SOCRA CCRP EXAM 2024 NEWEST PRACTICE EXAM
QUESTIONS 450 QUESTIONS WITH DETAILED VERIFIED
ANSWERS (100% CORRECT) /ALREADY GRADED
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.
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
answer) E: Efficacy
S: Safety
Q: Quality
M: Multidisciplinary
What does 21CFR50 section 812 regulate? - (correct answer) Investigational Device
Exemptions
QUESTIONS 450 QUESTIONS WITH DETAILED VERIFIED
ANSWERS (100% CORRECT) /ALREADY GRADED
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.
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
answer) E: Efficacy
S: Safety
Q: Quality
M: Multidisciplinary
What does 21CFR50 section 812 regulate? - (correct answer) Investigational Device
Exemptions
