Practice Questions for SOCRA exam
questions and answers already graded
A+| Updated & Verified | 2024
What is a drug as defined by the FDA? - ✔✔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? - ✔✔20-80: Typical number of healthy volunteers used in Phase 1:
this phase emphasizes SAFETY.
What is Phase 2 of a clinical trial? - ✔✔100s: Typical number of patients used in Phase 2; this
phase emphasizes EFFECTIVENESS
What is Phase 3 of a clinical trial? - ✔✔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? - ✔✔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 - ✔✔
, Subpart D of 21 CFR 50 lists the - ✔✔
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 - ✔✔a. true
b. false
A Phase ___ protocol is more flexible and less detailed than the others. - ✔✔a. I
b. II
c. III
d. None of the phases are flexible.
A source document is any document found that is associated with a clinical trial. - ✔✔a. true
b. false
A sponsor will not ship a study drug until they have received all of the following documents: - ✔✔
Certification of absence of financial interest would also be known as: - ✔✔
What is the minimum number of IRB members? - ✔✔5
The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The
new dosage would be? - ✔✔77
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