1|Page
CCRC EXAM NEWEST 2025 ACTUAL EXAM TEST
BANK| COMPLETE 350 REAL EXAM QUESTIONS AND
CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) GRADED A+| CCRC EXAM PREP|| NEW!!
New safety information regarding a study drug should be updated by the
sponsor by:
a. notifying the IRB
b. notifying the investigator
c. updating the protocol
d. updating the Investigator's Brochure - Correct Answer - d
A serious adverse event which as resulted in death requires:
a. an autopsy report
b. a detailed account of relationship to drug
c. a definitive exclusion of the effects of concomitant drugs
d. all of the above - Correct Answer - d
The term non-clinical studies refer to:
a. studies in vitro cell culture models
b. studies in organ culture
c. studies in animal odels
d. pilot human studies - Correct Answer - c
pg. 1
,2|Page
Characterization of drug's absorption, metabolism, and excretion:
a. are confined to phase I studies
b. can be conducted in phase II studies if phase I studies are inconclusive
c. are never studied in phase III studies
d. continue throughout the development plan - Correct Answer - d
Trials of short duration in narrow patient populations using
pharmacological endpoints or clinical measures are likely to be:
a. phase I
b. phase II
c. phase III
d. phase IV - Correct Answer - b
Studies which provide the most information for risk benefit relationship
of a drug are likely to be:
a. phase I
b. phase II
c. phase III
d. phase IV - Correct Answer - c
Epidemiologic and pharmacoeconomic studies are likely to be:
a.. phase I
b. phase II
c. phase III
pg. 2
,3|Page
d. phase IV - Correct Answer - d
Formulations of the drug should be characterized on:
a. maximum tolerated dose
b. bioavailability
c. half-life
d. drug clearance - Correct Answer - b
A control group may consist of all of the following except:
a. a group of distinct age composition
b. a placebo
c. active control
d. different doses of the drug - Correct Answer - a
According to the ICH, the sponsor may request the following from the
IRB:
a. a copy of the minutes of an IRB meeting
b. IRB correspondence with OHRP
c. rationale for IRB disapproval
d. written procedures and membership lists - Correct Answer - d
With regard to keeping the IRB informed about the IB, ICH states that:
a. it is the sponsor's responsibility
pg. 3
, 4|Page
b. it is the investigator's responsibility
c. it is not needed
d. updates to the brochure need not be provided - Correct Answer - b
According to ICH, the ultimate responsibility for the quality and
integrity of the data rests with:
a. the investigator
b. the research coordinator
c. the site monitor and CRO
d. the sponsor - Correct Answer - d
Under ICH, the sponsor's responsibilities for electronic data handling
includes all of the following except:
a. accuracy, reliability and consistent performance guided by SOPs
b. security and backup of the system and access to authorized
individuals only
c. safeguarding of the blinding
d. part 11 compliance - Correct Answer - d
In a double blind trial, the person who should be unaware of the
treatment should not be involved in assessing:
a. eligibility
b. endpoints
c. compliance
pg. 4
CCRC EXAM NEWEST 2025 ACTUAL EXAM TEST
BANK| COMPLETE 350 REAL EXAM QUESTIONS AND
CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) GRADED A+| CCRC EXAM PREP|| NEW!!
New safety information regarding a study drug should be updated by the
sponsor by:
a. notifying the IRB
b. notifying the investigator
c. updating the protocol
d. updating the Investigator's Brochure - Correct Answer - d
A serious adverse event which as resulted in death requires:
a. an autopsy report
b. a detailed account of relationship to drug
c. a definitive exclusion of the effects of concomitant drugs
d. all of the above - Correct Answer - d
The term non-clinical studies refer to:
a. studies in vitro cell culture models
b. studies in organ culture
c. studies in animal odels
d. pilot human studies - Correct Answer - c
pg. 1
,2|Page
Characterization of drug's absorption, metabolism, and excretion:
a. are confined to phase I studies
b. can be conducted in phase II studies if phase I studies are inconclusive
c. are never studied in phase III studies
d. continue throughout the development plan - Correct Answer - d
Trials of short duration in narrow patient populations using
pharmacological endpoints or clinical measures are likely to be:
a. phase I
b. phase II
c. phase III
d. phase IV - Correct Answer - b
Studies which provide the most information for risk benefit relationship
of a drug are likely to be:
a. phase I
b. phase II
c. phase III
d. phase IV - Correct Answer - c
Epidemiologic and pharmacoeconomic studies are likely to be:
a.. phase I
b. phase II
c. phase III
pg. 2
,3|Page
d. phase IV - Correct Answer - d
Formulations of the drug should be characterized on:
a. maximum tolerated dose
b. bioavailability
c. half-life
d. drug clearance - Correct Answer - b
A control group may consist of all of the following except:
a. a group of distinct age composition
b. a placebo
c. active control
d. different doses of the drug - Correct Answer - a
According to the ICH, the sponsor may request the following from the
IRB:
a. a copy of the minutes of an IRB meeting
b. IRB correspondence with OHRP
c. rationale for IRB disapproval
d. written procedures and membership lists - Correct Answer - d
With regard to keeping the IRB informed about the IB, ICH states that:
a. it is the sponsor's responsibility
pg. 3
, 4|Page
b. it is the investigator's responsibility
c. it is not needed
d. updates to the brochure need not be provided - Correct Answer - b
According to ICH, the ultimate responsibility for the quality and
integrity of the data rests with:
a. the investigator
b. the research coordinator
c. the site monitor and CRO
d. the sponsor - Correct Answer - d
Under ICH, the sponsor's responsibilities for electronic data handling
includes all of the following except:
a. accuracy, reliability and consistent performance guided by SOPs
b. security and backup of the system and access to authorized
individuals only
c. safeguarding of the blinding
d. part 11 compliance - Correct Answer - d
In a double blind trial, the person who should be unaware of the
treatment should not be involved in assessing:
a. eligibility
b. endpoints
c. compliance
pg. 4
