SOCRA Continuing Competence Learning Module v16

Question 1

CFR

Answer 1

United States Code of Federal Regulations (US FDA regulations)

Question 2

DSMB

Answer 2

Data Safety Monitoring Board

Question 3

GCP

Answer 3

Good Clinical Practice

Question 4

ICH

Answer 4

International Conference on Harmonisation

Question 5

IDE

Answer 5

Investigational Device Exemption

Question 6

IRB/IEC

Answer 6

Institutional Review Board/Independent Ethics Committee

Question 7

NIH

Answer 7

National Institutes of Health

Question 8

NSR

Answer 8

Non-Significant Risk

Question 9

OHRP

Answer 9

Office for Human Research Protections

Question 10

The Declaration of Helsinki’s recent update (2013) includes each of the following changes, EXCEPT:

a) Changes that provide for increased protection for vulnerable groups involved in research
b) A new provision for compensating people harmed as a result of participating in research
c) Expanded requirements for post-study arrangements to ensure that participants involved in research are informed of the results and have access to any beneficial treatments that emerge
d) A new statement that medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

Answer 10

d) A new statement that medical research involving human subjects may only be conducted if the importance of the objective outweighs the risks and burdens to the research subjects.

This was #21 in the 2008 version.

Question 11

The Declaration of Helsinki’s recent update (2013) in the section on Research Registration and Publication and Dissemination of Results, states each of the following, EXCEPT:

a) Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports
b) All parties should adhere to accepted guidelines for ethical reporting
c) Positive results must be published or otherwise made publicly available while negative and inconclusive results do not need to be published
d) Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication

Answer 11

c) Positive results must be published or otherwise made publicly available while negative and inconclusive results do not need to be published

Question 12

The Declaration of Helsinki’s recent update (2013) states that the responsibility for the protection of the research subject who has given informed consent rests with each of the following, EXCEPT:

a) The physician involved in the medical research
b) The research team members
c) Other healthcare professionals
d) The research subject

Answer 12

d) The research subject

Question 13

The Declaration of Helsinki’s recent update (2013) states that researchers, research protocols, and research ethics committees must adhere to all of the following stipulations, EXCEPT:

a) The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins
b) The ethics committee must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards and thereby, to be sensitive to such norms, may reduce or eliminate selected protections for research subjects set forth in the Declaration of Helsinki
c) The researcher must provide monitoring information to the research ethics committee, especially information about any serious adverse events
d) The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects, and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.

Answer 13

b) The ethics committee must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards and thereby, to be sensitive to such norms, may reduce or eliminate selected protections for research subjects set forth in the Declaration of Helsinki

DoH 10. Physicians must consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

Question 14

Pursuant to the Declaration of Helsinki (2013), each of the following statements regarding informed consent is correct, EXCEPT:

a) Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary
b) In situations where the potential subject is in a dependent relationship with the physician or may consent under duress, the informed consent must be sought be an appropriately qualified individual who is completely independent of the relationship
c) In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions, and any other relevant aspects of the study
d) For a potential research subject who is incapable of giving informed consent, the physician may consent on behalf of the potential research subject. These individuals may be included in a research study that has no likelihood of benefit for them or the group they represent.

Answer 14

d) For a potential research subject who is incapable of giving informed consent, the physician may consent on behalf of the potential research subject. These individuals may be included in a research study that has no likelihood of benefit for them or the group they represent.

DoH 28. For a potential research subject who is incapable of giving informed consent, the physician must seek informed consent from the legally authorised representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

Question 15

In accordance with the ICH/GCP what is the correct reporting timeframe for Final Reports?

a) Annually, or more frequently if requested
b) According to the protocol
c) Completion of study
d) Within 1 year after completion of study

Answer 15

c) Completion of study

4.13 Final Report(s) by Investigator:
Upon completion of the trial, the investigator, where applicable, should inform the institution; the investigator/institution should provide the IRB/IEC with a summary of the trial’s outcome, and the regulatory authority(ies) with any reports required.

Question 16

In accordance with the ICH/GCP what is the correct reporting timeframe for Progress Reports?

a) Annually, or more frequently if requested
b) According to the protocol
c) Completion of study
d) Within 1 year after completion of study

Answer 16

a) Annually, or more frequently if requested

4.10 Progress Reports
4.10.1 The investigator should submit written summaries of the trial status to the IRB/IEC
annually, or more frequently, if requested by the IRB/IEC.

Question 17

In accordance with the ICH/GCP what is the correct reporting timeframe for an adverse event and/or laboratory abnormality?

a) Within 5 days
b) Within 7 days
c) Within 30 days
d) According to the protocol

Answer 17

d) According to the protocol

4. 11.2

Question 18

In accordance with the ICH/GCP what is the correct reporting timeframe for unexpected serious adverse events (SAEs)?

a) Immediately to the Sponsor
b) Within 5 days
c) Within 7 days
d) According to the protocol

Answer 18

a) Immediately to the Sponsor

4. 11.1

Question 19

The investigator is responsible for each of the following activities, EXCEPT:

a) Promptly providing written reports to the IRB/IEC regarding deviations from or changes to the protocol that are intended to eliminate immediate hazards to the trial subjects
b) Promptly providing written reports to the IRB/IEC regarding changes increasing the risk to subjects and/or affecting significantly the conduct of the trial
c) Ensuring that the trial is conducted properly and that appropriate corrections, additions, or deletions are made, dated, explained (if necessary), and initialed by the monitor and reported to the IRB/IEC
d) Complying with the applicable regulatory requirements related to the reporting of unexpected serious adverse drug reactions to the IRB/IEC

Answer 19

b) Promptly providing written reports to the IRB/IEC regarding changes increasing the risk to subjects and/or affecting significantly the conduct of the trial

4. 5.2
5. 5.4

Question 20

The protocol identifies the following possible mild adverse events related to the Investigational New Drug (IND) medication: loss of appetite, nausea, vomiting, dry mouth, blurred vision, and muscle aches. The protocol identifies the following possible severe adverse events: seizures, heart attack, and stroke.

A subject enrolled in the study experienced a heart attack after taking the IND study medication for approximately 2 months. The subject had a heart attack 10 years ago therefore, the investigator feels this is not related to the IND study medication.

In accordance with the Code of Federal Regulations (CFR), when must an investigator report this event to the sponsor?

a) Does not require reporting
b) Immediately
c) Within one week (7 days)
d) Only in the IND annual report

Answer 20

b) Immediately

CFR 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.