close this Window

Your answers to each question are listed below. Your correct answers are in green
text and your incorrect answers are in red text. Please note that some questions
may not be graded. Those will appear in black text.

Question 1: What is the purpose of Directive 2001/20/EC?

Rationale: The correct answer is "b) To harmonise processes across Europe ensuring
protection of humans"
Your Answer: To protect humans in clinical trials ensuring global harmonization
process

Question 2: What are the differences between ICH GCP and the requirements of the
Directive
Rationale: The correct answer is "b) Adoption of the Directive into local law"
Your Answer: Definition of non-interventional trials, qualified person and witness
is given in ICH GCP

Question 3: Can informed Consent be taken from vulnerable subjects according to EU

CTD (Clinical trial Directive)?
Rationale: The correct answer is "b) Only if the vulnerable subject has the
opportunity to ask questions and informed accordingly"
Your Answer: Only if the vulnerable subject has the opportunity to ask questions
and informed accordingly

Question 4: What are the responsibilities of the site when dealing with vulnerable
subjects?
Rationale: The correct answer is "c) Demonstrate experience in dealing with
vulnerable subjects"
Your Answer: Investigator can overrule the vulnerable subject for his or her own
good

Question 5: What is the role of the EudraCT database?

Rationale: The correct answer is "b) Exchange of clinical trial information between
EU member states (MB)"
Your Answer: Exchange of clinical trial information between EU member states (MB)

Question 6: Which of the following is NOT the responsibility of the sponsor in view
of Serious Adverse Event (SAE) reporting?
Rationale: The correct answer is "d) Collect SAEs only once a year"
Your Answer: Ongoing safety evaluation of investigational Product (IP)

Question 7: What is the responsibility of the Principal Investigator (PI) in view

of Serious Adverse Event (SAE) reporting?
Rationale: The correct answer is "d) All of the above"
Your Answer: All of the above

Question 8: Which of the following is NOT part of the EU GCP Directive (2005/28/EC,
08 Apr 2005)?
Rationale: The correct answer is "d) Financial disclosure"
Your Answer: Definitions