WorksheetsGCP - SET 2
Total questions: 10
Worksheet time: 10mins
1. What is IRB?
A) Investigator Research Board
B) Independent Research Board
C) Institutional Review Board
D) Investigator Review Board
2. What is IEC?
A) Investigator Education Committee
B) Independent Ethics Committee
C) Investigator Ethics Committee
D) Independent Ethics Conference
3. All documents should be obtained by IRB/IEC except:
A) Investigator’s Brochure
B) Informed Consent Forms
C) Subject Identifiers
D) Trial Protocol and Amendment
4. When should IRB/IEC conduct a continuing review of each ongoing trial?
A) Minimum 2 times a year
B) Every month
C) No specific time
D) At least once a year
5. What is the meaning of legally acceptable representative?
A) A person who attends the informed consent process with subject
B) Individual who is independent of the trial who cannot be influenced study team
C) Individual under applicable law to consent on behalf of subject
D) A person who is a relative of the subject
6. Following are the criteria of impartial witness except:
A) Attends the informed consent process
B) One of the study team members
C) Independent of the trial
D) Reads the informed consent form
7. It is recommended that the IRB/IEC should include:
A) Head of every clinical departments
B) At least seven members
C) At least one member in scientific area
D) At least one member who is independent of trial site
8. Following are procedures that IRB/IEC should document in writing except:
A) Scheduling and conducting meetings
B) Providing expedited review of trial protocols
C) Frequency of continuing review
D) Appointment of principal investigators
9. Investigators should promptly report all the following to the IRB/IEC except:
A) Addition of new co-investigators
B) Protocol Deviation
C) New information that affects subjects safety
D) Serious Adverse Event
10. How long should IRB/IEC retain all relevant records after completion of trial?
A) 2 years
B) 3 years
C) 4 years
D) 5 years
