ICH E6(R2) GOOD CLINICAL PRACTICE
QUESTIONS WITH CORRECT DETAILED
ANSWERS|| LATEST UPDATED
1. - At least 5 members What are the minimum requirements for IRB?
- At least one member
whose primary area of
interest is in a nonsci-
entific area
-At least one member
who is independent of
the institution/trial site
2. 3 years The IRB/IEC should retain all relevant records (e.g. written procedures,
membership lists, lists of occupations/aflliations 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).
3. Protocol and amend-
ments
5. Impartial Witness
ICF
Advertisements for
subjects recruitment
Investigator's brochure
Evidence of investiga-
tor's qualifications.
4. D. When a Serious, Un-
expected Adverse Drug
Reaction (SADRs) oc-
curs
, ICH E6(R2) GOOD CLINICAL PRACTICE
QUESTIONS WITH CORRECT DETAILED
ANSWERS|| LATEST UPDATED
Name all five required documents for IRB
review.
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
QUESTIONS WITH CORRECT DETAILED
ANSWERS|| LATEST UPDATED
1. - At least 5 members What are the minimum requirements for IRB?
- At least one member
whose primary area of
interest is in a nonsci-
entific area
-At least one member
who is independent of
the institution/trial site
2. 3 years The IRB/IEC should retain all relevant records (e.g. written procedures,
membership lists, lists of occupations/aflliations 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).
3. Protocol and amend-
ments
5. Impartial Witness
ICF
Advertisements for
subjects recruitment
Investigator's brochure
Evidence of investiga-
tor's qualifications.
4. D. When a Serious, Un-
expected Adverse Drug
Reaction (SADRs) oc-
curs
, ICH E6(R2) GOOD CLINICAL PRACTICE
QUESTIONS WITH CORRECT DETAILED
ANSWERS|| LATEST UPDATED
Name all five required documents for IRB
review.
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
