WELL DETAILED ANSWERS|LATEST
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, CORRECT WELL DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
21 CFR Part 11 - ANSWER Electronic Records; Electronic Signatures
21 CFR 50 - ANSWER Protection of Human Subjets/Informed Consent
21 CFR 56 - ANSWER Institutional Review Boards
21 CFR 312 - ANSWER Investigational New Drug Application
21 CFR 812 - ANSWER Investigational Device Exemptions
Biometrics - ANSWER A method of verifying an individual's identity based on
measurement of the individual's physical features or repeatable actions where those
features and or actions are both unique to that individual and measurable (21 CFR 11)
Closed System - ANSWER An environment in which system access is controlled by
persons who are responsible for the content of electronic records that are on the system (21
CFR 11)
Digital Signature - ANSWER An electronic signature based upon cryptographic
methods of originator authentication, computer by using a set of rules and a set of
parameters such that the identity of the signer and the integrity of the data can be verified
(21 CFR 11)
2
, 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 the handwritten signature (21 CFR 11)
Open System - ANSWER An environment in which system access is not controlled by
persons who are responsible for the content of electronic records that are on the system (21
CFR 11)
Minimal Risk - ANSWER The probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or psychological
examinations or tests
Assent - ANSWER A child's affirmative agreement to participate in a clinical
investigation
Elements of Informed Consent (8) - ANSWER 1. Statement that the study involved
research, Explanation of the purpose, Expected duration, Description & Identification of
procedures
2. Description of any reasonably foreseeable risks or discomforts
3. Description of any benefits
4. Disclosure of appropriate alternative procedures
5. Statement describing extent of confidentiality of records identifying subject will be
maintained
6. Research involving more than minimal risk: Whether any compensation is available &
Explanation whether medical treatments are available if injury occurs
7. Explanation of whom to contact for research questions
8. Statement participation is voluntary
(21 CFR 50)
3
CORRECT = 100
100
INCORRECT=0
STUDY MATERIALS.......DESIGNED TO HELP YOU SUCCEED
SPOTLIGHT 1
1
, CORRECT WELL DETAILED ANSWERS|LATEST
UPDATE!!!!!!2026|GUARANTEED PASS|GRADED
21 CFR Part 11 - ANSWER Electronic Records; Electronic Signatures
21 CFR 50 - ANSWER Protection of Human Subjets/Informed Consent
21 CFR 56 - ANSWER Institutional Review Boards
21 CFR 312 - ANSWER Investigational New Drug Application
21 CFR 812 - ANSWER Investigational Device Exemptions
Biometrics - ANSWER A method of verifying an individual's identity based on
measurement of the individual's physical features or repeatable actions where those
features and or actions are both unique to that individual and measurable (21 CFR 11)
Closed System - ANSWER An environment in which system access is controlled by
persons who are responsible for the content of electronic records that are on the system (21
CFR 11)
Digital Signature - ANSWER An electronic signature based upon cryptographic
methods of originator authentication, computer by using a set of rules and a set of
parameters such that the identity of the signer and the integrity of the data can be verified
(21 CFR 11)
2
, 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 the handwritten signature (21 CFR 11)
Open System - ANSWER An environment in which system access is not controlled by
persons who are responsible for the content of electronic records that are on the system (21
CFR 11)
Minimal Risk - ANSWER The probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or psychological
examinations or tests
Assent - ANSWER A child's affirmative agreement to participate in a clinical
investigation
Elements of Informed Consent (8) - ANSWER 1. Statement that the study involved
research, Explanation of the purpose, Expected duration, Description & Identification of
procedures
2. Description of any reasonably foreseeable risks or discomforts
3. Description of any benefits
4. Disclosure of appropriate alternative procedures
5. Statement describing extent of confidentiality of records identifying subject will be
maintained
6. Research involving more than minimal risk: Whether any compensation is available &
Explanation whether medical treatments are available if injury occurs
7. Explanation of whom to contact for research questions
8. Statement participation is voluntary
(21 CFR 50)
3
