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CCRP (Certified Clinical Research Professional) SOCRA Certification Problem set Exam Questions with all answers Correctly provided Latest 2024/2025£9.74
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CCRP (Certified Clinical Research Professional) SOCRA Certification Problem set Exam Questions with all answers Correctly provided Latest 2024/2025
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Module
CCRP SOCRA
Institution
CCRP SOCRA
CCRP (Certified Clinical Research Professional) SOCRA Certification Problem set Exam Questions with all answers Correctly provided Latest 2024/2025
Minimal risk - correct answer the likelihood of harm is no greater than that encountered in daily life or during routine PE
IDE (Investigational ...
CCRP (Certified Clinical Research
Professional) SOCRA Certification Problem
set Exam Questions with all answers Correctly
provided Latest 2024/2025
Minimal risk - correct answer the likelihood of harm is no
greater than that encountered in daily life or during routine PE
IDE (Investigational Device Exemption) - correct answer an
approved IDE permits device to be shipped lawfully
21 CFR Part 312 vs 21 CFR Part 812 - correct answer 21 CFR
Part 312 = FDA Form 1572, Serious Adverse Event
21 CFR Part 812 = Investigational agreement, Unanticipated
Adverse Device Effects
How many days do you have to report a deviation from an
investigational device plan to Sponsor and IRB, and why? -
correct answer Five days. Deviations are to protect human life
or physical well-being
How many days do you have to report an unanticipated adverse
device effect? - correct answer As soon as possible, but no later
than 10 days after Investigator first learns of the event
What must a Sponsor do if they determine that the
investigational product presents significant and unreasonable
risk to Subjects? - correct answer 1.) Immediately discontinue
all studies that present risk
,2.) Report FDA and IRB
3.) Assure return and accounting for all investigational
products/devices
Sponsor responsiblities - correct answer 1.) Maintain an
effective IND or IDE
2.) Ensure studies are conducted according to the general
investigative plan and protocols in IND/IDE
3.) Promptly report adverse events
4.) Select qualified Investigators
5.) Provide information such as: investigative brochures
6.) Ensure proper monitoring (medical monitor, DSMB, on-site
monitoring)
7.) Manufacture and label drug/device
What must the Sponsor obtain from the Investigator prior to
start of study? - correct answer Signed Investigator Statement
(Form FDA 1572)
CVs
Phase 1: Clinical protocol
Phase 2/3: Protocol outline with approximate number of subjects
to get treatment & number to be used as controls (sex, age, and
condition)
Financial Disclosure
Equity interest in publicly traded company greater than $____
should be reported? - correct answer $50,000
, How long is the reporting period for equity interest and
significant payments? - correct answer Study period plus one
year
What influences a persons metabolic rate? - correct answer
Exercise, gender, genetics, age
Which is the macronutrient that provides more than twice as
many calories as the other two - correct answer Fat
When feeling stressed, you may feel relief after eating a piece of
chocolate because... - correct answer it will raise dopamine
levels
What reduces the number of receptors for dopamine - correct
answer insulin
What percentage of Cardiac Rehab patients re overweight or
obese - correct answer 80%
Why is fructose a promoter of obesity? - correct answer
promotes liver fat accumulation which promotes metabolic
syndrome
What reduces the rate of carbohydrate absorption thus reducing
insulin response - correct answer Fiber
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