ICH GCP E6 (R2)

Question 1

Blinding/Masking

Answer 1

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and doubleblinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

Question 2

Which following document is a document associated with study start-up?
A. INVESTIGATOR’S BROCHURE
B. MASTER RANDOMIZATION LIST
C. MONITORING VISIT REPORTS
D. AUDIT CERTIFICATE

Answer 2

A

Question 3

Which following document is a document associated with study start-up?
A. INVESTIGATIONAL PRODUCT(S)
ACCOUNTABILITY AT SITE
B. SOURCE DOCUMENTS
C. SIGNED PROTOCOL AND AMENDMENTS, IF
ANY, AND SAMPLE CASE REPORT FORM
D. MONITORING VISIT REPORTS

Answer 3

C

Question 4

Which forms are required during study start up from both sponsor and investigator?
A. MASTER RANDOMIZATION LIST
B. ADVERTISEMENT FOR SUBJECT
RECRUITMENT
C. CERTIFICATE(S) OF ANALYSIS OF
INVESTIGATIONAL PRODUCT(S) SHIPPED
D. TRIAL INITIATION MONITORING REPORT

Answer 4

D.
A. MASTER RANDOMIZATION LIST: Sponsor
B. ADVERTISEMENT FOR SUBJECT
RECRUITMENT: Investigator
C. CERTIFICATE(S) OF ANALYSIS OF
INVESTIGATIONAL PRODUCT(S) SHIPPED: Sponsor