SOCRA Questions

Question 1

A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct?

a. This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm.
b. This subject should undergo all study procedures as outlined in the protocol.
c. This subject only needs to undergo the study procedures that pertain specifically to the subject.
d. This subject can undergo the study procedures whenever it is convenient.

Answer 1

b. This subject should undergo all study procedures as outlined in the protocol.

Question 2

Informed consent documents must contain which of the following?

a. A description of the scientific background for conducting the investigation
b. An explanation of the purpose of the investigation
c. Contact information for the sponsor of the investigational drug/device
d. A description of the investigator’s responsibilities

Answer 2

b. An explanation of the purpose of the investigation

21 CFR 50
50.25 - Elements of informed consent
(a)(1) - A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.

Question 3

With respect to IRB/IEC membership, both the FDA and the ICH require that

a. A majority of the members’ primary area of interest is in a scientific area
b. At least one member holds a Ph.D. degree or equivalent
one member’s primary area of interest is in a nonscientific area
c. At least one member’s primary area of interest is in a nonscientific area
d. A majority of the members are from or have ties to the institution of record

Answer 3

c. At least one member’s primary area of interest is in a nonscientific area

21 CFR 50
Title 21: Food and Drugs
Part 50: Protection of Human Subjects
50.23: Exception from general requirements
(d)(2). This IRB shall review the proposed IND protocol at a convened meeting at which a majority of the members are present including at least one member whose primary concerns are in nonscientific areas and, if feasible, including a majority of the nonaffiliated members.

Question 4

Which of the following is the proper way to make a correction to a CRF?

A. Completely blacken the incorrect entry and then enter the correct information.
B. Back date the corrected entry with the date of the original entry
C. Initial using the initials of the sponsor’s representative who reviewed the change
D. Add the initials of the person making the change, the date of the change, and, if
necessary, a brief explanation of the change

Answer 4

D. Add the initials of the person making the change, the date of the change, and, if
necessary, a brief explanation of the change

E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry
4.9 Records and Reports
Addendum 4.9.3 - Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e., an audit trail should be maintained); this applies to both written and electronic changes or corrections.

Question 5

A purpose of monitoring clinical trials is to verify that:

a. The rights, safety, and well-being of human subjects are protected
b. Investigators receive adequate payment for their participation in the clinical trial
c. The investigator has received annual reports from the sponsor
d. The regulatory agency has received all case history information of subjects enrolled on the clinical trial

Answer 5

a. The rights, safety, and well-being of human subjects are protected

Question 6

An investigator’s brochure is required for sponsor-investigator investigations; thus, a sponsor-investigator should obtain access to an investigator’s brochure when there is a concurrent or otherwise related commercial investigation for which an investigator’s brochure was developed.
a. True
b. False

Answer 6

b. False

21 CFR 312
312.23(a)(5)
312.55

312.55 Informing investigators.
(a) Before the investigation begins, a sponsor (other than a sponsor-investigator) shall give each participating clinical
investigator an investigator brochure containing the information described in §312.23(a)(5).

The question is false because it states, “required for sponsor-investigator investigations.”

Question 7

CBER stands for ________.

a. Center for Biological Evaluation and Research
b. Center for Biologics Evaluation and Research
c. Central for Biological Examination and Research
d. Center for Biologics and Evaluations and Research

Answer 7

b. Center for Biologics Evaluation and Research

Question 8

CDER stands for ______.

Answer 8

Center for Drug Evaluation and Research

Question 9

The CFR is the codification of the general and permanent rules published in the ________by the executive departments and agencies of the Federal government.

a. Federal Registry
b. Federal Regulatory
c. Federal Register
d. Foreign Register

Answer 9

b. Federal Regulatory

Question 10

After a sponsor-investigator determines that an IND needs to be submitted to the FDA, he or she should acquire the relevant information for the IND related to the on-going trial.

a. True
b. False

Answer 10

b. False

The part of the statement that is false is where it says on-going trial. For the statement to be true it would need to say proposed trial.

Question 11

A sponsor-investigator may not be required to submit an IND for a study of a lawfully marketed drug if the criteria for an IND exemption are met.

a. True
b. False

Answer 11

a. True

See 312.2 (b)
The clinical investigation of a drug product that is lawfully marketed in the United States is exempt from the requirements if all exemptions are met.

