21 CFR part 11 regulates?- ✔ Answer ✔ -Electronic Signatures
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.
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:- ✔ Answer ✔ -E:
Efficacy
S: Safety
Q: Quality
M: Multidisciplinary
What does 21CFR50 section 812 regulate?- ✔ Answer ✔ -Investigational Device Exemptions
There are 8 ICH GCP guidelines. The first is the glossary and the second is the principles of GCP. What
are the other 6 guidelines?- ✔ Answer ✔ -3. IRB/IEC
4. Investigator
5. Sponsor
6. Protocol and protocol amendments
7. Investigator's Brochure
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.
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:- ✔ Answer ✔ -E:
Efficacy
S: Safety
Q: Quality
M: Multidisciplinary
What does 21CFR50 section 812 regulate?- ✔ Answer ✔ -Investigational Device Exemptions
There are 8 ICH GCP guidelines. The first is the glossary and the second is the principles of GCP. What
are the other 6 guidelines?- ✔ Answer ✔ -3. IRB/IEC
4. Investigator
5. Sponsor
6. Protocol and protocol amendments
7. Investigator's Brochure
