In order to understand the disease and the effect of a certain group of medicines have on it, there have to be some clinical trials ran and SOCRA is put in place to protect the welfare of research participants. This is a review of the code of federal regulations- protecting human subjects. Just to help with reviewing for The SOCRA See moreexam. Give it a shot!
Investigational device exemptions
Protection of human subjects/ informed consent
Investigational New Drug application
IRB protocols
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A new drug or biological drug that is used in a clinical investigation,
The method of labeling bottles of medication with unknown side effects.
Test marketing new drugs.
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"Caution: for FDA research purposes only"
"Caution: New drug-- limited known side effects"
"Caution: New Drug-- Limited by Federal (or United States) law to investigational use."
None of the above
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Name, address, phone number of the sponsor
A commitment not to start the clinical investigation until the IND is in effect
Identification of the phase of the trial
Approved informed consent document
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Phase 1
Phase 2
Phase 3
Phase 4
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IRB regulations
Protection of human subjects
Financial disclosure
Electronic records
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Safe guards of children
Informed consent
Rights of prisoners as research subjects
Other not listed above
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True
False
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I
II
III
None of the Phases are flexible.
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True
False
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IRB approved protocol, IRB approved informed consent form, IRB approval letter, IRB approved recruitment materials
Signed and completed 1572, CV's and financial disclosures from everyone listed on 1572
Current lab certifications and normal ranges
A and B
All of the above
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Form 3455
Form 3454
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