ICH E6(R2) Good Clinical Practice
Questions with 100% Correct Answers
- At least 5 members
- At least one member whose primary area of interest is in a nonscientific area
-At least one member who is independent of the institution/trial site Correct
Answer: What are the minimum requirements for IRB?
3 years Correct Answer: The IRB/IEC should retain all relevant records (e.g.
written procedures, membership lists, lists of occupations/affiliations of members,
submitted documents, minutes of meetings, and correspondence) for a period
of at least ___ _________ after completion of the trial and make them available
upon request from the regulatory authority(ies).
Protocol and amendments
ICF
Advertisements for subjects recruitment
Investigator's brochure
Evidence of investigator's qualifications. Correct Answer: Name all five required
documents for IRB review.
D. When a Serious, Unexpected Adverse Drug Reaction (SADRs) occurs Correct
Answer: In which of the following instances is it necessary to contact the
IRB/IEC?
, A. Each time a new subject is enrolled
B. If the investigator does not complete enrollment
C. When a subject is found to be noncompliant with the trial medication
D. When a Serious, Unexpected Adverse Drug Reaction (SADRs) occurs
Impartial Witness Correct Answer: If the subject is unable to read or if a legally
acceptable representative is unable to read, an _______________ should be
present during the entire informed consent decision.
2 years, 2 years. Correct Answer: Essential documents should be retained until at
least ___ ________ after the last approval of a marketing application in an ICH
region and until there are no pending or contemplated marketing applications
in an ICH region or at least ___ ________ have elapsed since the formal
discontinuation of clinical development of the investigational product.
Immediately Correct Answer: All serious adverse events (SAEs) should be
reported ____________ to the sponsor except for those SAEs that the protocol or
other document (eg, Investigator's Brochure) identifies as not needing
immediate reporting.
C. Investigator Correct Answer: According to ICH who is responsible for signing
off a completed Case Report Form (CRF)?
A. Study site coordinator
B. Research nurse
C. Investigator
Questions with 100% Correct Answers
- At least 5 members
- At least one member whose primary area of interest is in a nonscientific area
-At least one member who is independent of the institution/trial site Correct
Answer: What are the minimum requirements for IRB?
3 years Correct Answer: The IRB/IEC should retain all relevant records (e.g.
written procedures, membership lists, lists of occupations/affiliations of members,
submitted documents, minutes of meetings, and correspondence) for a period
of at least ___ _________ after completion of the trial and make them available
upon request from the regulatory authority(ies).
Protocol and amendments
ICF
Advertisements for subjects recruitment
Investigator's brochure
Evidence of investigator's qualifications. Correct Answer: Name all five required
documents for IRB review.
D. When a Serious, Unexpected Adverse Drug Reaction (SADRs) occurs Correct
Answer: In which of the following instances is it necessary to contact the
IRB/IEC?
, A. Each time a new subject is enrolled
B. If the investigator does not complete enrollment
C. When a subject is found to be noncompliant with the trial medication
D. When a Serious, Unexpected Adverse Drug Reaction (SADRs) occurs
Impartial Witness Correct Answer: If the subject is unable to read or if a legally
acceptable representative is unable to read, an _______________ should be
present during the entire informed consent decision.
2 years, 2 years. Correct Answer: Essential documents should be retained until at
least ___ ________ after the last approval of a marketing application in an ICH
region and until there are no pending or contemplated marketing applications
in an ICH region or at least ___ ________ have elapsed since the formal
discontinuation of clinical development of the investigational product.
Immediately Correct Answer: All serious adverse events (SAEs) should be
reported ____________ to the sponsor except for those SAEs that the protocol or
other document (eg, Investigator's Brochure) identifies as not needing
immediate reporting.
C. Investigator Correct Answer: According to ICH who is responsible for signing
off a completed Case Report Form (CRF)?
A. Study site coordinator
B. Research nurse
C. Investigator
