SOCRA Questions from Journals

Question 1

CBER stands for:

Answer 1

Center for Biologics Evaluation and Research

Question 2

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

Answer 2

Federal Register

Question 3

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. (T/F)

Answer 3

False

Question 4

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. (T/F)

Answer 4

True

Question 5

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

Answer 5

1. Help protect the rights and safety of subjects in phases 1 and 2.
2. Help ensure that the quality of the clinical trial is adequate to evaluate the drug’s effectiveness and safety

Question 6

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

Answer 6

sponsor-investigator

Question 7

A sponsor can be a/an _________.

Answer 7

An individual, governmental agency, private organization, and pharmaceutical company

Question 8

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.

Answer 8

Investigator’s brochure

Question 9

All employees or individuals who are involved in the conduct of an investigation are considered investigators. (T/F)

Answer 9

False

Question 10

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. (T/F)

Answer 10

False

Question 11

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. (T/F)

Answer 11

True

Question 12

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.

Answer 12

tests, products, and/or procedures

Question 13

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.

Answer 13

21 CFR 50.25(b)(5)

Question 14

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). (T/F)

Answer 14

True

Question 15

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.

Answer 15

Short

Question 16

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.

Answer 16

subject or the representative
witness
person obtaining the consent

Question 17

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.

Answer 17

witness
subject’s
subject’s

Question 18

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. (T/F)

Answer 18

False

Question 19

The short form embodies all the elements of informed consent as required under 21 CFR 50.25. (T/F)

Answer 19

False

Question 20

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 20

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.

Question 20

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 20

d. all of the above

Question 21

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.” (T/F)

Answer 21

False

Question 22

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. (T/F)

Answer 22

True

Question 23

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 23

d. b. and c.

Question 24

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 24

d. all of the above

Question 25

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 25

a. 10 working days

Question 26

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

Answer 26

b. unanticipated adverse device effect

Question 27

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 27

a. True

Question 28

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 28

d. sponsor

Question 29

The FDA regulations at 21 CFR 812.3(t) define an IEC as “a dependent review panel that is responsible for ensuring the protection of the rights, safety, and well-being of subjects involved in a clinical investigation and is adequately constituted to ensure that protection.” (T/F)

Answer 29

false The answer is false because it says "a dependent review panel"

Question 30

The sponsor or applicant may follow _________ or ICH E6, by providing a sample or model informed consent form that describes any incentives provided to subjects to participate in the investigation, to satisfy 21 CFR 812.28(b)(10). a. ISO 14155:2012 b. ISO 14155:2010 c. ISO 14156:2011 d. ISO 14155:2011

Answer 30

d. ISO 14155:2011

Question 31

The description of actions that the sponsor or applicant took to ensure the research conformed with GCP must provide either the information under 21 CFR 812.28(e), as specified in 21 CFR 812.28(b)(3), or a cross-reference to another section of the application or submission where the information is located. a. true b. false

Answer 31

b. false

Question 32

A description of how informed consent was obtained should address ________. a. who obtained b. when the consent was obtained c. conditions under which the consent was obtained d. where the consent took place e. all of the above f. a., b. and c.

Answer 32

f. a., b. and c.

Question 33

Although continuing review is required by the IEC, the sponsor or applicant is not required to be submitted to the _________. a. FDA b. OSU c. GCP d. all of the above

Answer 33

a. FDA

Question 34

Under _________ sponsors or applicants must submit a statement indicating whether written commitments by investigators to comply with GCP and the protocol were obtained and, if so, to maintain such commitments on file to be provided upon the Agency’s request. a. 21 CFR 812.29(b)(12) b. 21 CFR 812.28(b)(12) c. 21 CFR 812.28(a)(12) d. 21 CFR 821.28(b)(12)

Answer 34

b. 21 CFR 812.28(b)(12) A description of how investigators were trained to comply with GCP (as described in paragraph (a)(1) of this section) and to conduct the investigation in accordance with the protocol, and a statement on whether written commitments by investigators to comply with GCP and the protocol were obtained. Any signed written commitments by investigators must be maintained by the sponsor or applicant and made available for agency review upon request.

Question 35

If the detailed description of the device required under _________ is already included in other sections of the IDE or device marketing application or submission, this requirement can be met by cross-referencing those other sections of the application or submission. a. 21 CFR 812.28(b)(5) b. 21 CFR 812.28(a)(5) c. 21 CFR 813.38(b)(5) d. 21 CFR 812.28(b)(6)

Answer 35

a. 21 CFR 812.28(b)(5) (5) Either a statement that the device used in the investigation conducted outside the United States is identical to the device that is the subject of the submission or application, or a detailed description of the device and each important component (including all materials and specifications), ingredient, property, and principle of operation of the device used in the investigation conducted outside the United States and a comparison to the device that is the subject of the submission or application that indicates how the device used in the investigation is similar to and/or different from the device that is the subject of the submission or application;

Question 36

If the records exist but a sponsor or applicant cannot disclose them to the FDA because such disclosure is prohibited by applicable foreign law, the sponsor or applicant may seek a waiver of this requirement. a. true b. false

Answer 36

b. false

Question 37

The FDA recommends that every nondiscriminatory effort be made to ensure that the IEC composition is not limited to only one _________. a. cultural diversity b. age group c. gender d. socio-economic group

Answer 37

c. gender

Question 38

The use of the word(s) _______ in joint OHRP and FDA guidance means that something is required under the HHS regulations at 45 CFR part 46 or the FDA regulations at 21 CFR parts 50 and 56. a. should b. must c. highly recommended d. if applicable

Answer 38

b. must

Question 39

_________ is not an example of noncompliance related to minutes. a. The minutes are missing. b. The voting outcome was expressed as passed unanimously c. The minutes reflect an inaccurate account of the meeting attendance d. The minutes included the number of members voting for, against, and abstaining

Answer 39

d. The minutes included the number of members voting for, against, and abstaining.

