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ABBREVIATIONS

CDISC Clinical Data Interchange Standards Consortium
CEC Critical Event Committee
CFR Code of Federal Regulations
CIOMS Council for International Organisations of Medical Sciences
CRA Clinical Research Associate
e-CRF electronic Case Report Form
e-DC electronic Data Capture and Management
e-DCF electronic Data Clarification Form
e-SOCDAT electronic Source Consultation Data Acquisition Tool
e-STA electronic Study Treatment Administration
FDA Food and Drug Administration
GCP Good Clinical Practices
ICH International Conference on Harmonisation
ODM Operational Data Model
SAE Serious Adverse Event
TMF Trial Master File
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