1|Page
CCRC EXAM LATEST 2026-2027 ACTUAL EXAM WITH COMPLETE
QUESTIONS AND CORRECT DETAILED ANSWERS (100% VERIFIED
ANSWERS) |ALREADY GRADED A+| ||PROFESSOR VERIFIED||
||BRANDNEW!!!||
ICH recommends that responsibility for the investigational product
and its accountability be assigned to
a) The sub-investigator
b) The research coordinator
c) The study monitor
d) The pharmacist - ANSWER-d) The pharmacist
Drug accountability for the investigational product includes
a) Delivery and inventory at the trial site
b) Use and return of the product
c) Batch ,serial numbers and expiration dates
d) All of the above - ANSWER-d) All of the above
a) Delivery and inventory at the trial site
b) Use and return of the product
c) Batch ,serial numbers and expiration dates
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With regard to randomization the investigator should:
a) Follow the sponsor's randomization plan
b) Explain to the sponsor any premature unblinding due to an
adverse event
c) Both a and b
d) Neither a nor b - ANSWER-c) Both a and b
a) Follow the sponsor's randomization plan
b) Explain to the sponsor any premature unblinding due to an
adverse event
According to ICH the informed consent should be
a) Signed but not dated by the subject
b) Signed and dated by the subject only
c) Signed and dated by the subject and the person obtaining
consent
d) Witnessed for all consent situations - ANSWER-c) Signed and
dated by the subject and the person obtaining consent
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Features of the informed consent in ICH which differ from DHHS
guidelines include all of the following except
a) The probability of assignments to each treatment group
b) The risks and benefits of alternative treatments
c) The access to the subject's medical records for the monitor,
auditor and IRB
d) The anticipated expenses for the subject
e) The number of subjects in the trial. - ANSWER-e) The number
of subjects in the trial.
The ICH guidelines differ from DHHS guidelines in that they
a) Describe in detail the features of a non-therapeutic trial
b) Describe the process of managing non-therapeutic trials
c) Affirm the need for signed and dated consent and IRB approval
of non-therapeutic trials
d) All of the above - ANSWER-d) All of the above
a) Describe in detail the features of a non-therapeutic trial
b) Describe the process of managing non-therapeutic trials
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c) Affirm the need for signed and dated consent and IRB approval
of non-therapeutic trials
1.1 The following agreements between sponsor and investigator
should be documented in writing
a) Financial arrangements and contracts
b) Protocol agreement document
c) Investigator's brochure receipt and confidentiality document
d) All of the above - ANSWER-d) All of the above
a) Financial arrangements and contracts
b) Protocol agreement document
c) Investigator's brochure receipt and confidentiality document
According to ICH the case report forms should be
a) Consistent with source documents
b) Dated, initialed and explained when needed
c) Show the original when corrections are made
d) All of the above - ANSWER-d) All of the above
a) Consistent with source documents
CCRC EXAM LATEST 2026-2027 ACTUAL EXAM WITH COMPLETE
QUESTIONS AND CORRECT DETAILED ANSWERS (100% VERIFIED
ANSWERS) |ALREADY GRADED A+| ||PROFESSOR VERIFIED||
||BRANDNEW!!!||
ICH recommends that responsibility for the investigational product
and its accountability be assigned to
a) The sub-investigator
b) The research coordinator
c) The study monitor
d) The pharmacist - ANSWER-d) The pharmacist
Drug accountability for the investigational product includes
a) Delivery and inventory at the trial site
b) Use and return of the product
c) Batch ,serial numbers and expiration dates
d) All of the above - ANSWER-d) All of the above
a) Delivery and inventory at the trial site
b) Use and return of the product
c) Batch ,serial numbers and expiration dates
,2|Page
With regard to randomization the investigator should:
a) Follow the sponsor's randomization plan
b) Explain to the sponsor any premature unblinding due to an
adverse event
c) Both a and b
d) Neither a nor b - ANSWER-c) Both a and b
a) Follow the sponsor's randomization plan
b) Explain to the sponsor any premature unblinding due to an
adverse event
According to ICH the informed consent should be
a) Signed but not dated by the subject
b) Signed and dated by the subject only
c) Signed and dated by the subject and the person obtaining
consent
d) Witnessed for all consent situations - ANSWER-c) Signed and
dated by the subject and the person obtaining consent
,3|Page
Features of the informed consent in ICH which differ from DHHS
guidelines include all of the following except
a) The probability of assignments to each treatment group
b) The risks and benefits of alternative treatments
c) The access to the subject's medical records for the monitor,
auditor and IRB
d) The anticipated expenses for the subject
e) The number of subjects in the trial. - ANSWER-e) The number
of subjects in the trial.
The ICH guidelines differ from DHHS guidelines in that they
a) Describe in detail the features of a non-therapeutic trial
b) Describe the process of managing non-therapeutic trials
c) Affirm the need for signed and dated consent and IRB approval
of non-therapeutic trials
d) All of the above - ANSWER-d) All of the above
a) Describe in detail the features of a non-therapeutic trial
b) Describe the process of managing non-therapeutic trials
, 4|Page
c) Affirm the need for signed and dated consent and IRB approval
of non-therapeutic trials
1.1 The following agreements between sponsor and investigator
should be documented in writing
a) Financial arrangements and contracts
b) Protocol agreement document
c) Investigator's brochure receipt and confidentiality document
d) All of the above - ANSWER-d) All of the above
a) Financial arrangements and contracts
b) Protocol agreement document
c) Investigator's brochure receipt and confidentiality document
According to ICH the case report forms should be
a) Consistent with source documents
b) Dated, initialed and explained when needed
c) Show the original when corrections are made
d) All of the above - ANSWER-d) All of the above
a) Consistent with source documents
