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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
CSUICI Computerised Systems Used In Clinical Investigations
DSMB Data Safety Monitoring Board
e-CRF electronic Case Report Form
e-DC electronic Data Capture
e-DCF electronic Data Clarification Form
e-PRO electronic Patient-Reported Outcome
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
SDV Source Data Verification
TMF Trial Master File
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