ACRP CCRC EXAM PREP BUNDLED
2026 TEST BANK REVIEW
COMPLETE QUESTIONS SOLUTIONS
A+
◉ Adverse Event (AE). Answer: any undesirable experience associated
with the use of a medical product in a patient, does not necessarily have
to have a causal relationship with IP
◉ Adverse Drug Reaction (ADR). Answer: All noxious and unintended
responses to a medicinal product related to any dose, causal relationship
◉ Unexpected ADR. Answer: an adverse event that is not consistent
with Investigator's Brochure
◉ Serious Adverse Event. Answer: Any event that:
(1) results in death;
(2) is life-threatening;
(3) results in inpatient hospitalization or prolongation of existing
hospitalization;
(4) results in a persistent or significant disability/incapacity
(5) results in a congenital anomaly/birth defect; or
(6) based upon appropriate medical judgment, may jeopardize the
subject's health and may require medical or surgical intervention to
prevent one of the other outcomes listed above.
, ◉ Reporting guidelines for Fatal or Life-Threatening ADRS. Answer: 7
Calendar Days after first knowledge
◉ Reporting guidelines for serious, unexpected ADRs (not fatal or life-
threatening). Answer: 15 Calendar days after first knowledge
◉ ICH E8. Answer: General Considerations for Clinical Trials
◉ E8 General Principals. Answer: Results of non-clinical investigations
or previous human studies should be sufficient to indicate that the drug
is acceptably safe for proposed investigation in humans, emerging
animal toxicological and clinical data should be reviewed and evaluated
throughout drug development, investigator and sponsor share
responsibility for protection of subjects
◉ Phase 1 Clinical Trial. Answer: A clinical trial where the drug is
tested on a small group of healthy volunteers to test for safety and side
effects. For Oncology Drugs, they are NOT healthy volunteers, 3-20
participants
◉ Phase 2 Clinical Trial. Answer: 50-2000 participants, helps establish
dose and schedule/efficacy
◉ Phase 3 Clinical Trial. Answer: -Only conducted after there is some
preliminary evidence that suggests efficacy
-Controlled AND uncontrolled
2026 TEST BANK REVIEW
COMPLETE QUESTIONS SOLUTIONS
A+
◉ Adverse Event (AE). Answer: any undesirable experience associated
with the use of a medical product in a patient, does not necessarily have
to have a causal relationship with IP
◉ Adverse Drug Reaction (ADR). Answer: All noxious and unintended
responses to a medicinal product related to any dose, causal relationship
◉ Unexpected ADR. Answer: an adverse event that is not consistent
with Investigator's Brochure
◉ Serious Adverse Event. Answer: Any event that:
(1) results in death;
(2) is life-threatening;
(3) results in inpatient hospitalization or prolongation of existing
hospitalization;
(4) results in a persistent or significant disability/incapacity
(5) results in a congenital anomaly/birth defect; or
(6) based upon appropriate medical judgment, may jeopardize the
subject's health and may require medical or surgical intervention to
prevent one of the other outcomes listed above.
, ◉ Reporting guidelines for Fatal or Life-Threatening ADRS. Answer: 7
Calendar Days after first knowledge
◉ Reporting guidelines for serious, unexpected ADRs (not fatal or life-
threatening). Answer: 15 Calendar days after first knowledge
◉ ICH E8. Answer: General Considerations for Clinical Trials
◉ E8 General Principals. Answer: Results of non-clinical investigations
or previous human studies should be sufficient to indicate that the drug
is acceptably safe for proposed investigation in humans, emerging
animal toxicological and clinical data should be reviewed and evaluated
throughout drug development, investigator and sponsor share
responsibility for protection of subjects
◉ Phase 1 Clinical Trial. Answer: A clinical trial where the drug is
tested on a small group of healthy volunteers to test for safety and side
effects. For Oncology Drugs, they are NOT healthy volunteers, 3-20
participants
◉ Phase 2 Clinical Trial. Answer: 50-2000 participants, helps establish
dose and schedule/efficacy
◉ Phase 3 Clinical Trial. Answer: -Only conducted after there is some
preliminary evidence that suggests efficacy
-Controlled AND uncontrolled
