ACRP CCRA FINAL EXAM 2025/2026 WITH
ACTUAL CORRECT QUESTIONS AND
VERIFIED DETAILED ANSWERS
|CURRENTLY TESTING QUESTIONS AND
SOLUTIONS|ALREADY GRADED
A+|NEWEST|BRAND NEW
VERSION!!|GUARANTEED PASS
Study protocol is composed of?
- Background
- Purpose
- Methods
Hypothesis can be used for assessing opening a study at a site in which way?
Hypothesis can judge scientific merit and site interest in study.
How many categorizes are in research design?
Four
Population, case-control, and cohort studies are what type of study?
Observational
How do population studies differ from case-control?
Larger in sample size.
Randomized Controlled Trials (RCTs) differ from other study types in what way?
- Greatest level of interaction with participant
- Greatest involvement with investigator
- Most complex design and structure
In terms of risk?
1|Page
,All studies carry some degree, even if minimal.
Risk related to study can involve what aspect?
- Risk of study participants
- Risk of study integrity
Why is statistics considered risk in study design and feasibility assessment?
Statistics used to ensure adequate same size for avoiding unnecessary risk.
Other considerations for study design and feasibility assessment?
- Ethics
- Funding
- Practicality
Funding for study?
Derived from external or internal sources.
Adaptive study design is defined as?
Clinical trials capable of changes in design/feature in response to accumulated data.
Translational research study design defined as?
Predominately takes a bench to bedside approach.
Patient Centered Outcomes Research study design defined as?
Takes into account voice and input for patients.
Comparative effectivness study design defined as?
Research intended to inform healthcare by assessing existing treatments.
Research study design can be utilized in what function?
- Constructing new protocol
- Amending existing study
- Study feasibility assessment
Investigator continues randomizing patient until they received investigators desire product. Is
this ethical?
No
2|Page
,Data manager calls investigator saying fraud has been committed. Did the data manager act as
they should?
No
According to Declaration of Helsinki, where a proven intervention does NOT exist, the
physician...?
May consider an unproven intervention.
Who can detect fraud or misconduct?
Site staff, trial subjects, auditors/inspectors, monitors (CRA), conducting QC, data entry
personnel or data manger, whistle blower, writer of final trial report
Investigator continues postponing meeting because he's busy. Do you consider this unethical
behavior?
Yes
When selecting trial sit for trial, which does the selector need to be vigilant about in regards to
ethics?
Investigator and site staff have potential subjects and resources needed to conduct that
according to protocol.
What are three key principles of Belmont Report?
- Respect for Persons
- Justice
- Beneficience
True or False? Subjects have right to withdraw from experimental trial?
True
True or False? Bribes trip to NY for increased number of enrolled patients. Is this ethical?
False
True or False? Unethical conduct almost never occurs so investigator doesn't need to cross-
check data.
False
Critical elements of patient center care include?
3|Page
, - Informed decision making occurs when communication and education needs are met
- Assessments of comprehension are performed
- Support is provided respective to individual values and needs
What are characteristics of health literacy?
- Obtain, process, understand basic health information
- Relies on cultural and conceptual knowledge
Decisional conflict can be experienced when?
Patient has uncertainty about which course of action to take.
As clinical researchers we can be culturally competent by?
Understanding and acknowledging the difference between various cultures.
What percentage of subjects who sign consent can later recall important elements?
50%
What tip for enhancing understanding during consent process is true?
- Explaining 2-3 concepts at a time
- Giving opportunity for participant to recall information
- Using visual images
Which FDA regulation states that selection of subjects be equitable?
21 CRF 56 III (a) (3)
Which are ways to personally improve in administering informed consent to potential subjects?
- Analyze own communication skills; seek improvement
- Ensure patients interested have information knowledge, behavior needs meet
- Examine SOPs on consent
Acceptable method used to assess subject comprehension of consent form and study?
Teach-back method
What should be considered for all patients during ICF process?
- Emotional state
- Learning style
- Health literacy
A person with LEP?
