ACRP CCRA ANSWERS AND QUESTIONS SET A+
✔✔The following are examples of what type of costs? Examples: drug dispensing fees,
sample preparation, supply costs, copies of diagnostic test, subject stipends, shipping
costs, subject injury monitoring, space utilization, and training. - ✔✔Hidden costs
✔✔True or False? Sites should prepare internal budget that's detailed and includes
actual costs. Internal budget should be provided by sponsor. - ✔✔False
✔✔A study protocol provides? - ✔✔A plan for a scientific experiment or for medical
treatment.
✔✔Protocol design starts with? - ✔✔Identifying gab in knowledge.
✔✔Consideration not found in protocol is? - ✔✔Funding
✔✔Activity present in research (scientific) is? - ✔✔Exploratory data collection, analysis,
and hypothesis testing.
✔✔Hypothesis testing involves? - ✔✔Determination if possible relationship among
variable is indeed true.
✔✔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? - ✔✔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
✔✔Data manager calls investigator saying fraud has been committed. Did the data
manager act as they should? - ✔✔No
✔✔The following are examples of what type of costs? Examples: drug dispensing fees,
sample preparation, supply costs, copies of diagnostic test, subject stipends, shipping
costs, subject injury monitoring, space utilization, and training. - ✔✔Hidden costs
✔✔True or False? Sites should prepare internal budget that's detailed and includes
actual costs. Internal budget should be provided by sponsor. - ✔✔False
✔✔A study protocol provides? - ✔✔A plan for a scientific experiment or for medical
treatment.
✔✔Protocol design starts with? - ✔✔Identifying gab in knowledge.
✔✔Consideration not found in protocol is? - ✔✔Funding
✔✔Activity present in research (scientific) is? - ✔✔Exploratory data collection, analysis,
and hypothesis testing.
✔✔Hypothesis testing involves? - ✔✔Determination if possible relationship among
variable is indeed true.
✔✔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? - ✔✔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
✔✔Data manager calls investigator saying fraud has been committed. Did the data
manager act as they should? - ✔✔No
