ICH E6(R2) Good Clinical Practice Exam | Verified Exam Questions and
Answers | Latest Updated Study Material 2026
Question:
ICH E6(R2) Good Clinical Practice Exam | Comprehensive
- 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
Answer:
What are the minimum requirements for IRB?
Question:
3 years
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).
Question:
Protocol and amendments
ICF
Advertisements for subjects recruitment
Investigator's brochure
Evidence of investigator's qualifications.
Answer:
Name all five required
documents for IRB review.
Question:
D. When a Serious, Unexpected Adverse Drug Reaction (SADRs) occurs
Answer:
In which of the following instances is it necessary to contact the IRB/IEC?
, Question:
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
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.
Question:
2 years, 2 years.
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.
Question:
Immediately
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.
Question:
C. Investigator
Answer:
According to ICH who is responsible for signing
off a completed Case Report Form (CRF)?
Answers | Latest Updated Study Material 2026
Question:
ICH E6(R2) Good Clinical Practice Exam | Comprehensive
- 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
Answer:
What are the minimum requirements for IRB?
Question:
3 years
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).
Question:
Protocol and amendments
ICF
Advertisements for subjects recruitment
Investigator's brochure
Evidence of investigator's qualifications.
Answer:
Name all five required
documents for IRB review.
Question:
D. When a Serious, Unexpected Adverse Drug Reaction (SADRs) occurs
Answer:
In which of the following instances is it necessary to contact the IRB/IEC?
, Question:
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
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.
Question:
2 years, 2 years.
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.
Question:
Immediately
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.
Question:
C. Investigator
Answer:
According to ICH who is responsible for signing
off a completed Case Report Form (CRF)?
