3.4.21 ICH guidelines, ACRP Key Terms
for CCRC exam, CCRC Exam, ACRP
CCRC EXAM PREP, CCRC Exam Prep,
ACRP CCRC, *CCRC Study Set
Quality - answerQ1 to Q6
Efficacy - answerE1 to E12 , wherein GCP E6
Safety - answerS1 to S7 and M3
Multidisciplinary - answerM1, M2, M4
Clinical Safety - answerE1 to E2E
E1 - answerThe extent of population EXPOSURE to assess clinical safety
E2A - answerClinical safety data management : definition and standards for expedited
reporting
E2B - answerMaintenance of clinical safety data management
E2C - answerClinical safety data management: Periodic safety update reports for
marketed drugs
E2CA - answerAddendum to E2C
E2D - answerPost approval safety data management
E2E - answerPharmacovigilance planning
E3 - answerClinical study reports
E4 - answerDose response
E5 - answerEthnic factors in the acceptability of foreign clinical data
E6 - answerGCP!!!
E7-E11 - answerclinical trials
,E7 - answerstudies in support of special populations: geriatrics
E8 - answerGeneral considerations for clinical trials
E9 - answerStat principles
E10 - answerChoice of control group and related issues in clinical trials
E11 - answerClinical investigation of medicinal products in peds population
E12A - answerPrinciples for clinical evaluation of new antihypertensives
Carcinogenicity - answerS1A- S1Cr
Genotoxicity - answerS2A- S2B
Toxicokinetics and Pharmacokinetics - answerS3A- S3B
Toxicity Testing - answerS4-S4A
Reproductive testing - answerS5A- S5B( M)
Biotech products - answerS6
Pharmacology studies - answerS7-S7b
Human Pharmacology Study - answer-Assess Tolerance
-Define/Describe pharmacokinetics and pharmacodynamics
-explore drug metabolism and drug interactions
-estimate activity
Human Pharmacology Study - answerExamples:
-dose tolerance studies
-single and multiple does pharmacokinetics and pharmacodynamic studies
-drug interaction studies
Therapeutic Exploratory Study - answer-explore use for the targeted indication
-estimate dosage for subsequent studies
-provide basis for confirmatory study design, endpoints, methodologies
Therapeutic Exploratory Study - answerExamples:
-earliest trials of relatively short duration in well-defined narrow pt. populations, using
surrogate or phamalogical endpoints
-does-response exploration studies
,Therapeutic Confirmatory Study - answer-demonstrate/confirm efficacy (the ability to
produce a desired or intended result).
-establish safety profile
-provide an adequate basis for assessing the benefit/risk
relationship to support licensing
-establish dose-response relationship
Therapeutic Confirmatory Study - answerExamples:
-adequate and well controlled studies to establish efficacy
-randomized parallel dose-response studies
-clinical safety studies
- studies of mortality/morbidity outcomes
-large simple trials
-comparative studies
Therapeutic Use Study - answer-refine understanding of benefit/risk relationship in
general or special populations/environments
-identify less common adverse reactions
-refine dosing recommedation
Therapeutic Use Study - answerExamples:
-comparative effectiveness studies
-studies of mortality/morbidity outcomes
-studies of additional endpoints
-large simple trials
-pharmacoeconomic studies
Phase I Study - answer-most typical kind study-human pharm.
-usually have non-therapeutic objectives and may be conducted in healthy volunteer
subjects or certain types of pts.
involve one or more of: estimation of initial safety and tolerability, pharmacokinetics,
assessment of pharmacodynamics, and early meausrment of drug activity
Pharmacokinetics Study - answer-PI
-assess the clearance of the drug and to anticipate possible accumulation of parent
drug or metabolites and potential drug-drug interactions
Assessment of pharmacodynamics Study - answer-PI
-may be conducted in healthy volunteer subjects or pt's with the target disease
-can provide early estimates of activity and potential efficacy and may guide dosage and
does regiment in later studies
Phase II Study - answer-most typical kind of study in therapeutic exploratory
-start with the initiation of studies in which the primary objective is to explore therapeutic
efficacy in pt's
-pt's selected by narrow criteria
, -Goal: determine does and regimen for PIII trials
- Doses are usually less than the highest dose used in PI studies
Phase III Study - answer-most typical kind of study-therapeutic confirmatory study
-confirm preliminary evidence accumulated in PII that a drug is safe and effective for
use in intended indication and recipient population
-provide an adequate basis for marketing approval
Phase IV Study - answer-all studies performed after drug approval and related to the
approval indication
-optimizing the drug's use
Study Endpoint - answerResponse variables that are chosen to assess drug effects
Blinding - answer-Reducing or minimizing the risk of biased study outcomes
- intended to limit the occurrence of conscious and unconscious bias
-a procedure where one or more parties to the trial are kept unaware of the treatment
assignments
Single Blind Study - answer-Trial where the treatment assignment is not known by the
study participant
- The investigator and staff are aware of the treatment but the subject is not, or vice-
versa
Double Blind Study - answer-When the study participant and the investigator and
sponsor staff are unaware of the treatment assignments
-Neither the subject nor any of the investigator or sponsor staff who are involved in the
treatment of the subject's are aware of the treatments received
Bias - answerThe systematic tendency of any factors associated with the design,
conduct, analysis, and interpretation of the results of clinical trials to make the estimate
of a treatment effect deviate from its true value
Confirmatory Trial - answer-an adequately controlled trial in which the hypothesis are
stated in advance and evaluated
-necessary to provide firm evidence of safety
-results should be robust
Exploratory Trial - answer-earlier clinical work
-objectives may not always lead to simple tests of pre-defined hypothesis
-may require a more flexible approach to design
Primary Variable - answer-the variable capable of providing the most clinically relevant
and convincing evidence directly related to the objective
-should only be one
for CCRC exam, CCRC Exam, ACRP
CCRC EXAM PREP, CCRC Exam Prep,
ACRP CCRC, *CCRC Study Set
Quality - answerQ1 to Q6
Efficacy - answerE1 to E12 , wherein GCP E6
Safety - answerS1 to S7 and M3
Multidisciplinary - answerM1, M2, M4
Clinical Safety - answerE1 to E2E
E1 - answerThe extent of population EXPOSURE to assess clinical safety
E2A - answerClinical safety data management : definition and standards for expedited
reporting
E2B - answerMaintenance of clinical safety data management
E2C - answerClinical safety data management: Periodic safety update reports for
marketed drugs
E2CA - answerAddendum to E2C
E2D - answerPost approval safety data management
E2E - answerPharmacovigilance planning
E3 - answerClinical study reports
E4 - answerDose response
E5 - answerEthnic factors in the acceptability of foreign clinical data
E6 - answerGCP!!!
