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ACRP CCRP EXAM Study Guide.
Transformation of Variables - Answer✔the replacement of a variable by a function of that
variable: for example, replacing a variable x by the square root of x or the logarithm of x. In a
stronger sense, a transformation is a replacement that changes the shape of a distribution or
relationship.
Parallel Design - Answer✔Subjects are randomized to 2 or more tx groups simultaneously
Crossover Design - Answer✔Subjects are randomized to a sequence of treatments (like Abbott)
example: treatment A, then treatment B
Pre-Post Design - Answer✔participants are measured on the dependent variable before and after
an intervention
Factorial Design - Answer✔Two or more treatments are evaluated simultaneously (varying
combinations of treatments) to study interaction effects
Type I Error - Answer✔mistaken rejection of the null hypothesis
Type II Error - Answer✔failing to reject a false null hypothesis
Covariate - Answer✔Independent variable that can affect the outcome of a trial, but is not of
direct interest. Ex: age, gender
Blind Review - Answer✔occurs between trial completion and breaking of the blind
Double-Dummy - Answer✔used to compare drugs with very different appearance (for example,
different dosage forms). For this purpose, subjects take two types of drug, one of which is a
placebo.
Life-Threatening - Answer✔subject was at risk of death at time of the event
Reporting Timeline: Fatal or Life-Threatening Unexpected SAEs - Answer✔No later than 7 days
Reporting Timeline: Serious ADRs - Answer✔ASAP, but no later than 15 days
Special Populations of ICH8 - Answer✔Pregnant women, nursing women, children
Demand Characteristics (Hawthorne Effect) - Answer✔when participants act differently simply
because they know that they are in an experiment
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ACRP CCRP EXAM Study Guide.
Transformation of Variables - Answer✔the replacement of a variable by a function of that
variable: for example, replacing a variable x by the square root of x or the logarithm of x. In a
stronger sense, a transformation is a replacement that changes the shape of a distribution or
relationship.
Parallel Design - Answer✔Subjects are randomized to 2 or more tx groups simultaneously
Crossover Design - Answer✔Subjects are randomized to a sequence of treatments (like Abbott)
example: treatment A, then treatment B
Pre-Post Design - Answer✔participants are measured on the dependent variable before and after
an intervention
Factorial Design - Answer✔Two or more treatments are evaluated simultaneously (varying
combinations of treatments) to study interaction effects
Type I Error - Answer✔mistaken rejection of the null hypothesis
Type II Error - Answer✔failing to reject a false null hypothesis
Covariate - Answer✔Independent variable that can affect the outcome of a trial, but is not of
direct interest. Ex: age, gender
Blind Review - Answer✔occurs between trial completion and breaking of the blind
Double-Dummy - Answer✔used to compare drugs with very different appearance (for example,
different dosage forms). For this purpose, subjects take two types of drug, one of which is a
placebo.
Life-Threatening - Answer✔subject was at risk of death at time of the event
Reporting Timeline: Fatal or Life-Threatening Unexpected SAEs - Answer✔No later than 7 days
Reporting Timeline: Serious ADRs - Answer✔ASAP, but no later than 15 days
Special Populations of ICH8 - Answer✔Pregnant women, nursing women, children
Demand Characteristics (Hawthorne Effect) - Answer✔when participants act differently simply
because they know that they are in an experiment
1|Page