Question 12

This guidance is intended for sponsor-investigators who are developing a drug for commercial purposes (i.e., seeking market approval or licensure) and thus does not focus on certain regulatory requirements that involve exchange of information or materials between a sponsor and investigator.

a. True
b. False

Answer 12

b. False

The part of the statement that is incorrect is the part where it states “This guidance is intended for sponsor-investigators…
If the statement said “This guidance is not intended for sponsor-investigators…

Question 13

The FDA’s primary objectives in reviewing an IND are to ________.

a. help protect the rights and safety of subjects in phases 1 and 2
b. help protect the rights and safety of subjects in phases 2 and 3
c. help ensure that the quality of the clinical trial is adequate to evaluate the drug’s effectiveness and safety.
d. a and b
e. a and c

Answer 13

e. a and c

21 CFR 312

312.22 - General Principles of the IND Submission

312.22(a) - (a) FDA’s primary objectives in reviewing an IND are, in all phases of the investigation, to assure the safety and rights of subjects, and, in Phase 2 and 3, to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug’s effectiveness and safety. Therefore, although FDA’s review of Phase 1 submissions will focus on assessing the safety of Phase 1 investigations, FDA’s review of Phases 2 and 3 submissions will also include an assessment of the scientific quality of the clinical investigations and the likelihood that the investigations will yield data capable of meeting statutory standards for marketing approval.

The most correct answer is e, even though b is also correct.

Question 14

A/An _______ is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.

a. sponsor-investigator
b. sponsor
c. investigator
d. pharmaceutical company

Answer 14

a. sponsor-investigator
21 CFR 312

312.3 Definitions and interpretations
312.3(b) Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.

Question 15

A sponsor can be a/an _________.

a. individual
b. governmental agency
c. private organization
d. pharmaceutical company
e. all of the above

Answer 15

e. all of the above

21 CFR 312

312.3 Definitions and interpretations
312.3(b)
Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.

Question 16

The _________ is a summary of the chemical, toxicological, and pharmacokinetic aspects of an investigational drug including any information on its safety and efficacy obtained from any prior clinical trials, and a description of any anticipated risks, side effects, precautions, and special monitoring.

a. Clinical Trial Protocol
b. Investigator’s brochure
c. Chemistry, Manufacturing, and Control Information
d. Summary of previous human experience

Answer 16

b. Investigator’s brochure

21 CFR 312
312.23 IND Content and format

312.23(a)(5)(i - v)
Investigator’s brochure (required of sponsors and recommended but not required of sponsor-investigators): A summary of the chemical, toxicological, and pharmacokinetic aspects of an investigational drug including any information on its safety and efficacy obtained from any prior clinical trials, and a description of any anticipated risks, side effects, precautions, and special monitoring.

Question 17

All employees or individuals who are involved in the conduct of an investigation are considered investigators.

a. True
b. False

Answer 17

b. False

Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. “Sub-investigator” includes any other individual member of that team.

Question 18

When the subject provides consent on the same day that he/she begins participation in the clinical investigation, the subject’s case history does not need to document that the subject provided consent prior to participation in the research.

a. True
b. False

Answer 18

b. False

(21 CFR 50.27(a))

(a) Except as provided in § 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form.

Question 19

When appropriate, the consent process must inform the subject of anticipated circumstances under which the investigator may end the subject’s participation without the subject’s consent.

a. True
b. False

Answer 19

a. True

(21 CFR 50.25(b)(2))
(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(2) Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.

Question 20

The FDA recommends that the cost of any _________ that may be charged to the subject, the subject’s insurance, or other reimbursement mechanism be explained as part of the informed consent process.

a. tests
b. products
c. procedures
d. tests, products, and/or procedures

Answer 20

d. tests, products, and/or procedures

(21 CFR 50.25(b)(3)
(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(3) Any additional costs to the subject that may result from participation in the research.

Question 21

According to _________ statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.

a. 21 CFR 50.25(b)(5)
b. 21 CFR 50.25(b)(4)
c. 21 CFR 50.27(a)
d. 21 CFR 56.109(c)

Answer 21

a. 21 CFR 50.25(b)(5)

50.25 Elements of informed consent
(b) Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(5) A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject.

