Exam (elaborations)
Practice Questions for SOCRA exam VERIFIED 2022/2023
- Course
- SOCRA
- Institution
- Chamberlain College Of Nursing
Practice Questions for SOCRA exam VERIFIED 2022/2023
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Practice Questions for SOCRA examlatest
Which of the following is a disclosure of financial interests form? correct answer
Which of the following is a certification of financial interest form? correct answer
If the investigator did have financial arrangement with the sponsor, he/she would submit the following
form: correct answer
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial correct
answerInvestigational New Drug Application
In the top right corner, form have OMB number. What does it stand for? correct answer
The form, which is submitted to the FDA to report an Adverse Event is correct answer
Medical device adverse events/problems are reported via a form: correct answer
What is FDA form 1571? correct answer
21 CFR 312 deals with correct answer
Investigational new drug means correct answerA new drug or biological drug that is used in a clinical
investigation
The immediate package of an investigational new drug intended for human use shall bear a label wit the
statement correct answer
, Which of the following is not listed on FDA form 1571: correct answera. name, address, phone number
of the sponsor
b. a commitment not to start the clinical investifation until the InD is in effect
c. identification of the phase of the trail
d. approved informed consent document
"Any adverse drug experience that places the patient or subject, in the view of the investigator, at
immediate risk of death from the reaction as it occurred" Is... correct answera. serious adverse drug
experience
b. life threatening adverse drug experience
c. none of the above
What are the three main basic ethical principles of the Belmont Report? correct answer1. Respect for
Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? correct answer1. Informed Consent
2. Assessment of Risk and Benefits
3. Selection of Subjects
What phrase of a drug trial usually includes hundreds to thousands of volunteers? correct answerPhase
3: These studies gather more information about safety and effectiveness, study different populations
and different dosages, and uses the drug in combination with other drugs.
What is a drug as defined by the FDA? correct answerA drug is an product that is intended for use in the
diagnosis, cure mitigation, treatment, or prevention of disease; and that is intended to affect the
structure or any function of the body.
What is Phase 1 of a clinical trial? correct answer20-80: Typical number of healthy volunteers used in
Phase 1: this phase emphasizes SAFETY.
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