SoCRA CERTIFICATION EXAM AND PRACTICE EXAM ACTUAL
EXAMS QUESTIONS AND CORRECT DETAILED ANSWERS WITH
RATIONALES
Question 1
Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten
paper signatures?
A) No, they are considered less reliable.
B) Yes (although permission to use such e-sigs has to be approved by the FDA).
C) Only if they are encrypted.
D) Only for non-critical documents.
E) Only in a closed system.
Correct Answer: B) Yes (although permission to use such e-sigs has to be approved
by the FDA)
Rationale: The FDA's 21 CFR Part 11 allows for the use of electronic signatures,
provided specific regulatory requirements for trustworthiness, reliability, and
equivalence to paper records are met and approved by the FDA.
Question 2
Does the FDA consider electronic records that meet regulatory requirements to be equivalent
to handwritten records?
A) No, electronic records are always secondary.
B) Yes.
C) Only for internal audits.
D) Only if they are printed out.
E) Only if the system is open.
Correct Answer: B) Yes
,Rationale: FDA regulations (21 CFR Part 11) establish that electronic records can be
considered equivalent to paper records, provided they meet specific technical and
procedural requirements ensuring their integrity and authenticity.
Question 3
What does the FDA define as an "Open System" for electronic records?
A) A system with public access.
B) A system where access is controlled by the same people responsible for the content.
C) A system where access is NOT controlled by people who are responsible for the content of
the electronic records in the system.
D) A system that is not password-protected.
E) A system that allows all users to modify records.
Correct Answer: C) System access is NOT controlled by people who are responsible
for the content of the electronic records in the system. (Like me putting data into
CHOP - controlled databases)
Rationale: An open system implies that the environment where the electronic
records are created, maintained, or stored is not entirely under the control of the
organization responsible for the content, often involving network access by
external parties.
Question 4
What does the FDA define as a "Closed System" for electronic records?
A) A system with restricted public access.
B) A system where access is NOT controlled by the people responsible for the content.
C) An environment in which system access is controlled by the same people responsible for the
,content of the system.
D) A system that requires manual data entry.
E) A system that is offline.
Correct Answer: C) Environment in which SYSTEM ACCESS is controlled by the
same people responsible for the content of the system (I.E. I control the Robotic
Database access AND its contents)
Rationale: In a closed system, the security of the electronic record-keeping
environment is entirely under the control of the individuals or organization
responsible for the content of those records.
Question 5
Which of the following is NOT an FDA standard to meet when operating a closed record
system?
A) Must be able to tell if records have been altered or invalid.
B) Protect records throughout the retention period.
C) Limit system to authorized individuals only.
D) Document encryption as appropriate.
E) Use time-stamped audit trails of modification.
Correct Answer: D) Document encryption as appropriate
Rationale: Encryption is a specific additional requirement for open systems, where
data transmission over uncontrolled networks needs protection. All other options
are core requirements for ensuring integrity and security in a closed system.
Question 6
Which of the following is a specific FDA standard for operating an Open System for electronic
, records, in addition to all requirements for a closed system?
A) Limit system to authorized individuals only.
B) Use time-stamped audit trails of modification.
C) Document encryption as appropriate.
D) Protect records throughout the retention period.
E) Use operational system checks and restrictions.
Correct Answer: C) Document encryption as appropriate
Rationale: For open systems, where records may be transmitted over networks not
entirely controlled by the responsible parties, encryption is explicitly required to
protect the confidentiality and integrity of the data.
Question 7
What information should a handwritten signature block contain?
A) Only the printed name of the signer.
B) Only the date and time of execution.
C) Printed name of signer, Date and Time when signature was executed, The meaning
associated with the signature.
D) Only the meaning of the signature.
E) The signer's address and phone number.
Correct Answer: C) 1. Printed name of signer 2. Date and Time when signature was
executed 3. The MEANING associated with the signature (approval? responsibility?
authorship?)
Rationale: These three components are essential for ensuring that a handwritten
signature in a regulated context is clear, auditable, and conveys its specific intent.