(4) The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.

Question 22

For studies involving no more than minimal risk, and no procedures for which written consent is normally required outside the research context, oral consent from a subject or a subject’s legally authorized representative is permissible under 21 CFR 56.109(c).

a. True
b. False

Answer 22

a. True

21 CFR 56.109(c)

An IRB shall require documentation of informed consent in accordance with §50.27 of this chapter, except as follows:
(1) The IRB may, for some or all subjects, waive the requirement that the subject, or the subject’s legally authorized representative, sign a written consent form if it finds that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.

Question 23

IRBs may consider approving the use of a ________ form in situations where the subject or the subject’s legally authorized representative is unable to read due to illiteracy or blindness.

a. long
b. short

Answer 23

b. short

(2) A short form written consent document stating that the elements of informed consent required by §50.25 have been presented orally to the subject or the subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both
the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

Question 24

Under 21 CFR 50.27, the short form is to be signed by the _________. However, the ________ shall sign both the short form and a copy of the summary, and the _________ actually obtaining the consent shall sign a copy of the summary.
a. subject or the representative/person obtaining the consent/witness
b. subject or the representative/witness/person obtaining the consent
c. person obtaining the consent/witness/subject or the representative

Answer 24

B. subject or the representative
/witness/
person obtaining the consent
21 CFR 50.27(b)(2)

The subject or the subject’s legally authorized representative only signs and dates the short form. (21 CFR 50.27(a) and (b)(2).) The witness must sign both the short form and the summary, and the person obtaining consent must sign the summary. (21 CFR 50.27(b)(2).)

Question 25

The purpose of the _________ on a short form is generally to attest to the voluntariness of the _________ consent and the adequacy of the consent process by ensuring that the information was accurately conveyed and that the _________ questions were answered. a. subject or the representative/subject’s/witness b. subject or the representative/witness’/subject’s c. witness /subject’s/subject’s d. person obtaining consent/witness’/subject’s

Answer 25

c. witness /subject’s/subject’s 21 CFR 50.27(b)(2) The purpose of the witness is generally to attest to the voluntariness of the subject’s consent and the adequacy of the consent process by ensuring that the information was accurately conveyed and that the subject’s questions were answered.

Question 26

When oral consent is used, the FDA does not recommend that documentation of the process (information provided, name of individual obtaining consent, date consent obtained) be included in the study records. a. True b. False

Answer 26

b. False 312.62(b) 812.140(a)(3) The reason the question is false is it says does not recommend Case histories include the case report forms and supporting data including, for example, signed and dated consent forms and medical records including, for example, progress notes of the physician, the individual's hospital chart(s), and the nurses' notes. The case history for each individual shall document that informed consent was obtained prior to participation in the study.

Question 27

The short form embodies all the elements of informed consent as required under 21 CFR 50.25. a. True b. False

Answer 27

b. False 21 CFR 50.25(b)(1) The question should read: A written consent document This form may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.

Question 28

The FDA believes that all of the following AEs should be considered as unanticipated problems that must be reported to the IRB except for _________. a. A single occurrence of a serious, unexpected event that is uncommon and strongly associated with drug exposure. b. A single occurrence, or more often a small number of occurrences, of a serious, unexpected event that is not commonly associated with drug exposure, but uncommon in the study population. c. Multiple occurrences of an AE that, based on an aggregate analysis, is determined to be an unanticipated problem. d. An AE that is described or addressed in the investigator’s brochure, protocol, or informed consent documents, but occurs at a specificity or severity that is consistent with prior observations.

Answer 28

d. An AE that is described or addressed in the investigator’s brochure, protocol, or informed consent documents, but occurs at a specificity or severity that is consistent with prior observations. The reason the answer is d because it says consistent with prior observations.

Question 29

FDA regulations use the following different terms when referring to an adverse event: a. adverse experience b. adverse effect c. unanticipated problems d. all of the above

Answer 29

d. all of the above a. adverse experience - 312.33, 312.44 312.53 b. adverse effect - 312.50, 312.55, 312.310, 812.3, 812.5, 812.38 c. unanticipated problems - 46.108, 56.108, 312.53,

Question 30

The secondary purpose of both the initial and continuing review of the study is “to assure the protections of the rights and welfare of the human subjects”. a. True b. False

Answer 30

b. False The question is false because it says "secondary purpose" 56.102(g)) - The primary purpose of both initial and continuing review of the study is “to assure the protection of the rights and welfare of the human subjects” (§ 56.102(g)).

