ACRP CCRA Actual Final Exam Newest / ACRP CCRA Exam
Preparation / ACRP CCRA Practice Exam With Complete 200
Questions And Correct Detailed Answers |Already Graded
A+(Newest Version!)
What key ares should be included for consideration in development by sponsor or investor? -
answer-;- Creation and modification of systems from sponsor or investigator
- Creation, modification and transfer for data from sponsor or investigator
- Control, copying and storage
Examples of electronic signature? - answer-;Signature linked to password
When a site utilizes electronic medical or health records, the purpose and significance include? -
answer-;- Collection of patient data on site
- Allows review of 'charts' by all physician who have access
- Allows for legibility
eCRFs when used as source should enhance? - answer-;- Remote review by sponsor
- Timing of completion of data entry
- Faster data review and cleaning (queries)
True or False? The investigator should NOT attempt to negotiate clinical trial budget with
sponsor. - answer-;False
In an industry initiated clinical trial, the budget should contain three independent sections
which comprise the overall study budget. - answer-;- Start-up costs
,- Per-subject costs
- Variable costs
True or False? In an industry initiated clinical trial, the site should ask sponsor for an advance vs
start-up costs. - answer-;False
What's the most critical document for site to read and understand before attempting to draft a
budget? - answer-;Protocol
True or False? Indirect cost should only be charged on per-subject costs. - answer-;False
This budget section should include all necessary site cost before study is ready to enroll it's first
subject and be non-refundable. How are these costs defined. - answer-;Start-up costs
True or False? The charge to sponsor should be the actual cost of protocol required items or
services. - answer-;False
The following is incorporated into clinical trial agreement and defines when site will be paid for
study performance. - answer-;Payment terms
True or False? The site should review sponsors budget before drafting own site budget. -
answer-;False
During the budget preparation phase, the site should? - answer-;- Analyze protocol
- Determine study services
- Obtain necessary clarifications from sponsor
- Analyze CRF
,True or False? Protocol amendments are from changes to protocol. The site does NOT need to
evaluate the budget to determine if a budget amendment is required. - answer-;False
This budget section should include all services that may or may NOT occur during course of
study (sponsor to be invoiced if they occur) - answer-;Variable costs
True of False? The per subject cost section of budget should include cost for one single
completed subject. - answer-;True
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. - answer-;Hidden costs
True or False? Sites should prepare internal budget that's detailed and includes actual costs.
Internal budget should be provided by sponsor. - answer-;False
A study protocol provides? - answer-;A plan for a scientific experiment or for medical
treatment.
Protocol design starts with? - answer-;Identifying gab in knowledge.
Consideration not found in protocol is? - answer-;Funding
Activity present in research (scientific) is? - answer-;Exploratory data collection, analysis, and
hypothesis testing.
Hypothesis testing involves? - answer-;Determination if possible relationship among variable is
indeed true.
, Study protocol is composed of? - answer-;- Background
- Purpose
- Methods
Hypothesis can be used for assessing opening a study at a site in which way? - answer-
;Hypothesis can judge scientific merit and site interest in study.
How many categorizes are in research design? - answer-;Four
Population, case-control, and cohort studies are what type of study? - answer-;Observational
How do population studies differ from case-control? - answer-;Larger in sample size.
Randomized Controlled Trials (RCTs) differ from other study types in what way? - answer-;-
Greatest level of interaction with participant
- Greatest involvement with investigator
- Most complex design and structure
In terms of risk? - answer-;All studies carry some degree, even if minimal.
Risk related to study can involve what aspect? - answer-;- Risk of study participants
- Risk of study integrity
Why is statistics considered risk in study design and feasibility assessment? - answer-;Statistics
used to ensure adequate same size for avoiding unnecessary risk.
Other considerations for study design and feasibility assessment? - answer-;- Ethics
Preparation / ACRP CCRA Practice Exam With Complete 200
Questions And Correct Detailed Answers |Already Graded
A+(Newest Version!)
What key ares should be included for consideration in development by sponsor or investor? -
answer-;- Creation and modification of systems from sponsor or investigator
- Creation, modification and transfer for data from sponsor or investigator
- Control, copying and storage
Examples of electronic signature? - answer-;Signature linked to password
When a site utilizes electronic medical or health records, the purpose and significance include? -
answer-;- Collection of patient data on site
- Allows review of 'charts' by all physician who have access
- Allows for legibility
eCRFs when used as source should enhance? - answer-;- Remote review by sponsor
- Timing of completion of data entry
- Faster data review and cleaning (queries)
True or False? The investigator should NOT attempt to negotiate clinical trial budget with
sponsor. - answer-;False
In an industry initiated clinical trial, the budget should contain three independent sections
which comprise the overall study budget. - answer-;- Start-up costs
,- Per-subject costs
- Variable costs
True or False? In an industry initiated clinical trial, the site should ask sponsor for an advance vs
start-up costs. - answer-;False
What's the most critical document for site to read and understand before attempting to draft a
budget? - answer-;Protocol
True or False? Indirect cost should only be charged on per-subject costs. - answer-;False
This budget section should include all necessary site cost before study is ready to enroll it's first
subject and be non-refundable. How are these costs defined. - answer-;Start-up costs
True or False? The charge to sponsor should be the actual cost of protocol required items or
services. - answer-;False
The following is incorporated into clinical trial agreement and defines when site will be paid for
study performance. - answer-;Payment terms
True or False? The site should review sponsors budget before drafting own site budget. -
answer-;False
During the budget preparation phase, the site should? - answer-;- Analyze protocol
- Determine study services
- Obtain necessary clarifications from sponsor
- Analyze CRF
,True or False? Protocol amendments are from changes to protocol. The site does NOT need to
evaluate the budget to determine if a budget amendment is required. - answer-;False
This budget section should include all services that may or may NOT occur during course of
study (sponsor to be invoiced if they occur) - answer-;Variable costs
True of False? The per subject cost section of budget should include cost for one single
completed subject. - answer-;True
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. - answer-;Hidden costs
True or False? Sites should prepare internal budget that's detailed and includes actual costs.
Internal budget should be provided by sponsor. - answer-;False
A study protocol provides? - answer-;A plan for a scientific experiment or for medical
treatment.
Protocol design starts with? - answer-;Identifying gab in knowledge.
Consideration not found in protocol is? - answer-;Funding
Activity present in research (scientific) is? - answer-;Exploratory data collection, analysis, and
hypothesis testing.
Hypothesis testing involves? - answer-;Determination if possible relationship among variable is
indeed true.
, Study protocol is composed of? - answer-;- Background
- Purpose
- Methods
Hypothesis can be used for assessing opening a study at a site in which way? - answer-
;Hypothesis can judge scientific merit and site interest in study.
How many categorizes are in research design? - answer-;Four
Population, case-control, and cohort studies are what type of study? - answer-;Observational
How do population studies differ from case-control? - answer-;Larger in sample size.
Randomized Controlled Trials (RCTs) differ from other study types in what way? - answer-;-
Greatest level of interaction with participant
- Greatest involvement with investigator
- Most complex design and structure
In terms of risk? - answer-;All studies carry some degree, even if minimal.
Risk related to study can involve what aspect? - answer-;- Risk of study participants
- Risk of study integrity
Why is statistics considered risk in study design and feasibility assessment? - answer-;Statistics
used to ensure adequate same size for avoiding unnecessary risk.
Other considerations for study design and feasibility assessment? - answer-;- Ethics
