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CCRP SoCRA Problem set study Exam Questions and Correct Answers Guaranteed Success 2024/2025
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CCRP SoCRA Problem set study Exam Questions and Correct Answers Guaranteed Success 2024/2025 FDA Form 3454 - correct answer Certification - Financial Interests and Arrangements of Clinical Investigators FDA Form 3455 - correct answer Disclosure - Financial Interests and Arrangements of Clinic...

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Document information

  • November 5, 2024
  • 12
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • fda form 3454
  • covered clinical trial
  • financial recordkeeping
  • investigators brochure
  • declaration
  • significant equity interest
  • essential documents before trial investigator
  • summary of the nuremberg code

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  • CCRP SOCRA
  • CCRP SOCRA

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CCRP SoCRA Problem set study Exam
Questions and Correct Answers Guaranteed
Success 2024/2025

FDA Form 3454 - correct answer Certification - Financial
Interests and Arrangements of Clinical Investigators


FDA Form 3455 - correct answer Disclosure - Financial
Interests and Arrangements of Clinical Investigators


Significant Equity Interest - correct answer Significant equity
interest in the sponsor of a covered study means any ownership
interest, stock options, or other financial interest whose value
cannot be readily determined through reference to public prices
or any equity interest in a publicly traded corporation that
exceeds $50k during the time the clinical investigator is carrying
out the study and for 1 year following completion. (21 CFR 54.2)


Significant Payments - correct answer Significant payments of
other sorts means payments made by the sponsor of a covered
study to the investigator or the institution to support activities of
the investigator that have a monetary value of more than
$25,000, exclusive of the costs of conducting the clinical study or
other clinical studies, (e.g., a grant to fund ongoing research,
compensation in the form of equipment or retainers for ongoing
consultation or honoraria) during the time the clinical
investigator is carrying out the study and for 1 year following the
completion of the study. (21 CFR 54.2)

, Covered Clinical Trial - correct answer Covered clinical study
means any study of a drug or device in humans submitted in a
marketing application or reclassification petition subject to this
part that the applicant or FDA relies on to establish that the
product is effective (including studies that show equivalence to
an effective product) or any study in which a single investigator
makes a significant contribution to the demonstration of safety.
This would, in general, not include phase l tolerance studies or
pharmacokinetic studies, most clinical pharmacology studies
(unless they are critical to an efficacy determination), large open
safety studies conducted at multiple sites, treatment protocols,
and parallel track protocols. An applicant may consult with FDA
as to which clinical studies constitute "covered clinical studies"
for purposes of complying with financial disclosure requirements.
(21 CFR 54.2)


Financial Recordkeeping - correct answer 1. Records showing
any financial interest paid to investigator by the sponsor
2. Records showing significant payments of other sorts made by
the sponsor to the investigator
3. Records showing any financial interests held by clinical
investigators
(21 CFR 54.6)


Elements of the Investigator's Brochure - correct answer 1.
Brief description of drug substance and formulation
2. Summary of the pharmacological and toxicological effects of
the drug in animals and humans
3. Summary of the pharmacokinetics and biological disposition in
animals and humans
4. Summary of information relating to safety and effectiveness in
humans obtained from prior trials

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