CCRC EXAM NEWEST 2025 ACTUAL EXAM TEST

• | P a g e

pg. 1

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:

• notifying the IRB
• notifying the investigator
• updating the protocol
• updating the Investigator's Brochure - Correct Answer - d

A serious adverse event which as resulted in death requires:

• an autopsy report
• a detailed account of relationship to drug
• a definitive exclusion of the effects of concomitant drugs
• all of the above - Correct Answer - d

The term non-clinical studies refer to:

• studies in vitro cell culture models
• studies in organ culture
• studies in animal odels
• pilot human studies - Correct Answer - c
• / 4

• | P a g e

pg. 2

Characterization of drug's absorption, metabolism, and excretion:

• are confined to phase I studies
• can be conducted in phase II studies if phase I studies are inconclusive
• are never studied in phase III studies
• 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:

• phase I
• phase II
• phase III
• phase IV - Correct Answer - b

Studies which provide the most information for risk benefit relationship

of a drug are likely to be:

• phase I
• phase II
• phase III
• phase IV - Correct Answer - c

Epidemiologic and pharmacoeconomic studies are likely to be:

a.. phase I

• phase II
• phase III 2 / 4

• | P a g e

pg. 3

• phase IV - Correct Answer - d

Formulations of the drug should be characterized on:

• maximum tolerated dose
• bioavailability
• half-life
• drug clearance - Correct Answer - b

A control group may consist of all of the following except:

• a group of distinct age composition
• a placebo
• active control
• different doses of the drug - Correct Answer - a

According to the ICH, the sponsor may request the following from the

IRB:

• a copy of the minutes of an IRB meeting
• IRB correspondence with OHRP
• rationale for IRB disapproval
• written procedures and membership lists - Correct Answer - d

With regard to keeping the IRB informed about the IB, ICH states that:

• it is the sponsor's responsibility 3 / 4

• | P a g e

pg. 4

• it is the investigator's responsibility
• it is not needed
• 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:

• the investigator
• the research coordinator
• the site monitor and CRO
• the sponsor - Correct Answer - d

Under ICH, the sponsor's responsibilities for electronic data handling

includes all of the following except:

• accuracy, reliability and consistent performance guided by SOPs
• security and backup of the system and access to authorized

individuals only

• safeguarding of the blinding
• 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:

• eligibility
• endpoints
• compliance
• / 4