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Official Course
Description: MCCCD Approval: 6-24-08 |
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CRC295
2008 Fall – 2010 Summer II |
LEC
3.0 Credit(s) 3.0 Period(s) 3.0 Load Occ |
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Ethics
and Regulations |
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Overview
of the regulations, guidelines and resources associated with the Clinical
Research Associate (CRA) role. Monitoring responsibilities, Code of Federal
Regulations, International Conference of Harmonisation
(ICH) guidelines, European Directives, Pharmaceutical Research and
Manufacturers of America (PhRMA) principles, Food
and Drug Administration (FDA) Guidelines for the Monitoring of Clinical
Investigations and sponsor responsibilities for conduct of clinical trials
and approval. Prerequisites: CRC290. |
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Go to Competencies Go to Outline
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MCCCD
Official Course Competencies: |
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CRC295 2008
Fall – 2010 Summer II |
Ethics and Regulations |
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1.
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Compare and contrast International Conference of Harmonisation (ICH) guidelines and Code of Federal
Regulations for the monitoring of clinical trials. (I) |
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2.
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Explain current regulatory and ethical issues involved
with sponsored Food and Drug Administration (FDA) clinical trials. (I, III) |
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3.
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Create a regulatory-compliant biological sample shipping
Standard Operating Procedure (SOP). (I, III) |
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4.
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Develop a standard regulatory binder to be utilized at a
site and sponsor level. (II) |
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5.
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Describe the significance of the components of an
Investigational New Drug (IND) application and an Investigational Device
Exemption (IDE). (II) |
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6.
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Complete a Serious Adverse Event form and create a
timeline for notifying the Food and Drug Administration of the event. (II) |
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7.
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Audit a Regulatory Binder. (II, IV) |
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8.
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Complete a start-up packet for an investigator site (Form
1572, Financial Disclosure, Curriculum Vitae, Investigator's Brochure, etc.)
. (II, V) |
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9.
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Explain electronic regulations and implications of
misinterpretation. (III) |
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10.
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Describe common regulatory findings from past FDA audits
and develop preventive strategies to address the five most common findings.
(IV) |
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11.
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Compare and contrast device versus drug/biologics
regulations from the CRA/sponsor perspective. (IV) |
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12.
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Explain emergency research and life threatening diseases
regulatory oversight. (IV) |
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13.
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Compare and contrast sponsor versus site regulations for
study start-up. (V) |
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14.
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Describe the regulatory bodies involved in an
international study, and the role of the CRA in an international study. (VI) |
Go to Description Go to top of
Competencies
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MCCCD
Official Course Outline: |
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CRC295 2008
Fall – 2010 Summer II |
Ethics and Regulations |
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I. Clinical Trial
Regulatory/Ethical Oversight Organizations A. International Conference
of Harmonisation B. Food and Drug
Administration C. Office of Human Subjects
Protection D. Other types of
oversight, (i.e., DEA, Office of Inspector General, etc.) II. Regulatory
Documentation A. Regulatory Binders B. Serious Adverse Events C. Investigational New Drug
applications D. Investigational Device
exemptions E. Other required/good
clinical practice documents III. Contemporary
ethical/regulatory Issues A. Electronic data
regulations B. Pharmacogenomic
studies C. Personalized medicine D. Biospecimen
studies E. Device study issues IV. FDA oversight A. Regulatory oversight B. Consequences of
noncompliance C. FDA audits and the CRA's
role D. Device versus
drugs/biologic regulations E. Combination regulations F. Other issues V. Regulatory requirements
in study progress A. Start-up B. During study C. Close out of study D. Special issues VI. International (Global)
Studies A. CRA's role B. Regulatory oversight C. Information resources D. Special issues |
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