4|Page
ACTUAL CORRECT QUESTIONS AND
VERIFIED DETAILED ANSWERS
|CURRENTLY TESTING QUESTIONS AND
SOLUTIONS|ALREADY GRADED
A+|NEWEST|BRAND NEW
VERSION!!|GUARANTEED PASS
Study protocol is composed of?
- Background
- Purpose
- Methods
Hypothesis can be used for assessing opening a study at a site in which way?
Hypothesis can judge scientific merit and site interest in study.
How many categorizes are in research design?
Four
Population, case-control, and cohort studies are what type of study?
Observational
How do population studies differ from case-control?
Larger in sample size.
Randomized Controlled Trials (RCTs) differ from other study types in what way?
- Greatest level of interaction with participant
- Greatest involvement with investigator
- Most complex design and structure
In terms of risk?
1|Page
,All studies carry some degree, even if minimal.
Risk related to study can involve what aspect?
- Risk of study participants
- Risk of study integrity
Why is statistics considered risk in study design and feasibility assessment?
Statistics used to ensure adequate same size for avoiding unnecessary risk.
Other considerations for study design and feasibility assessment?
- Ethics
- Funding
- Practicality
Funding for study?
Derived from external or internal sources.
Adaptive study design is defined as?
Clinical trials capable of changes in design/feature in response to accumulated data.
Translational research study design defined as?
Predominately takes a bench to bedside approach.
Patient Centered Outcomes Research study design defined as?
Takes into account voice and input for patients.
Comparative effectivness study design defined as?
Research intended to inform healthcare by assessing existing treatments.
Research study design can be utilized in what function?
- Constructing new protocol
- Amending existing study
- Study feasibility assessment
Investigator continues randomizing patient until they received investigators desire product. Is
this ethical?
No
2|Page
,Data manager calls investigator saying fraud has been committed. Did the data manager act as
they should?
No
According to Declaration of Helsinki, where a proven intervention does NOT exist, the
physician...?
May consider an unproven intervention.
Who can detect fraud or misconduct?
Site staff, trial subjects, auditors/inspectors, monitors (CRA), conducting QC, data entry
personnel or data manger, whistle blower, writer of final trial report
Investigator continues postponing meeting because he's busy. Do you consider this unethical
behavior?
Yes
When selecting trial sit for trial, which does the selector need to be vigilant about in regards to
ethics?
Investigator and site staff have potential subjects and resources needed to conduct that
according to protocol.
What are three key principles of Belmont Report?
- Respect for Persons
- Justice
- Beneficience
True or False? Subjects have right to withdraw from experimental trial?
True
True or False? Bribes trip to NY for increased number of enrolled patients. Is this ethical?
False
True or False? Unethical conduct almost never occurs so investigator doesn't need to cross-
check data.
False
Critical elements of patient center care include?
3|Page
, - Informed decision making occurs when communication and education needs are met
- Assessments of comprehension are performed
- Support is provided respective to individual values and needs
What are characteristics of health literacy?
- Obtain, process, understand basic health information
- Relies on cultural and conceptual knowledge
Decisional conflict can be experienced when?
Patient has uncertainty about which course of action to take.
As clinical researchers we can be culturally competent by?
Understanding and acknowledging the difference between various cultures.
What percentage of subjects who sign consent can later recall important elements?
50%
What tip for enhancing understanding during consent process is true?
- Explaining 2-3 concepts at a time
- Giving opportunity for participant to recall information
- Using visual images
Which FDA regulation states that selection of subjects be equitable?
21 CRF 56 III (a) (3)
Which are ways to personally improve in administering informed consent to potential subjects?
- Analyze own communication skills; seek improvement
- Ensure patients interested have information knowledge, behavior needs meet
- Examine SOPs on consent
Acceptable method used to assess subject comprehension of consent form and study?
Teach-back method
What should be considered for all patients during ICF process?
- Emotional state
- Learning style
- Health literacy
A person with LEP?
4|Page
