SOCRA CCRP Exam Practice
,21 CFR part 11 regulates? - CORRECT ANSWERS-Electronic Signatures
What is the name of FDA Form 483? - CORRECT ANSWERS-Inspectional Observation
What does 21CFR56 regulate? - CORRECT ANSWERS-Institutional Review Boards
An application for Investigational Device Exemption is part of 21 CFR part
____________? - CORRECT ANSWERS-812
Define Electronic Signature - CORRECT ANSWERS-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
ANSWERS-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 ANSWERS-True
What does 21CFR50 regulate? - CORRECT ANSWERS-FDA Protection of Human
Subjects
In 21CFR11.1, subpart A, what requirements must electronic records meet? -
CORRECT ANSWERS-They must be in accordance with part 11.2, unless paper
records are specifically required
Define Clinical Investigation: - CORRECT ANSWERS-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 ANSWERS-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 ANSWERS-Electronic Records
What is another name for ICH guideline is E6? - CORRECT ANSWERS-GCP (Good
Clinical Practice)
, True or False? 21CFR50 refers to protection of human rights that also regulate food
additives - CORRECT ANSWERS-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 ANSWERS-Investigational New Drug
When it comes to electronic signatures, how many identification components are
required? Please list examples: - CORRECT ANSWERS-At least two; identification
code and password
In 21CFR50, subpart A, under general provisions, which part refers to an investigational
new drug? - CORRECT ANSWERS-Part 312
IRB must register under which federal department? - CORRECT ANSWERS-
Department of Health and Human Services
21CFR50 subpart B refers to ____________________? - CORRECT ANSWERS-
Informed consent
List 4 requirements that make informed consent feasible when a signature cannot be
obtained prior to investigation listed in 21CFR50: - CORRECT ANSWERS-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.
4. There is no available alternative method of approved or generally recognized therapy
that provides an equal or greater likelihood of saving the life of the subject
ICH has four main categories, under which all guidelines are found. Name these: -
CORRECT ANSWERS-E: Efficacy
S: Safety
Q: Quality
M: Multidisciplinary
What does 21CFR50 section 812 regulate? - CORRECT ANSWERS-Investigational
Device Exemptions
,21 CFR part 11 regulates? - CORRECT ANSWERS-Electronic Signatures
What is the name of FDA Form 483? - CORRECT ANSWERS-Inspectional Observation
What does 21CFR56 regulate? - CORRECT ANSWERS-Institutional Review Boards
An application for Investigational Device Exemption is part of 21 CFR part
____________? - CORRECT ANSWERS-812
Define Electronic Signature - CORRECT ANSWERS-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
ANSWERS-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 ANSWERS-True
What does 21CFR50 regulate? - CORRECT ANSWERS-FDA Protection of Human
Subjects
In 21CFR11.1, subpart A, what requirements must electronic records meet? -
CORRECT ANSWERS-They must be in accordance with part 11.2, unless paper
records are specifically required
Define Clinical Investigation: - CORRECT ANSWERS-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 ANSWERS-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 ANSWERS-Electronic Records
What is another name for ICH guideline is E6? - CORRECT ANSWERS-GCP (Good
Clinical Practice)
, True or False? 21CFR50 refers to protection of human rights that also regulate food
additives - CORRECT ANSWERS-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 ANSWERS-Investigational New Drug
When it comes to electronic signatures, how many identification components are
required? Please list examples: - CORRECT ANSWERS-At least two; identification
code and password
In 21CFR50, subpart A, under general provisions, which part refers to an investigational
new drug? - CORRECT ANSWERS-Part 312
IRB must register under which federal department? - CORRECT ANSWERS-
Department of Health and Human Services
21CFR50 subpart B refers to ____________________? - CORRECT ANSWERS-
Informed consent
List 4 requirements that make informed consent feasible when a signature cannot be
obtained prior to investigation listed in 21CFR50: - CORRECT ANSWERS-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.
4. There is no available alternative method of approved or generally recognized therapy
that provides an equal or greater likelihood of saving the life of the subject
ICH has four main categories, under which all guidelines are found. Name these: -
CORRECT ANSWERS-E: Efficacy
S: Safety
Q: Quality
M: Multidisciplinary
What does 21CFR50 section 812 regulate? - CORRECT ANSWERS-Investigational
Device Exemptions
