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Official Course
Description: MCCCD Approval: 6-24-08 |
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CRC297
2008 Fall – 2010 Summer II |
LEC
3.0 Credit(s) 3.0 Period(s) 3.0 Load Occ |
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Clinical
Trial Material and Device Accountability |
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Overview
of Clinical Trial Material (CTM) from development and manufacturing to
accountability and destruction along with comparable device processes. Roles
of a Clinical Research Associate (CRA) relative to Clinical Trial
Materials/Devices. Investigational New Drug (IND) applications, good
manufacturing practices, importing and exporting of CTMs/devices, packaging
and stability, accountability records, destruction requirements and review of
regulatory considerations. Prerequisites: CRC290. |
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Go to Competencies Go to Outline
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MCCCD
Official Course Competencies: |
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CRC297 2008
Fall – 2010 Summer II |
Clinical Trial Material and Device Accountability |
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1.
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Review and discuss the regulations for controlled
substances, including Drug Enforcement Agency (DEA) regulations for shipping,
storing and destruction of these substances. (I) |
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2.
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Compare and contrast good manufacturing practices for
clinical trial materials versus devices. (I) |
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3.
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Explain timelines associated with global studies
(considering the importation and exportation of clinical trial material). (I)
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4.
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Explain the similarities and differences in an
Investigational New Drug (IND) application and an Investigational Device
Exemption (IDE) process. (I) |
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5.
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Compare and Contrast the Clinical Research Associate (CRA)
role in drug versus device industry. (I, II, IV, V) |
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6.
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Describe the importance of regulatory compliance relative
to investigative products/devices in clinical trials. (I, IV) |
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7.
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Describe regulatory requirements for combination products.
(I, IV) |
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8.
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Audit a pharmacy binder and patient dispensing binder.
(II) |
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9.
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Design regulatory compliant drug and device accountability
logs from both a site and sponsor perspective. (II) |
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10.
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Develop a dispensing plan based upon a mock protocol.
(III) |
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11.
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Design sample drug packages based upon a study protocol.
(III, IV) |
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12.
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Present a training module for a site specifically focusing
on the requirements of drug storage, dispensing, accountability and
destruction. (III, IV, V) |
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13.
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Complete a mock return of Clinical Trial Material from a
site to sponsor/Contract Research Organization. (IV, V) |
Go to Description Go to top of
Competencies
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MCCCD
Official Course Outline: |
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CRC297 2008
Fall – 2010 Summer II |
Clinical Trial Material and Device Accountability |
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I. Regulatory Review A. Investigational New Drug
(IND) versus Investigational Device Exemption (IDE)/Premarket Approval
Application (PMA) B. Good manufacturing
practices C. Drug Enforcement Agency D. Importing and exporting
of Clinical Trial Material E. Special therapeutic
considerations (i.e., oncology, etc.) II. Sponsor versus site A. Documentation on the
sponsor, consultants and Clinical Research Organizations at site level B. Pharmacy binders C. Patient charts D. Compliance III. Study preparation A. Packaging designs B. Dispensing plans and
interactive voice response systems C. Preparation of drug D. Training for sponsor and
site personnel IV. Special considerations A. DEA licenses and requirements
B. Site facility needs C. Oncolytics
D. Labeling requirements
for global trials E. Stability and expiration
dating F. Combination products V. Destruction of material A. Documentation B. Requirements C. Site versus sponsor
versus Clinical Research Organization (CRO) D. United States versus
global E. Unused versus used
investigational materials/devices |
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