CATEGORY 1
CATEGORY 2
CATEGORY 3
CATEGORY 4
CATEGORY 5
100
ALCOAC

Accurate, legible, contemporaneous, original, attributable, and complete

100
CAPA

Corrective and Preventive Action

100
CRF

Case Report Form

100
CRO

Contract Research Organization

100
CV

Curriculum Vitae

200
EDC

Electronic Data Capture

200
GCP

Good Clinical Practice

200
IB

Investigator’s Brochure

200
IRB

Institutional Review Board

200
IP

Investigational Product

300
LAR

Legally Acceptable Representative

300
PI

Principal Investigator

300
IWRS

Interactive Web Response System

300
SAE

Serious Adverse Event

300
SDV

Source Document Verification

400
SUSAR

Suspected Unexpected Serious Adverse Reaction

400
TMF

Trial Master File

400
PRO

Patient Reported Outcomes

400
DSMB

Data and Safety Monitoring Board

400
DCF

Data Clarification Form

500
CTMS

Clinical Trial Management System

500
CRA

Clinical Research Associate

500
IDMC

Independent Data Monitoring Committee

500
eCRF

Electronic Case Report Form

500
GLP

Good Laboratory Practices