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Regulatory Updates for Clinical Research Professionals Learning

Module v.16

This Learning Module is intended to encourage the reader to maintain an understanding of current activities

involved in the conduct of research involving human subjects. The module offers one SOCRA continuing

education unit to those who complete the review and correctly answer ten of eleven questions.

The module is offered at no cost as a public service. The readers should complete the module at their own pace –

there is no time limit.

Once the questions have been answered "off-line," please proceed to the "on-line" module to complete this

process and to print your certificate of completion.

When you are prepared to access the "on-line" module, please go to https://socra.elevate.commpartners.com/ ,

and either login or create a new account to complete the "on-line" module, and to receive your certificate of

completion.

Acronyms used:

CFR United States Code of Federal Regulations (US FDA regulations)

DSMB Data Safety Monitoring Board

GCP Good Clinical Practice

ICH International Conference on Harmonisation

IDE Investigational Device Exemption

IRB/IEC Institutional Review Board/Independent Ethics Committee

NIH National Institutes of Health

NSR Non-Significant Risk

OHRP Office for Human Research Protections

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We suggest you print and review the following documents and answer ALL questions "off-line." Once the questions have been answered "off-line," please proceed to the "on-line" module to complete this process and to print your certificate of completion. This module offers one SOCRA continuing education unit.

1. The Declaration of Helsinki (2013) 2. ICH/E6(R2) (International Conference on Harmonization of

Technical Requirements for Registration of Pharmaceuticals for Human Use and its Efficacy Guidelines) 3. 21 CFR 312.32 and 21 CFR 312.64

Please circle the correct answer for each question below:

Answer question 1 after reviewing the following information:

https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ for Declaration of Helsinki 2013

1. 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

Please review The Declaration of Helsinki to answer questions 2, 3, 4, and 5.

https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-

involving-human-subjects/

2. 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

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3. 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

4. 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

5. 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 by 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

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Please review ICH/GCP E6(R2) to answer questions 6, 7, 8, 9 and 10.

http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf

6. 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

7. 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

8. 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

9. 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

10. 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

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Refer to 21 CFR 312.32 and 21 CFR 312.64 to answer question 11.

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.

11. 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