SOCRA CERTIFICATION EXAM QUESTIONS AND ANSWERS 100%
VERIFIED | LATEST UPDATE 2025
Question 1
According to 21 CFR Part 11, a method of verifying an individual's identity based on the
measurement of unique physical features or repeatable actions is known as:
A) A digital signature
B) An electronic signature
C) A handwritten signature
D) Biometrics
E) An open system
Correct Answer: D) Biometrics
Rationale: Biometrics, as defined in 21 CFR 11.3, is a specific method of authentication that
relies on a person's unique physical characteristics (like a fingerprint or iris scan) or
measurable actions.
Question 2
What is the term for a computer system environment in which access is controlled by the persons
who are responsible for the content of the electronic records on that system?
A) An open system
B) A closed system
C) A digital system
D) A cryptographic system
E) A validated system
Correct Answer: B) A closed system
Rationale: A closed system, as defined in 21 CFR 11.3, is an environment where the
organization that is responsible for the record content also controls access to the system,
which simplifies some of the security controls.
Question 3
An electronic signature that is based upon cryptographic methods, allowing for the verification
of the signer's identity and the integrity of the data, is known as a(n):
A) Electronic signature
B) Biometric signature
,[Type here]
C) Digital signature
D) Handwritten signature
E) Authenticated signature
Correct Answer: C) Digital signature
Rationale: A digital signature, as defined in 21 CFR 11.3, is a specific type of electronic
signature that uses a cryptographic, public-key infrastructure to provide a high level of
security, authentication, and non-repudiation.
Question 4
Under 21 CFR Part 11, any combination of text, graphics, data, or other information represented
in digital form that is managed by a computer system is defined as a(n):
A) Audit trail
B) Case Report Form (CRF)
C) Electronic record
D) Source document
E) Digital signature
Correct Answer: C) Electronic record
Rationale: This is the broad definition of an electronic record provided in 21 CFR 11.3. It
encompasses any information in a digital format that is created, modified, maintained, or
distributed by a computer system subject to FDA regulations.
Question 5
In a clinical research context, who is the individual that actually conducts the clinical
investigation and under whose immediate direction the test article is administered to a subject?
A) The Sponsor
B) The Monitor
C) The Investigator
D) The Contract Research Organization (CRO)
E) The Legally Authorized Representative
Correct Answer: C) The Investigator
Rationale: As defined in 21 CFR 50.3, the Investigator is the individual who is hands-on
,[Type here]
with the conduct of the trial and is directly responsible for the administration of the
investigational product to the human subjects.
Question 6
A pharmaceutical company initiates a clinical trial for a new drug but hires a team of physicians
at a university to conduct the study. In this scenario, the pharmaceutical company is the:
A) Investigator
B) Sponsor
C) Sponsor-Investigator
D) Contract Research Organization (CRO)
E) Institution
Correct Answer: B) Sponsor
Rationale: According to 21 CFR 50.3, the Sponsor is the entity that initiates the clinical
investigation but does not actually conduct it. They take responsibility for and initiate the
study.
Question 7
An individual physician who both initiates and personally conducts a clinical investigation of a
new device is known as a(n):
A) Sponsor
B) Investigator
C) Sponsor-Investigator
D) Monitor
E) Legally Authorized Representative
Correct Answer: C) Sponsor-Investigator
Rationale: A Sponsor-Investigator, as defined in 21 CFR 50.3, is a single individual who
takes on the responsibilities of both the sponsor (initiating the trial) and the investigator
(conducting the trial). This term does not apply to corporations or agencies.
Question 8
What is the definition of a "human subject" according to 21 CFR 50.3?
A) Only a healthy volunteer who participates in research.
, [Type here]
B) Only a patient who receives a test article.
C) An individual who is or becomes a participant in research, either as a recipient of the test
article or as a control.
D) A living individual about whom an investigator obtains identifiable private information.
E) Any person who provides a tissue sample for research.
Correct Answer: C) An individual who is or becomes a participant in research, either as a
recipient of the test article or as a control.
Rationale: This is the specific FDA definition under 21 CFR 50.3. It clearly includes
individuals in both the treatment and control arms of a clinical investigation.
Question 9
A formally designated group within an institution that is responsible for reviewing and approving
biomedical research involving human subjects is known as a(n):
A) Independent Ethics Committee (IEC)
B) Institutional Review Board (IRB)
C) Data Monitoring Committee (DMC)
D) Coordinating Committee
E) Sponsor
Correct Answer: B) Institutional Review Board (IRB)
Rationale: The IRB, as defined in 21 CFR 50.3, is the formally constituted committee at an
institution that has the authority and responsibility to review, approve, and provide
oversight for research involving human subjects to ensure their protection.
Question 10
The term "minimal risk" means that the probability and magnitude of harm or discomfort
anticipated in the research are not greater than those ordinarily encountered in:
A) High-risk surgical procedures.
B) Daily life or during routine physical or psychological examinations.
C) Any previous clinical trials.
D) Situations involving a life-threatening illness.
