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GCP Tests

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.

Test: ICH GCP - What am I?

Question Number 1:

What am I the stated objective of?

"to provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions."

A
ICH Guidelines
B
ICH GCP Guideline
C
ICH E3
D
ICH E9

Question Number 2:

What am I according to ICH GCP?

"Documentation that allows reconstruction of the course of events."

A
Trial Master File
B
Source Documentation
C
Data Clarification Form
D
Audit Trail

Question Number 3:

What am I according to ICH GCP?

"The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled."

A
Audit
B
Monitoring
C
Quality Control
D
Inspection

Question Number 4:

What am I according to ICH GCP?

"A committee that a sponsor may organize to coordinate the conduct of a multicentre trial"

A
Data Monitoring Committee
B
Independent Data Monitoring Committee
C
Coordinating Committee
D
Data and Safety Monitoring Board

Question Number 5:

What am I according to ICH GCP?

"Any public or private entity or agency or medical or dental facility where clinical trials are conducted."

A
Trial Site
B
Investigational Site
C
Institution (medical)
D
Trial Institution

 

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