E7-E11 - answerclinical trials
,E7 - answerstudies in support of special populations: geriatrics
E8 - answerGeneral considerations for clinical trials
E9 - answerStat principles
E10 - answerChoice of control group and related issues in clinical trials
E11 - answerClinical investigation of medicinal products in peds population
E12A - answerPrinciples for clinical evaluation of new antihypertensives
Carcinogenicity - answerS1A- S1Cr
Genotoxicity - answerS2A- S2B
Toxicokinetics and Pharmacokinetics - answerS3A- S3B
Toxicity Testing - answerS4-S4A
Reproductive testing - answerS5A- S5B( M)
Biotech products - answerS6
Pharmacology studies - answerS7-S7b
Human Pharmacology Study - answer-Assess Tolerance
-Define/Describe pharmacokinetics and pharmacodynamics
-explore drug metabolism and drug interactions
-estimate activity
Human Pharmacology Study - answerExamples:
-dose tolerance studies
-single and multiple does pharmacokinetics and pharmacodynamic studies
-drug interaction studies
Therapeutic Exploratory Study - answer-explore use for the targeted indication
-estimate dosage for subsequent studies
-provide basis for confirmatory study design, endpoints, methodologies
Therapeutic Exploratory Study - answerExamples:
-earliest trials of relatively short duration in well-defined narrow pt. populations, using
surrogate or phamalogical endpoints
-does-response exploration studies
,Therapeutic Confirmatory Study - answer-demonstrate/confirm efficacy (the ability to
produce a desired or intended result).
-establish safety profile
-provide an adequate basis for assessing the benefit/risk
relationship to support licensing
-establish dose-response relationship
Therapeutic Confirmatory Study - answerExamples:
-adequate and well controlled studies to establish efficacy
-randomized parallel dose-response studies
-clinical safety studies
- studies of mortality/morbidity outcomes
-large simple trials
-comparative studies
Therapeutic Use Study - answer-refine understanding of benefit/risk relationship in
general or special populations/environments
-identify less common adverse reactions
-refine dosing recommedation
Therapeutic Use Study - answerExamples:
-comparative effectiveness studies
-studies of mortality/morbidity outcomes
-studies of additional endpoints
-large simple trials
-pharmacoeconomic studies
Phase I Study - answer-most typical kind study-human pharm.
-usually have non-therapeutic objectives and may be conducted in healthy volunteer
subjects or certain types of pts.
involve one or more of: estimation of initial safety and tolerability, pharmacokinetics,
assessment of pharmacodynamics, and early meausrment of drug activity
Pharmacokinetics Study - answer-PI
-assess the clearance of the drug and to anticipate possible accumulation of parent
drug or metabolites and potential drug-drug interactions
Assessment of pharmacodynamics Study - answer-PI
-may be conducted in healthy volunteer subjects or pt's with the target disease
-can provide early estimates of activity and potential efficacy and may guide dosage and
does regiment in later studies
Phase II Study - answer-most typical kind of study in therapeutic exploratory
-start with the initiation of studies in which the primary objective is to explore therapeutic
efficacy in pt's
-pt's selected by narrow criteria
, -Goal: determine does and regimen for PIII trials
- Doses are usually less than the highest dose used in PI studies
Phase III Study - answer-most typical kind of study-therapeutic confirmatory study
-confirm preliminary evidence accumulated in PII that a drug is safe and effective for
use in intended indication and recipient population
-provide an adequate basis for marketing approval
Phase IV Study - answer-all studies performed after drug approval and related to the
approval indication
-optimizing the drug's use
Study Endpoint - answerResponse variables that are chosen to assess drug effects
Blinding - answer-Reducing or minimizing the risk of biased study outcomes
- intended to limit the occurrence of conscious and unconscious bias
-a procedure where one or more parties to the trial are kept unaware of the treatment
assignments
Single Blind Study - answer-Trial where the treatment assignment is not known by the
study participant
- The investigator and staff are aware of the treatment but the subject is not, or vice-
versa
Double Blind Study - answer-When the study participant and the investigator and
sponsor staff are unaware of the treatment assignments
-Neither the subject nor any of the investigator or sponsor staff who are involved in the
treatment of the subject's are aware of the treatments received
Bias - answerThe systematic tendency of any factors associated with the design,
conduct, analysis, and interpretation of the results of clinical trials to make the estimate
of a treatment effect deviate from its true value
Confirmatory Trial - answer-an adequately controlled trial in which the hypothesis are
stated in advance and evaluated
-necessary to provide firm evidence of safety
-results should be robust
Exploratory Trial - answer-earlier clinical work
-objectives may not always lead to simple tests of pre-defined hypothesis
-may require a more flexible approach to design
Primary Variable - answer-the variable capable of providing the most clinically relevant
and convincing evidence directly related to the objective
-should only be one
