| 1. Regulatory authorities never require clinical trials for |
new drugs
new surgical procedures
new medical devices
new herbal medicinal products |
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| 2. A surrogate clinical trial outcome is |
always a safety outcome
used more in phase II than in phase III trials
used in virtual clinical trials
used only in explorative trials |
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| 3. Clinical trial randomisation of study subjects is performed to reduce the influence of |
evaluation bias
selection bias
efficacy bias
performance bias
|
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| 4. A meta-analysis is |
the pooling of the results from several studies
the analysis of the data of one large clinical trial
a computer algorithm for estimation of accurate point estimates
samples size calculation for multi-centre trials |
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| 5. The term NDA is an abbreviation used to describe a |
New Device Application
New Diagnostic Application
New Drug Application
New Diuretic Application |
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| 6. A drug Regulatory Authority does not approve |
the names of the members of an Ethic Committee
the trial protocol
the drug import licence
the distribution of a drug |
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| 7. The ICH Guidelines provides detailed guidance about |
GLP, GMP and GCP
GLP and GCP, but not GMP
GMP and GCP , but not GLP
GCP, but not GLP and GMP |
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| 8. The ICH GCP Guideline addresses the responsibilities of the |
Investigator Sponsor and IRB
Patients, Investigator and Sponsor
Sponsor, IRB and Regulatory Authority
Investigator, patients and IRB |
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| 9. At an inspection, the following items are reviewed |
documents, facilities, hospital records
SOP, facilities, patients
publications, documents, correspondence
CVs, publications, correspondence |
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| 10. When was the first version of the Declaration of Helsinki published? |
1947
1964
1978
1996 |
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| 11. The Belmont Report was compiled as a result of |
Human right violations in clinical research in Japan
Human right violations in clinical research in Germany
Human right violations in clinical research in US
Human right violations in clinical research in UK |
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| 12. After completion of a trial the Ethics Committee should retain all their records for at least: |
3 years
5 years
7 years
9 years |
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