| 1.
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Define a minimum of 50 regulatory terms, abbreviations and acronyms
commonly used in research. (I)
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| 2.
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Explain the significance of the Common Rule, Federal Wide Assurances,
and the Code of Federal Regulations (CFR) for research. (II)
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| 3.
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Describe the Food and Drug Administration (FDA) regulations as they
apply to drugs/biologics and medical devices. (III)
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| 4.
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Complete Form 1572 and basic Investigational New Drug (IND) packet for
a sample clinical trial. (III)
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| 5.
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List the 8 elements of an informed consent form (ICF). (IV)
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| 6.
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Complete a submission packet to an Institutional Review Board (IRB)
for a sample clinical trial. (V)
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| 7.
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Recognize situations that may contribute to conflicts of interest.
(VI)
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| 8.
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Describe strategies for resolving conflicts of interest. (VI)
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| 9.
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Describe potential risks associated with behavioral research. (VII)
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| 10.
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Describe when a Certificate of Confidentiality is required. (VII)
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| 11.
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Identify unique aspects of protecting vulnerable subjects with
community-based qualitative research. (VIII)
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| 12.
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Compare and contrast Good Clinical Practice (GCP) and International
Council on Harmonization (ICH) guidelines. (IX)
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| 13.
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Discuss the complexities of the terms "gene transfer" and "genetic
research." (X)
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| 14.
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Identify special/vulnerable populations and related recruitment and
retention strategies. (XI)
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| 15.
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Explain why different research team members including sponsors,
investigators, and universities may have different publication
expectations. (XII)
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| 16.
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Describe the impact of the Health Insurance Portability &
Accountability Act (HIPAA) on the clinical trial research process.
(XIII)
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