SOCRA Exam Questions And Answers
2024
Electronic signature are currently accepted for any and all
records, paper or electronic form. True or False? - correct
answers✅False. The general provisions for electeonic
signature criteria apply to records that are
i. Created, modified, maintained, archived, retrieved, or
transmitted, in electronic form
ii. The criteria do not apply to paper records that are or
have been transmitted by electronic means.
If the electronic records meet the criteria specified in 21
CFR 11, thr agency will consider the electronic signatures,
initials, and other general signing equivalent to full
handwritten signatures, unless specifically excepted by
regulations effective after August 20, 1997. True or False?
- correct answers✅True
Electronic records cannot be used in lieu of paper records.
True or False? - correct answers✅False.
Electronic records that meet the requirements may be
used in lieu of paper forms, unless paper records are
specifically required.
,SOCRA Exam Questions And Answers
2024
provisions are subject to whose inspection? - correct
answers✅The FDA's inspection
Provided they meet the requirements, persons can use
electronic records lieu of paper records, for records
required to be maintained, but not submitted to the
agency. True or False? - correct answers✅True.
Persons can use electronic records in lieu of paper records
for documents required to be submitted to the agency
provided the document has been identified as a type of
submission that the FDA will accept in electronic format. T
or F? - correct answers✅True.
Documents submitted to the FDA that are not specified in
the public docket as acceptable in electronic form, will not
be considered as official if they are submitted in
electronic form. T or F? - correct answers✅True
Who determines the details for electronic submission
(e.g. methods of transmission, media, file formats and
technical protocol)? - correct answers✅The intended
receiving agency unit will determine the details of
electronic submission.
,SOCRA Exam Questions And Answers
2024
In the FDA's regulations covering electronic signatures,
what does the term Act refer to? - correct answers✅Act
means the Federal Food, Drug and Cosmetic Act.
In the FDA's Electronic Signatures regulation, what does
the term agency refer to? - correct answers✅Agency
refers to the Food and Drug Administration
What is the term that means a method of verifying an
individual's identity based on measurement of the
individual's physical feature(s) or repeatable actions(s)
where those features and/or actions are both measurable
and unique to that individual? - correct
answers✅Biometrics
What does the term closed system mean with regard to
electronic records? - correct answers✅Closed system
means environment in which system access is controlled
by persons who are responsible for the content of the
electronic records that are in the system.
An electronic signature is based upon cryptographic
methods of originator authentication, computed 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. T or F? - correct answers✅False.
, SOCRA Exam Questions And Answers
2024
This is the definition for the term digital signature.
Any combination of text, graphics, data, pictorial, audio,
or other information representation in digital form that is
created, modified, maintained, archived, retrieved, or
distributed by a computer system is known as what? -
correct answers✅Electronic Record.
Electronic signature and digital signature are synonymous
terms. or F? - correct answers✅False.
Electronic signature means a computer data complilatiom
of any symbol or series of symbols executed and
authorized by an individual to be the legally binding
equivalent of the handwritten signature. A digital
signature is based upon cryptographic methods or
originator authentication, a set of computed by using
rules and a set of parameters such that the identity of the
signer and the integrity of the data can be verified.
What type of signature is the scripted name or legal mark
of an individual preserved with a writing or marking
instrument such as a pen or stylus? - correct
answers✅Handwritten signature
2024
Electronic signature are currently accepted for any and all
records, paper or electronic form. True or False? - correct
answers✅False. The general provisions for electeonic
signature criteria apply to records that are
i. Created, modified, maintained, archived, retrieved, or
transmitted, in electronic form
ii. The criteria do not apply to paper records that are or
have been transmitted by electronic means.
If the electronic records meet the criteria specified in 21
CFR 11, thr agency will consider the electronic signatures,
initials, and other general signing equivalent to full
handwritten signatures, unless specifically excepted by
regulations effective after August 20, 1997. True or False?
- correct answers✅True
Electronic records cannot be used in lieu of paper records.
True or False? - correct answers✅False.
Electronic records that meet the requirements may be
used in lieu of paper forms, unless paper records are
specifically required.
,SOCRA Exam Questions And Answers
2024
provisions are subject to whose inspection? - correct
answers✅The FDA's inspection
Provided they meet the requirements, persons can use
electronic records lieu of paper records, for records
required to be maintained, but not submitted to the
agency. True or False? - correct answers✅True.
Persons can use electronic records in lieu of paper records
for documents required to be submitted to the agency
provided the document has been identified as a type of
submission that the FDA will accept in electronic format. T
or F? - correct answers✅True.
Documents submitted to the FDA that are not specified in
the public docket as acceptable in electronic form, will not
be considered as official if they are submitted in
electronic form. T or F? - correct answers✅True
Who determines the details for electronic submission
(e.g. methods of transmission, media, file formats and
technical protocol)? - correct answers✅The intended
receiving agency unit will determine the details of
electronic submission.
,SOCRA Exam Questions And Answers
2024
In the FDA's regulations covering electronic signatures,
what does the term Act refer to? - correct answers✅Act
means the Federal Food, Drug and Cosmetic Act.
In the FDA's Electronic Signatures regulation, what does
the term agency refer to? - correct answers✅Agency
refers to the Food and Drug Administration
What is the term that means a method of verifying an
individual's identity based on measurement of the
individual's physical feature(s) or repeatable actions(s)
where those features and/or actions are both measurable
and unique to that individual? - correct
answers✅Biometrics
What does the term closed system mean with regard to
electronic records? - correct answers✅Closed system
means environment in which system access is controlled
by persons who are responsible for the content of the
electronic records that are in the system.
An electronic signature is based upon cryptographic
methods of originator authentication, computed 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. T or F? - correct answers✅False.
, SOCRA Exam Questions And Answers
2024
This is the definition for the term digital signature.
Any combination of text, graphics, data, pictorial, audio,
or other information representation in digital form that is
created, modified, maintained, archived, retrieved, or
distributed by a computer system is known as what? -
correct answers✅Electronic Record.
Electronic signature and digital signature are synonymous
terms. or F? - correct answers✅False.
Electronic signature means a computer data complilatiom
of any symbol or series of symbols executed and
authorized by an individual to be the legally binding
equivalent of the handwritten signature. A digital
signature is based upon cryptographic methods or
originator authentication, a set of computed by using
rules and a set of parameters such that the identity of the
signer and the integrity of the data can be verified.
What type of signature is the scripted name or legal mark
of an individual preserved with a writing or marking
instrument such as a pen or stylus? - correct
answers✅Handwritten signature
