SOCRA CCRP PRACTICE EXAM | QUESTIONS AND ANSWERS |
VERIFIED ANSWERS | LATEST EXAM UPDATE
21 CFR part 11 regulates? - CORRECT ANSWER - Electronic Signatures
What is the name of FDA Form 483? - CORRECT ANSWER - Inspectional
Observation
What does 21CFR56 regulate? - CORRECT ANSWER - Institutional Review
Boards
An application for Investigational Device Exemption is part of 21 CFR part
____________? - CORRECT ANSWER - 812
Define Electronic Signature - CORRECT 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? - CORRECT
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. -
CORRECT ANSWER - True
,What does 21CFR50 regulate? - CORRECT ANSWER - FDA Protection of
Human Subjects
In 21CFR11.1, subpart A, what requirements must electronic records meet? -
CORRECT ANSWER - They must be in accordance with part 11.2, unless
paper records are specifically required
Define Clinical Investigation: - CORRECT 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. - CORRECT 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? - CORRECT ANSWER - Electronic
Records
What is another name for ICH guideline is E6? - CORRECT ANSWER - GCP
(Good Clinical Practice)
True or False? 21CFR50 refers to protection of human rights that also regulate
food additives - CORRECT 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? - CORRECT ANSWER - Investigational
New Drug
When it comes to electronic signatures, how many identification components
are required? Please list examples: - CORRECT ANSWER - At least two;
identification code and password
In 21CFR50, subpart A, under general provisions, which part refers to an
investigational new drug? - CORRECT ANSWER - Part 312
IRB must register under which federal department? - CORRECT ANSWER -
Department of Health and Human Services
21CFR50 subpart B refers to ____________________? - CORRECT
ANSWER - Informed consent
List 4 requirements that make informed consent feasible when a signature
cannot be obtained prior to investigation listed in 21CFR50: - CORRECT
ANSWER - 1. The human subject is confronted by a life-threatening situation
necessitating the use of the test article.
2. Informed consent cannot be obtained from the subject because of an inability
to communicate with the subject.
3. Time is not sufficient to obtain consent from the subject's LAR.
VERIFIED ANSWERS | LATEST EXAM UPDATE
21 CFR part 11 regulates? - CORRECT ANSWER - Electronic Signatures
What is the name of FDA Form 483? - CORRECT ANSWER - Inspectional
Observation
What does 21CFR56 regulate? - CORRECT ANSWER - Institutional Review
Boards
An application for Investigational Device Exemption is part of 21 CFR part
____________? - CORRECT ANSWER - 812
Define Electronic Signature - CORRECT 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? - CORRECT
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. -
CORRECT ANSWER - True
,What does 21CFR50 regulate? - CORRECT ANSWER - FDA Protection of
Human Subjects
In 21CFR11.1, subpart A, what requirements must electronic records meet? -
CORRECT ANSWER - They must be in accordance with part 11.2, unless
paper records are specifically required
Define Clinical Investigation: - CORRECT 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. - CORRECT 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? - CORRECT ANSWER - Electronic
Records
What is another name for ICH guideline is E6? - CORRECT ANSWER - GCP
(Good Clinical Practice)
True or False? 21CFR50 refers to protection of human rights that also regulate
food additives - CORRECT 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? - CORRECT ANSWER - Investigational
New Drug
When it comes to electronic signatures, how many identification components
are required? Please list examples: - CORRECT ANSWER - At least two;
identification code and password
In 21CFR50, subpart A, under general provisions, which part refers to an
investigational new drug? - CORRECT ANSWER - Part 312
IRB must register under which federal department? - CORRECT ANSWER -
Department of Health and Human Services
21CFR50 subpart B refers to ____________________? - CORRECT
ANSWER - Informed consent
List 4 requirements that make informed consent feasible when a signature
cannot be obtained prior to investigation listed in 21CFR50: - CORRECT
ANSWER - 1. The human subject is confronted by a life-threatening situation
necessitating the use of the test article.
2. Informed consent cannot be obtained from the subject because of an inability
to communicate with the subject.
3. Time is not sufficient to obtain consent from the subject's LAR.