E) The hospital environment.
VERIFIED | LATEST UPDATE 2025
Question 1
According to 21 CFR Part 11, a method of verifying an individual's identity based on the
measurement of unique physical features or repeatable actions is known as:
A) A digital signature
B) An electronic signature
C) A handwritten signature
D) Biometrics
E) An open system
Correct Answer: D) Biometrics
Rationale: Biometrics, as defined in 21 CFR 11.3, is a specific method of authentication that
relies on a person's unique physical characteristics (like a fingerprint or iris scan) or
measurable actions.
Question 2
What is the term for a computer system environment in which access is controlled by the persons
who are responsible for the content of the electronic records on that system?
A) An open system
B) A closed system
C) A digital system
D) A cryptographic system
E) A validated system
Correct Answer: B) A closed system
Rationale: A closed system, as defined in 21 CFR 11.3, is an environment where the
organization that is responsible for the record content also controls access to the system,
which simplifies some of the security controls.
Question 3
An electronic signature that is based upon cryptographic methods, allowing for the verification
of the signer's identity and the integrity of the data, is known as a(n):
A) Electronic signature
B) Biometric signature
,[Type here]
C) Digital signature
D) Handwritten signature
E) Authenticated signature
Correct Answer: C) Digital signature
Rationale: A digital signature, as defined in 21 CFR 11.3, is a specific type of electronic
signature that uses a cryptographic, public-key infrastructure to provide a high level of
security, authentication, and non-repudiation.
Question 4
Under 21 CFR Part 11, any combination of text, graphics, data, or other information represented
in digital form that is managed by a computer system is defined as a(n):
A) Audit trail
B) Case Report Form (CRF)
C) Electronic record
D) Source document
E) Digital signature
Correct Answer: C) Electronic record
Rationale: This is the broad definition of an electronic record provided in 21 CFR 11.3. It
encompasses any information in a digital format that is created, modified, maintained, or
distributed by a computer system subject to FDA regulations.
Question 5
In a clinical research context, who is the individual that actually conducts the clinical
investigation and under whose immediate direction the test article is administered to a subject?
A) The Sponsor
B) The Monitor
C) The Investigator
D) The Contract Research Organization (CRO)
E) The Legally Authorized Representative
Correct Answer: C) The Investigator
Rationale: As defined in 21 CFR 50.3, the Investigator is the individual who is hands-on
,[Type here]
with the conduct of the trial and is directly responsible for the administration of the
investigational product to the human subjects.
Question 6
A pharmaceutical company initiates a clinical trial for a new drug but hires a team of physicians
at a university to conduct the study. In this scenario, the pharmaceutical company is the:
A) Investigator
B) Sponsor
C) Sponsor-Investigator
D) Contract Research Organization (CRO)
E) Institution
Correct Answer: B) Sponsor
Rationale: According to 21 CFR 50.3, the Sponsor is the entity that initiates the clinical
investigation but does not actually conduct it. They take responsibility for and initiate the
study.
Question 7
An individual physician who both initiates and personally conducts a clinical investigation of a
new device is known as a(n):
A) Sponsor
B) Investigator
C) Sponsor-Investigator
D) Monitor
E) Legally Authorized Representative
Correct Answer: C) Sponsor-Investigator
Rationale: A Sponsor-Investigator, as defined in 21 CFR 50.3, is a single individual who
takes on the responsibilities of both the sponsor (initiating the trial) and the investigator
(conducting the trial). This term does not apply to corporations or agencies.
Question 8
What is the definition of a "human subject" according to 21 CFR 50.3?
A) Only a healthy volunteer who participates in research.
, [Type here]
B) Only a patient who receives a test article.
C) An individual who is or becomes a participant in research, either as a recipient of the test
article or as a control.
D) A living individual about whom an investigator obtains identifiable private information.
E) Any person who provides a tissue sample for research.
Correct Answer: C) An individual who is or becomes a participant in research, either as a
recipient of the test article or as a control.
Rationale: This is the specific FDA definition under 21 CFR 50.3. It clearly includes
individuals in both the treatment and control arms of a clinical investigation.
Question 9
A formally designated group within an institution that is responsible for reviewing and approving
biomedical research involving human subjects is known as a(n):
A) Independent Ethics Committee (IEC)
B) Institutional Review Board (IRB)
C) Data Monitoring Committee (DMC)
D) Coordinating Committee
E) Sponsor
Correct Answer: B) Institutional Review Board (IRB)
Rationale: The IRB, as defined in 21 CFR 50.3, is the formally constituted committee at an
institution that has the authority and responsibility to review, approve, and provide
oversight for research involving human subjects to ensure their protection.
Question 10
The term "minimal risk" means that the probability and magnitude of harm or discomfort
anticipated in the research are not greater than those ordinarily encountered in:
A) High-risk surgical procedures.
B) Daily life or during routine physical or psychological examinations.
C) Any previous clinical trials.
D) Situations involving a life-threatening illness.
E) The hospital environment.
