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Practice Questions For SOCRA Exam With Complete Solutions 2024/2025
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Practice Questions For SOCRA Exam With Complete Solutions 2024/2025
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Practice Questions For SOCRA Exam WithComplete Solutions 2024/2025
Which of the following is a disclosure of financial interests form? Answer:
Which of the following is a certification of financial interest form? Answer:
If the investigator did have financial arrangement with the sponsor, he/she would submit the following
form: Answer:
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial Answer:
Investigational New Drug Application
In the top right corner, form have OMB number. What does it stand for? Answer:
The form, which is submitted to the FDA to report an Adverse Event is Answer:
Medical device adverse events/problems are reported via a form: Answer:
What is FDA form 1571? Answer:
21 CFR 312 deals with Answer:
Investigational new drug means Answer: A 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 Answer:
Which of the following is not listed on FDA form 1571: Answer: a. 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... Answer: a. 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? Answer: 1. Respect for
Persons
2. Beneficence
3. Justice
What are the applications for the Belmont Report? Answer: 1. 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? Answer: Phase 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.
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