GCP Good Clinical Practice 101 Quiz
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- 1.Name the 3 Geographical Regions involved in ICH?
- 2.
- 3.Who is responsible for creating the TMF (Trial Master File)?
- 4.What are some key elements included in the Investigators Brochure?
- 5.
- A.
data accuracy
- B.
protection of trial subjects
- C.
Process adherence
- D.
Statistical quality checks
- 6.Which document created in 1964 forms the basis of ethical considerations in clinical research?
- A.
Declaration of Geneva
- B.
Declaration of Helsinki
- C.
Declaration of Belfast
- 7.What does ICH stand for?
- A.
International Convention on Homogenization
- B.
International Conference on Harmonisation
- C.
International Conference on Homogenization
- D.
International Convention on Harmonisation
- 8.
- A.
Persuade
- B.
Force
- C.
Coerce or unduly influence
- D.
Use inappropriate methods to influence
- 9.Ccording to ICH GCP the investigator "should be qualified by....."?
- A.
Training and experience
- B.
Education, training and experience
- C.
Education and experience
- D.
Education and training
- 10.According to ICH GCP where would you expect to find a section entitled "Summary of Data and Guidance for the Investigator"
- A.
Protocol
- B.
Clinical Study Report
- C.
Investigator Brochure
- D.
Investigator Agreement
- 11.The form 1572 "Statement of Investigator" is required by:
- A.
IRB
- B.
FDA
- C.
Sponsor
- D.
Investigator
- 12.Prior to subject’s participation in the trial, the _________________should be signed and personally dates by the subject or by the subject’s LAR.
- A.
Protocol
- B.
Clinical Trial Agreement
- C.
IRB Approval Report
- D.
Written Informed Consent Form
- 13.Sponsor responsibilities include
- A.
Design study
- B.
Manage study
- C.
Finance study
- D.
Audit study
- E.
All the above
- 14.
- A.
Amendment
- B.
Site Evaluation
- C.
Audit
- D.
Inspection
- 15.What does IRB Stand for?
- A.
Investigational Review Board
- B.
International Review Board
- C.
Institutional Review Board
- 16.The person responsible for the conduct of the clinical trial at a trial site.
- A.
Clinical Research Coordinator
- B.
Monitor
- C.
Investigator
- D.
Sponsor
- 17.An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.
- A.
LAR (legaly acceptable representive)
- B.
Subject
- C.
Trial Monitor
- D.
Investigator
- 18.
- A.
Results in death
- B.
Is life-threatening
- C.
Requires inpatient hospitalization or prolongation of existing hospitalization
- D.
Results in persistent or significant disability/incapacity
- E.
All the above
- 19.A clinical trial must have IRB/IEC approval before it can begin?
- A.
True
- B.
False
- 20.
- A.
6
- B.
7
- C.
5
- D.
8
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