Which of the following is a disclosure of financial interests form? - ANSWER FDA Form 3455
Which of the following is a certification of financial interest form? - ANSWER FDA Form 3454
If the investigator did have f
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Which of the following is a disclosure of financial interests form? - ANSWER FDA Form 3455
Which of the following is a certification of financial interest form? - ANSWER FDA Form 3454
If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: - ANSWER FDA Form 3455
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSWER Investigational New Drug Application (1571)
In the top right corner, form have OMB number. What does it stand for? - ANSWER Office of Management and Budget
The form, which is submitted to the FDA to report an Adverse Event is - ANSWER 3500
Medical device adverse events/problems are reported via a form: - ANSWER 3500A
What is FDA form 1571? - ANSWER Cover-sheet for Investigational New Drug Applications
21 CFR 312 deals with - ANSWER Investigational New Drug Application
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 with the statement - ANSWER "Caution: New Drug—Limited by Federal (or United States) law to investigational use."
Which of the following is not listed on FDA form 1571: - ANSWER 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 Life threatening adverse drug experience
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.
What is a drug as defined by the FDA? - ANSWER A 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? - ANSWER 20-80: Typical number of healthy volunteers used in Phase 1: this phase emphasizes SAFETY.
What is Phase 2 of a clinical trial? - ANSWER 100s: Typical number of patients used in Phase 2; this phase emphasizes EFFECTIVENESS
What is Phase 3 of a clinical trial? - ANSWER 1000's :Typical number of patients used in 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.
What is Phase 4 of a clinical trial? - ANSWER Post Marketing: Because it's not possible to predict all of a drug's effects during clinical trials, monitoring safety issues after drugs get on the market is critical. The role of FDA's post-marketing safety system is to detect serious unexpected adverse events and take definitive action when needed.
The main concept of 21 CFR 50 is - ANSWER Protection of Human Subjects
Subpart D of 21 CFR 50 lists the - ANSWER Additional Safeguards for children in Clinical Investigations
The FDA may restrict, suspend, or terminate an institution's or IRB's use of the expedited review procedure when necessary to protect the rights or welfare of subject - ANSWER a. true X (21 CFR 56.110 Subpart D)
b. false
A Phase ___ protocol is more flexible and less detailed than the others. - ANSWER Phase 1
A source document is any document found that is associated with a clinical trial. - ANSWER a. true
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