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CCRP (Certified Clinical Research Professional) SOCRA Certification Problem set Exam Questions with all answers Correctly provided Latest 2024/2025 CA$17.39   Add to cart
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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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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 ...

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  • November 5, 2024
  • 23
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • report fda and irb
  • social isolation
  • stress management
  • ide investigational device exemption
  • 21 cfr part 312 vs 21 cfr part 812
  • cardiac effects of nicotine
  • ccrp certified clinical research professional

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  • CCRP SOCRA
  • CCRP SOCRA

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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


Foods that raise insulin levels have... - correct answer added
sugar


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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