EXAMS QUESTIONS AND CORRECT DETAILED ANSWERS WITH
RATIONALES
Question 1
Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten
paper signatures?
A) No, they are considered less reliable.
B) Yes (although permission to use such e-sigs has to be approved by the FDA).
C) Only if they are encrypted.
D) Only for non-critical documents.
E) Only in a closed system.
Correct Answer: B) Yes (although permission to use such e-sigs has to be approved
by the FDA)
Rationale: The FDA's 21 CFR Part 11 allows for the use of electronic signatures,
provided specific regulatory requirements for trustworthiness, reliability, and
equivalence to paper records are met and approved by the FDA.
Question 2
Does the FDA consider electronic records that meet regulatory requirements to be equivalent
to handwritten records?
A) No, electronic records are always secondary.
B) Yes.
C) Only for internal audits.
D) Only if they are printed out.
E) Only if the system is open.
Correct Answer: B) Yes
,Rationale: FDA regulations (21 CFR Part 11) establish that electronic records can be
considered equivalent to paper records, provided they meet specific technical and
procedural requirements ensuring their integrity and authenticity.
Question 3
What does the FDA define as an "Open System" for electronic records?
A) A system with public access.
B) A system where access is controlled by the same people responsible for the content.
C) A system where access is NOT controlled by people who are responsible for the content of
the electronic records in the system.
D) A system that is not password-protected.
E) A system that allows all users to modify records.
Correct Answer: C) System access is NOT controlled by people who are responsible
for the content of the electronic records in the system. (Like me putting data into
CHOP - controlled databases)
Rationale: An open system implies that the environment where the electronic
records are created, maintained, or stored is not entirely under the control of the
organization responsible for the content, often involving network access by
external parties.
Question 4
What does the FDA define as a "Closed System" for electronic records?
A) A system with restricted public access.
B) A system where access is NOT controlled by the people responsible for the content.
C) An environment in which system access is controlled by the same people responsible for the
,content of the system.
D) A system that requires manual data entry.
E) A system that is offline.
Correct Answer: C) Environment in which SYSTEM ACCESS is controlled by the
same people responsible for the content of the system (I.E. I control the Robotic
Database access AND its contents)
Rationale: In a closed system, the security of the electronic record-keeping
environment is entirely under the control of the individuals or organization
responsible for the content of those records.
Question 5
Which of the following is NOT an FDA standard to meet when operating a closed record
system?
A) Must be able to tell if records have been altered or invalid.
B) Protect records throughout the retention period.
C) Limit system to authorized individuals only.
D) Document encryption as appropriate.
E) Use time-stamped audit trails of modification.
Correct Answer: D) Document encryption as appropriate
Rationale: Encryption is a specific additional requirement for open systems, where
data transmission over uncontrolled networks needs protection. All other options
are core requirements for ensuring integrity and security in a closed system.
Question 6
Which of the following is a specific FDA standard for operating an Open System for electronic
, records, in addition to all requirements for a closed system?
A) Limit system to authorized individuals only.
B) Use time-stamped audit trails of modification.
C) Document encryption as appropriate.
D) Protect records throughout the retention period.
E) Use operational system checks and restrictions.
Correct Answer: C) Document encryption as appropriate
Rationale: For open systems, where records may be transmitted over networks not
entirely controlled by the responsible parties, encryption is explicitly required to
protect the confidentiality and integrity of the data.
Question 7
What information should a handwritten signature block contain?
A) Only the printed name of the signer.
B) Only the date and time of execution.
C) Printed name of signer, Date and Time when signature was executed, The meaning
associated with the signature.
D) Only the meaning of the signature.
E) The signer's address and phone number.
Correct Answer: C) 1. Printed name of signer 2. Date and Time when signature was
executed 3. The MEANING associated with the signature (approval? responsibility?
authorship?)
Rationale: These three components are essential for ensuring that a handwritten
signature in a regulated context is clear, auditable, and conveys its specific intent.
