ACRP CCRA/CCRC Certification Exam prep
questions and answers
Pharmacodynamics definition - ANSWER>>What the drug does to the
body. Biochemical and physiological effects of a drug on the body.
Pharmacokinetics definition - ANSWER>>The activity of the drug in the
body over time. The process by which drugs are absorbed, distributed,
localized in tissues, and excreted.
Phase 1 testing goal - ANSWER>>Determine safe dose range in which a
drug or biological can be administered, the method of absorption and
distribution in the body, and possible toxicity
Phase 0 testing goal - ANSWER>>Exploratory study to determine
pharmacodynamics and pharmacokinetics of a drug using a small, short
term dosage in healthy adults
Phase 2 testing goal - ANSWER>>Evaluate preliminary safety and efficacy
in the target population with the specified disease or condition. Also
includes determination of min/max dose and PK data
Phase 3 testing goal - ANSWER>>Fully assess safety, efficacy, and drug
dosage in a large group of subjects with the specific disease to be treated
Adverse event definition - ANSWER>>Any untoward medical occurrence in
a patient or clinical investigation subject administered a pharmaceutical
product and which does not necessarily have a causal relationship with this
treatment
, Adverse drug reaction definition - ANSWER>>Pre-approval clinical
experience: All noxious and unintended responses to a medicinal product
related to any dose should be considered adverse drug reactions
Marketed medicinal products: A response to a drug which is noxious and
unintended and which occurs at doses normally used in man for
prophylaxis, diagnosis, or therapy of disease or for modification of
physiological function
Unexpected adverse drug reaction definition - ANSWER>>An adverse
reaction, the nature or severity of which is not consistent with the applicable
product information (e.g. investigator's brochure)
AEs: serious vs severe - ANSWER>>Serious is based on the outcome of
the event usually associated with events that pose a threat to patient's life
or functioning
Severity is the intensity of a specific event but the event itself may be of
minor medical significance (e.g. severe headache)
Serious adverse event definition - ANSWER>>Any untoward medical
occurrence that at any dose results in death, is life-threatening, requires
inpatient hospitalization, results in persistent or significant disability, or is a
congenital anomaly/birth defect
Unexpected adverse reaction definition - ANSWER>>AE where the nature
or severity is not consistent with information in relevant source documents.
For trials, Investigators brochure acts as source doc.
An event more specific or more severe than described in IB is considered
unexpected.
Fatal or life-threatening unexpected adverse drug reaction reporting
timeline - ANSWER>>As soon as possible but no later than 7 days after
questions and answers
Pharmacodynamics definition - ANSWER>>What the drug does to the
body. Biochemical and physiological effects of a drug on the body.
Pharmacokinetics definition - ANSWER>>The activity of the drug in the
body over time. The process by which drugs are absorbed, distributed,
localized in tissues, and excreted.
Phase 1 testing goal - ANSWER>>Determine safe dose range in which a
drug or biological can be administered, the method of absorption and
distribution in the body, and possible toxicity
Phase 0 testing goal - ANSWER>>Exploratory study to determine
pharmacodynamics and pharmacokinetics of a drug using a small, short
term dosage in healthy adults
Phase 2 testing goal - ANSWER>>Evaluate preliminary safety and efficacy
in the target population with the specified disease or condition. Also
includes determination of min/max dose and PK data
Phase 3 testing goal - ANSWER>>Fully assess safety, efficacy, and drug
dosage in a large group of subjects with the specific disease to be treated
Adverse event definition - ANSWER>>Any untoward medical occurrence in
a patient or clinical investigation subject administered a pharmaceutical
product and which does not necessarily have a causal relationship with this
treatment
, Adverse drug reaction definition - ANSWER>>Pre-approval clinical
experience: All noxious and unintended responses to a medicinal product
related to any dose should be considered adverse drug reactions
Marketed medicinal products: A response to a drug which is noxious and
unintended and which occurs at doses normally used in man for
prophylaxis, diagnosis, or therapy of disease or for modification of
physiological function
Unexpected adverse drug reaction definition - ANSWER>>An adverse
reaction, the nature or severity of which is not consistent with the applicable
product information (e.g. investigator's brochure)
AEs: serious vs severe - ANSWER>>Serious is based on the outcome of
the event usually associated with events that pose a threat to patient's life
or functioning
Severity is the intensity of a specific event but the event itself may be of
minor medical significance (e.g. severe headache)
Serious adverse event definition - ANSWER>>Any untoward medical
occurrence that at any dose results in death, is life-threatening, requires
inpatient hospitalization, results in persistent or significant disability, or is a
congenital anomaly/birth defect
Unexpected adverse reaction definition - ANSWER>>AE where the nature
or severity is not consistent with information in relevant source documents.
For trials, Investigators brochure acts as source doc.
An event more specific or more severe than described in IB is considered
unexpected.
Fatal or life-threatening unexpected adverse drug reaction reporting
timeline - ANSWER>>As soon as possible but no later than 7 days after
