Category 1
ALCOA-C
Accurate
Legible
Contemporaneous
Original
Attributable
Complete
CAPA
Corrective Action and Preventive Action
CRF
Case Report Form
CRO
Contract Research Organization
CV
Curriculum Vitae
EDC
Electronic Data Capture
GCP
IB
Investigator's Brochure
IRB
Institutional Review Board
IP
Investigational Product
LAR
Legally Acceptable Representative
PI
Principal Investigator
IWRS
Interactive Web Response System
SAE
Serious Adverse Event
SDV
Source Document Verification
SUSAR
Suspected Unexpected Serious Adverse Reaction
TMF
Trial Master File
PRO
Patient Reported Outcomes
DSMB
Data and Safety Monitoring Board
DCF
Data Clarification Form
Clinical Trial Management System
CRA
Clinical Research Associate (aka Monitor)
IDMC
Independent Data Monitoring Committee
ECRF
Electronic Case Report Form
GLP
Good Laboratory Practices