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52 Cards in this Set
- Front
- Back
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ACRP
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Association of Clinical Research Professionals
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ADE
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Adverse Drug Experience
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ADR
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Adverse Drug Reaction
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AE
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Adverse Event
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ARO
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Academic Research Organization
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BLA
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Biologic License Application
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CBER
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Center for Biologics Evaluation ans Research
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CDER
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Center for Drug Evaluation and Research
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CEC
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Clinical Endpoints Committee
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CFR
|
Code of Federal Regulations
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CRA
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Clinical Research Associate
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CRC
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Clinical Research Coordinator
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CRF
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Case Report Form
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CRO
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Contract Research Organization
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CSR
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Clinical Study Report
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DCF
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Data Clarification Form
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DHHS
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Department of Health and Human Services
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DIA
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Drug Information Association
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DSMB
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Data and Safety Monitoring Board
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EC
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Ethics Committee
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eCRF
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electronic Case Report Form
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EDC
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Electronic Drug Capture
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FDA
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Food and Drug Administration
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FWA
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Federalwide Assurance
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GCP
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Good Clinical Practices
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GLP
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Good Laboratory Practices
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GMP
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Good Manufacturing Practices
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HIPAA
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Health Insurance Portability and Accountability Act
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ICH
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International Conference on Harmonisation
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IDE
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Investigational Device Exemption
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IEC
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Independent Ethics Committee
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IND
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Investigational New Drug (application)
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IRB
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Institutional Review Board/Independent Review Board
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IVRS
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Interactive Voice Response System
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NDA
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New Drug Application
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NIH
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National Institutes of Health
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OHRP
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Office for Human Research Protection
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PHI
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Protected Health Information
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PI
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Principal Investigator
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PMA
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Premarket Application
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PMN
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Premarket Notification [510(k)]
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PMS
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Postmarketing Serveillance
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QA
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Quality Assurance
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QI
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Quality Initiative
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QOL
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Quality of Life
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RCT
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Randomized Controlled Trial
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REB
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Research Ethics Board (Canada)
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SAE
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Serious Adverse Event
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SMO
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Site Management Organization
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SoCRA
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Society of Clinical Research Associated
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SOP
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Standard Operating Procedure
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WMA
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World Medical Association
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