ACRP Exam
What individual serves as the primary liaison between the sponsor and the investigator? -
ANSmonitor
Who is responsible for verifying that the investigator follows the approved protocol and all
approved amendments? - ANSmonitor
Who must be notified if a trial is suspended or terminated prematurely? - ANSthe sponsor
should promptly inform the investigator/institutions and the regulatory authorities of the
termination or suspension and the reasons for the termination or suspension
Who must the monitor inform of CRF entry errors, omissions, or illegibly? - ANSinvestigator
factoral design - ANSUsed for the specific purpose of examining interaction of A and B; 2 or
more treatments are evaluated simultaneously through the use of varying combinations of
the treatments
1. A alone
2. B alone
3. both A & B (useful in determining joint effects of A & B)
4. neither A or B
*another important use of the design is to establish the dose-response characteristics of the
simultaneous use of treatments C & D
What are the purposes of multi center trials? - ANS1. an accepted way of evaluating a new
medication more efficiently; may present as the only practical means of accruing sufficient
subjects to satisfy the trial objective within a reasonable time-frame
2. to provide a better bias for the subsequent generalization of its findings
phase I (human pharmacology) - ANSSAFETY; starts with the initial administration of an
investigational new drug into humans; small # of study subjects 20-80
aspects of phase 1 trials
- to determine the tolerability of the dose range expected to be needed for later clinical
studies and to determine the nature of adverse reactions that can be expected
- characterization of a drug's absorption, distribution, metabolism, and excretion continues
throughout the development plan
-pharmacodynamic studies and studies relating drug blood levels to response (PK/PD
studies) may be conducted healthy volunteer subjects or in patients with the target disease
phase II (therapeutic exploratory) - ANSEFFICACY; the primary objective is to explore
therapeutic efficacy in patients; studies are typically conducted in a group of patients who
, are selected by relatively narrow criteria, leading to a relatively homogenous population and
are closely monitored; early studies often utilize dose escalation designs; several 100
subjects
goal
- determine the dose(s) and regimen for phase III trials
- include evaluation of potential study endpoints, therapeutic regimens, and target
populations
- determine short term side effects and risks associated with the drug
phase III (therapeutic confirmatory) - ANSLONG-TERM SAFETY/SURVIVAL; primary
objective is to demonstrate, or confirm therapeutic benefit; designed to confirm the
preliminary evidence accumulated in phase II that a drug is safe and effective for use in the
intended indication and recipient population; they complete the information needed to
support adequate instructions for use of the drug (official product information); several 100 -
1000's of subjects
studies may further explore the dose-response relationship, or explore the drug's use in
wider populations, in different stages of disease, or in combination with another drug
*end of phase III is when NDA is sent to the FDA for approval
phase IV (therapeutic use) - ANSPOST MARKET; begins after drug approval; are all studies
(other than routine surveillance) performed after drug approval and related to the approved
indication; address FDA requirements for additional information not in NDA
commonly conducted studies include additional drug-drug interaction, dose-response or
safety studies, and studies designed to support use under the approved indication, e.g.
mortality/morbidity studies, epidemiological studies
adverse event - ANSany untoward medical occurrence in a patient or clinical investigation
subject administered a pharmaceutical product and which does not necessarily have to have
a causal relationship with this treatment
e.g. abnormal laboratory finding, symptom, or disease
adverse drug reaction - ANSall noxious and unintended responses to a medicinal product
related to any dose
phrase "responses to a medicinal products," means that a causal relationship between a
medicinal product and an adverse event is at least a reasonable possibility
unexpected adverse drug reaction - ANSan adverse reaction, the nature or severity of which
is not consistent with the applicable product information (e.g. IB for an unapproved
investigational medicinal product)
- expedited reporting is required for additional occurrences of the reaction
What individual serves as the primary liaison between the sponsor and the investigator? -
ANSmonitor
Who is responsible for verifying that the investigator follows the approved protocol and all
approved amendments? - ANSmonitor
Who must be notified if a trial is suspended or terminated prematurely? - ANSthe sponsor
should promptly inform the investigator/institutions and the regulatory authorities of the
termination or suspension and the reasons for the termination or suspension
Who must the monitor inform of CRF entry errors, omissions, or illegibly? - ANSinvestigator
factoral design - ANSUsed for the specific purpose of examining interaction of A and B; 2 or
more treatments are evaluated simultaneously through the use of varying combinations of
the treatments
1. A alone
2. B alone
3. both A & B (useful in determining joint effects of A & B)
4. neither A or B
*another important use of the design is to establish the dose-response characteristics of the
simultaneous use of treatments C & D
What are the purposes of multi center trials? - ANS1. an accepted way of evaluating a new
medication more efficiently; may present as the only practical means of accruing sufficient
subjects to satisfy the trial objective within a reasonable time-frame
2. to provide a better bias for the subsequent generalization of its findings
phase I (human pharmacology) - ANSSAFETY; starts with the initial administration of an
investigational new drug into humans; small # of study subjects 20-80
aspects of phase 1 trials
- to determine the tolerability of the dose range expected to be needed for later clinical
studies and to determine the nature of adverse reactions that can be expected
- characterization of a drug's absorption, distribution, metabolism, and excretion continues
throughout the development plan
-pharmacodynamic studies and studies relating drug blood levels to response (PK/PD
studies) may be conducted healthy volunteer subjects or in patients with the target disease
phase II (therapeutic exploratory) - ANSEFFICACY; the primary objective is to explore
therapeutic efficacy in patients; studies are typically conducted in a group of patients who
, are selected by relatively narrow criteria, leading to a relatively homogenous population and
are closely monitored; early studies often utilize dose escalation designs; several 100
subjects
goal
- determine the dose(s) and regimen for phase III trials
- include evaluation of potential study endpoints, therapeutic regimens, and target
populations
- determine short term side effects and risks associated with the drug
phase III (therapeutic confirmatory) - ANSLONG-TERM SAFETY/SURVIVAL; primary
objective is to demonstrate, or confirm therapeutic benefit; designed to confirm the
preliminary evidence accumulated in phase II that a drug is safe and effective for use in the
intended indication and recipient population; they complete the information needed to
support adequate instructions for use of the drug (official product information); several 100 -
1000's of subjects
studies may further explore the dose-response relationship, or explore the drug's use in
wider populations, in different stages of disease, or in combination with another drug
*end of phase III is when NDA is sent to the FDA for approval
phase IV (therapeutic use) - ANSPOST MARKET; begins after drug approval; are all studies
(other than routine surveillance) performed after drug approval and related to the approved
indication; address FDA requirements for additional information not in NDA
commonly conducted studies include additional drug-drug interaction, dose-response or
safety studies, and studies designed to support use under the approved indication, e.g.
mortality/morbidity studies, epidemiological studies
adverse event - ANSany untoward medical occurrence in a patient or clinical investigation
subject administered a pharmaceutical product and which does not necessarily have to have
a causal relationship with this treatment
e.g. abnormal laboratory finding, symptom, or disease
adverse drug reaction - ANSall noxious and unintended responses to a medicinal product
related to any dose
phrase "responses to a medicinal products," means that a causal relationship between a
medicinal product and an adverse event is at least a reasonable possibility
unexpected adverse drug reaction - ANSan adverse reaction, the nature or severity of which
is not consistent with the applicable product information (e.g. IB for an unapproved
investigational medicinal product)
- expedited reporting is required for additional occurrences of the reaction
