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21 CFP Part 11 (Electronic Records & Signatures)
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HIPAA Training for Clinical Trial Professionals
CP017a
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199.00
Regulatory Requirements for Clinical Trials in Europe (Directive to Regulation)
CP018a
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Overview of 21 CFR Part 54 Financial Disclosure & Part 11 Electronic Data Signatures
CP016a
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Overview of 21 CFR Part 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA)
CP015a
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Overview of 21 CFR Part 50 Human Subject Protection (HSP) and 21 CFR Part 56 IRB/IEC
CP014a
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199.00
Structure and Content of Clinical Study Reports (ICH E3)
CP013a
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199.00
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)
CP012a
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199.00
Investigator Initiated Clinical Trials
CP011a
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199.00
Medical Device vs. Drug: Comparing and Contrasting
CP010a
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ISO 14155:2020 Medical Device Standard
CP008a
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CRO Oversight
CP007a
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Corrective and Preventive Action (CAPA) Process Planning for Clinical Research Professionals
CP006a
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