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Exam(Elaborations)ACRP-CP 2025 Correctly Answered!!
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Exam(Elaborations)ACRP-CP 2025 Correctly Answered!!
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Name: Score:78 Multiple choice questions
Definition 1 of 78
when each subject is randomized to a sequence of two or more treatments and hence acts as
their own control for treatment comparisons
Superiority Study
Crossover
Confirmatory Trial
Dose Response Study
Term 2 of 78
If there is a a serious unexpected adverse drug reaction in a blinded trial, when should the
investigator unblind the subject?
to estimate treatment risks and benefits for a larger population
The manufacturer of the product and/or the regulatory authorities
The investigator unblinds before reporting the SUADR, in order to determine a safe
treatment
the subjects must be reconsented and the irb/iec should be informed and approve the
changes if the trial is to continue
Term 3 of 78
Centralized monitoring supports clinical data review by examining data trends (T/F)
True
False. If a CRC is a qualified physician they can adjust IP dose
to obtain the subject's reason for withdrawal
False
,Term 4 of 78
The investigator is required to share names of subjects with the IRB/IEC (T/F)
True
the subjects must be reconsented and the irb/iec should be informed and approve the
changes if the trial is to continue
False. changes to safety language must be submitted to the IRB
False
Definition 5 of 78
- IP accountability records
- Subject screening log
- Signed ICFs
Dose Response Study
Non-Clinical Study
Contents of the site TMF
The purpose of the SIV is to
Term 6 of 78
Any changes to safety language in an IB should be submitted to the IRB/IEC (T/F)
False
False. If a CRC is a qualified physician they can adjust IP dose
in the Sponsor's files
True
,Definition 7 of 78
- Not conducted on human subjects.
-Provide preliminary safety and pharmacokinetic data needed to support studies in human
Non-Clinical Study
Post Market
IRB/IEC Evaluates
Superiority Study
Definition 8 of 78
-can be prepared for by developing a program for use in children
- experience with use in children so far should be included in the development plan
-conduct pharmacodynamic/pharmacokinetic studies in children if there is no relevant
information available from similar compounds
Therapeutic Trial
Pediatric Trials
Equivalence Study
Confirmatory Trial
Term 9 of 78
Data Vulnerabilities
-clear endpoints
-Appropriate comparators
-Adequate # of subjects
before recruiting the first subject
When the aim of the trial is to assess the patients reaction to varying doses
-Data variations
-Confounders
, Term 10 of 78
Who should send Annual Progress Reports to the IRB/IEC
The Investigator
An event occurring after treatment start that may complicate interpretation of treatment
effects during statistical analysis.. note, intercurrent events should not be actively avoided.
CRA (Monitor)
Receive documented approval/favorable opinion by the IRB/IEC prior to enrollment. Then
ensure the subjs LAR is informed asap to continue the consent
Definition 11 of 78
-Therapeutic use, begins after drug approval
-Tx is approved and available, but still evaluating for long term effects
-Phase IV trials usually require more subjects and data collection than phase III trials
IRB/IEC Evaluates
Phase III
Expected AEs
Phase IV
Term 12 of 78
Subjects can be enrolled using lab results predating when the ICF was signed (T/F)
to obtain the subject's reason for withdrawal
the subjects must be reconsented and the irb/iec should be informed and approve the
changes if the trial is to continue
False
True
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