Question 40

IRBs must comply with HHS and FDA regulations in 45 CFR part 46 and 21 CFR __________, respectively, when reviewing research subject to those regulations. a. parts 52 and 56 b. parts 50 and 55 c. parts 51 and 56 d. parts 50 and 56

Answer 40

d. parts 50 and 56

Question 41

The minutes do not need to clarify which members, if any, participated in the convened meeting via an alternative mechanism, such as telephone or video conferencing. a. true b. false

Answer 41

b. false

Question 42

The use of the word(s) _______ in joint OHRP and FDA guidance means that something is recommended or suggested, but not required. a. must b. should c. highly recommended d. if applicable

Answer 42

b. should

Question 43

The IRB must review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in _________. a. nonscientific areas b. scientific areas c. medical ethics d. clerical areas

Answer 43

a. nonscientific areas

Question 44

A quorum is the maximum number and type of IRB members that must be present at a convened meeting. a. true b. false

Answer 44

b. false

Question 45

When an alternate member substitutes for a primary member due to a conflicting interest, the minutes should_________. a. identify the name of the primary member for who the alternate member is substituting for b. state the reason for the substitution c. both of the above

Answer 45

c. both of the above

Question 46

IRBs often calculate majority by using the “half-plus-one” technique. If the total IRB membership is 12, then the majority is ________. a. 14 b. 6 c. 7 d. 8

Answer 46

c. 7

Question 47

10. A quorum _______ be maintained throughout the meeting. If quorum is lost during a meeting, then the IRB _________ vote on proposed research. a. should/may b. must/may c. must/may not d. should/may not

Answer 47

c. must/may not

Question 48

Each IRB that uses an expedited review procedure must adopt a method for keeping all members advised of research proposals which have been approved under the expedited review procedure _________. a. 45 CFR 46.110 21 CFR 56.110(c) b. 45 CFR 46.110(c); 21 CFR 56.110 c. 45 CFR 46.110(c); 21 CFR 56.110(c) d. 45 CFR 46.110(b); 21 CFR 56.110(c)

Answer 48

c. 45 CFR 46.110(c) - (c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure. 21 CFR 56.110(c) - Part 56 - IRBs Part C - IRB Functions and Operations 110 - Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. (c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure.

Question 49

45 CFR 46 Subpart C

Answer 49

Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

Question 50

Research conducted under 45 CFR 46 subpart B involves __________. a. human fetuses b. neonates c. pregnant women d. all of the above

Answer 50

d. all of the above

Question 51

NSR stand for __________. a. nonsignificant risk b. no standard risk c. never seen risk d. non-serious risk

Answer 51

a. nonsignificant risk

Question 52

LAR stands for _________. a. lawful approved representative b. legally approved representative c. legally authorized representative d. lawfully authorized representative

Answer 52

c. legally authorized representative

Question 53

Any decision to suspend or terminate the study that occurs outside of a convened IRB meeting does not need to be reported to the convened IRB and the discussion summarized in the minutes. a. true b. false

Answer 53

b. false

Question 54

The ________ interpret “actions taken by the IRB” to refer to any vote taken by the IRB related to a proposed research activity. a. OHRP and CFR b. OHRP and ICH c. OHRP d. OHRP and FDA

Answer 54

d. OHRP and FDA

Question 55

When an IRB approves a waiver or alteration of consent for research reviewed by the convened IRB, these findings must be documented _________. a. 45 CFR 46.116(c) and (d) b. 45 CFR 46.116(a) and (d) c. 45 CFR 46.116(b) and (c) d. 45 CFR 46.116(c) and (f)

Answer 55

a.45 CFR 46.116(c) and (d) 45 CFR 46 Subpart A—Basic HHS Policy for Protection of Human Research Subjects 46.116 - General requirements for informed consent. In addition, for HHS - conducted or - supported research, the regulations at 45 CFR 46.116(c) and (d) permit an IRB to approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent provided the IRB finds and documents that certain criteria are met

Question 56

Each IRB that reviews studies involving children as subjects is covered by __________. a. 45 CFR 46 subpart A, and 21 CFR 50 Subpart A b. 45 CFR 46 subpart B, and 21 CFR 50 Subpart B c. 45 CFR 46 subpart C, and 21 CFR 50 Subpart C d. 45 CFR 46 subpart D, and 21 CFR 50 Subpart D

Answer 56

d. 45 CFR 46 subpart D, and 21 CFR 50 Subpart D

Question 57

The IRB must also determine that requirements for permission by parents or guardians and for assent by children are met (45 CFR 46.408; 21 CFR 50.55). a. true b. false

Answer 57

a. true