SOCRA CCRP COMPREHENSIVE STUDY GUIDE COMPLETE QUESTIONS AND CORRECT ANSWERS

SOCRA CCRP COMPREHENSIVE STUDY
GUIDE COMPLETE QUESTIONS AND
CORRECT ANSWERS

●● What is the name of FDA Form 483?
Answer: Inspectional Observation


●● What does 21CFR56 regulate?
Answer: Institutional Review Boards


●● An application for Investigational Device Exemption is part of 21
CFR part ____________?
Answer: 812


●● Define Electronic Signature
Answer: A computer data compilation of any symbol or series of
symbols executed, adopted, or authorized by an individual to be legally
binding equivalent of an individual's handwritten signature


●● 21CFR50, subpart D refers to safeguards for which population?
Answer: Children in Clinical Investigations

,●● True or False? The regulations in CFR part 11 set forth the criteria
under which that agency considers electronic records, electronic
signatures, and handwritten signatures to electronic records to be
trustworthy, reliable and generally equivalent to paper records and
handwritten signature executed on paper.
Answer: True


●● What does 21CFR50 regulate?
Answer: FDA Protection of Human Subjects


●● In 21CFR11.1, subpart A, what requirements must electronic records
meet?
Answer: They must be in accordance with part 11.2, unless paper
records are specifically required


●● Define Clinical Investigation:
Answer: Any experiment that involves a test article and one or more
human subjects and that either:
- Is subject to requirements for prior submission to the FDA under
section 505(i) or 520(g)
- Or is not subject to requirements for prior submission but the results of
which are intended to be later submitted
- Or held by inspection by the FDA as a part of an application for a
research or marketing permit

,●● True or False? 21CFR11.2, subpart A is only for electronic records
required to be maintained that must be submitted to an agency.
Answer: False. CFR part 11.2, subpart A is for electronic records
maintenance when submitting to an agency and also when not
submitting to an agency.


●● What does 21CFR11, subpart B cover?
Answer: Electronic Records


●● What is another name for ICH guideline is E6?
Answer: GCP (Good Clinical Practice)


●● True or False? 21CFR50 refers to protection of human rights that
also regulate food additives
Answer: True. This regulation governs:
- Foods, including dietary supplements, that bear a nutrient content
claim or a health claim
- Infant formulas
- Food and color additives
- Drugs for human use
- Medical devices for human use
- Biological products for human use
- Electronic products.

, ●● CFR part 50 section 312 regulates?
Answer: Investigational New Drug


●● When it comes to electronic signatures, how many identification
components are required? Please list examples:
Answer: At least two; identification code and password


●● In 21CFR50, subpart A, under general provisions, which part refers
to an investigational new drug?
Answer: Part 312


●● IRB must register under which federal department?
Answer: Department of Health and Human Services


●● 21CFR50 subpart B refers to ____________________?
Answer: Informed consent


●● List 4 requirements that make informed consent feasible when a
signature cannot be obtained prior to investigation listed in 21CFR50:
Answer: 1. The human subject is confronted by a life-threatening
situation necessitating the use of the test article.