SoCRA Certification
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In order to understand a 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 exam. Give it a shot!
- 1.What is FDA form 1571?
- A.
Statement of investigator
- B.
Cover sheet for Investigational New Drug application
- C.
Disclosure of financial interests of clinical investigators
- D.
Investigator's brochure application
- 2.21 CFR 312 deals with
- A.
Investigational device exemptions
- B.
Protection of human subjects/ informed consent
- C.
Investigational New Drug application
- D.
IRB protocols
- 3.Investigational new drug means
- A.
A new drug or biological drug that is used in a clinical investigation,
- B.
The method of labeling bottles of medication with unknown side effects.
- C.
Test marketing new drugs.
- 4.The immediate package of an investigational new drug intended for human use shall bear a label with the statement
- A.
"Caution: for FDA research purposes only"
- B.
"Caution: New drug-- limited known side effects"
- C.
"Caution: New Drug-- Limited by Federal (or United States) law to investigational use."
- D.
None of the above
- 5.Which of the following is not listed on FDA form 1571:
- A.
Name, address, phone number of the sponsor
- B.
A commitment not to start the clinical investigation until the IND is in effect
- C.
Identification of the phase of the trial
- D.
Approved informed consent document
- 6."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
- A.
Serious adverse drug experience
- B.
Life threatening adverse drug experience
- C.
None of the above
- 7.The Belmont report consists of three main principles: beneficence, respect of persons, and ______________.
- 8.What phase of a drug trial usually includes hundreds to thousands of volunteers?
- 9.The main concept of 21 CFR 50 is
- A.
IRB regulations
- B.
Protection of human subjects
- C.
Financial disclosure
- D.
Electronic records
- 10.Subpart D of 21 CFR 50 lists the
- A.
Safe guards of children
- B.
Informed consent
- C.
Rights of prisoners as research subjects
- D.
Other not listed above
- 11.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 subjects.
- A.
True
- B.
False
- 12.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.
- 13.A source document is any document found that is associated with a clinical trial.
- A.
True
- B.
False
- 14.
- A.
IRB approved protocol, IRB approved informed consent form, IRB approval letter, IRB approved recruitment materials
- B.
Signed and completed 1572, CV's and financial disclosures from everyone listed on 1572
- C.
Current lab certifications and normal ranges
- D.
A and B
- E.
All of the above
- 15.Certification of absence of financial interest would also be known as
- A.
Form 3455
- B.
Form 3454
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