Question 31

Investigators are required to report promptly to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. a. True b. False

Answer 31

a. True 312.64(b) - An investigator must immediately report to the sponsor any serious adverse event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there is a reasonable possibility that the drug caused the event.

Question 32

In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were _________. a. expected b. serious c. would have implications for the conduct of the study d. b. and c. e. a.,b.,and c.

Answer 32

d. b. and c. If a. was unexpected it would be e. 312.32(a)

Question 33

The regulations state that for studies conducted under 21 CFR part 312, investigators must report all "unanticipated problems" to the IRB according to §§ __________. a. 312.66 b. 312.53(c)(1)(vii) c. 56.108(b)(1) d. all of the above

Answer 33

d. all of the above The regulations state that for studies conducted under 21 CFR part 312, investigators must report all "unanticipated problems" to the IRB (312.66, 312.53(c)(1)(vii), and 56.108(b)(1)). 312.66 -The investigator shall also assure that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects 312.53(c)(1)(vii) - A commitment by the investigator that, for an investigation subject to an institutional review requirement under part 56, an IRB that complies with the requirements of that part will be responsible for the initial and continuing review and approval of the clinical investigation and that the investigator will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects or others, 56.108(b)(1) - Follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Food and Drug Administration of: (1) Any unanticipated problems involving risks to human subjects or others;

Question 34

For device studies, investigators are required to submit a report of a UADE to the sponsor and the reviewing IRB as soon as possible, but in no event later than _________ after the investigator first learns of the event. a. 10 working days b. 10 days c. 5 working days d. 5 days

Answer 34

a. 10 working days 812.50(a)(1) - Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect. 812.50(b)(1) - Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated adverse device effect under 812.46(b) shall report the results of such evaluation to FDA and to all reviewing IRB's and participating investigators within 10 working days after the sponsor first receives notice of the effect.

Question 35

UADE stands for _________. a. unanticipated adverse drug effect b. unanticipated adverse device effect c. unanticipated adverse device experience d. unwarranted adverse device effect e. unwarranted adverse device effect

Answer 35

b. unanticipated adverse device effect 812.3(s) Unanticipated adverse device effect means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Question 36

An AE that is described or addressed in the investigator’s brochure, protocol, or informed consent documents, but occurs at a specificity or severity that is inconsistent with prior observations is considered as an unanticipated problem. a. True b. False

Answer 36

a. True 312.32 Unexpected adverse event or unexpected suspected adverse reaction. An adverse event or suspected adverse reaction is considered “unexpected” if it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if the investigator brochure referred only to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the investigator brochure listed only cerebral vascular accidents. “Unexpected,” as used in this definition, also refers to adverse events or suspected adverse reactions that are mentioned in the investigator brochure as occurring with a class of drugs or as anticipated from the pharmacological properties of the drug, but are not specifically mentioned as occurring with the particular drug under investigation.

Question 37

In a multicenter study, the ________ is in a better position to process and analyze the significance of AE information from multiple sites. a. investigator b. IRB c. FDA d. sponsor

Answer 37

d. sponsor

Question 38

In 21CFR 11 - What are open systems?

Answer 38

An open system refers to an environment where individuals responsible for the content of electronic records on the system do not control system access, according to 21 CFR 11.3(b)(9).

Question 39

In 21CFR 11 - Examples of open systems?

Answer 39

Email, cloud services

Question 40

In 21CFR 11 - What are closed systems?

Answer 40

A closed system, as defined by 21 CFR 11.3(b)(4), is an environment where system access is controlled by persons responsible for the content of electronic records stored in the system.

Question 41

In 21CFR 11 - Examples of closed systems?

Answer 41

Examples of closed systems include: Document Management Systems (DMS) (SAI360) Quality Management System (QMS) Clinical trial management systems (CTMS) (OnCore) Regulatory information management System (RIMS) for managing regulatory submissions (Florence)