Quebec
PI
Principal Investigator
CRO
Clinical Research Organization
SDA
Source Document Agreement
IRB
Institutional Review Board
IWRS
IRT
Interactive Web Response System
Interactive Response Technology
PRO
Patient Reported Outcomes
CTA
Clinical Trial Agreement
Clinical Trial Assistant
eCRF
EDC
Electronic Case Report Form
Electronic Data Capture
OU
Both eyes
IMV
Interim Monitoring Visit
eREG
Electronic Regulatory
IEC
Independent Ethics Commitee
QC
QMS
QA
Quality Control
Quality Management System
Quality Assurance
QD
Once a day
AESI
Adverse Event of Special Interest
CRA
Clinical Research Associate
ICF
Informed Consent Form
IND
Investigational New Drug
CS
NCS
Clinically Significant
Not Clinically Significant
CAPA
Corrective Action, Preventative Action
CRC
Clinical Research Coordinator
AE/SAE
Adverse Event/ Serious Adverse Event
SOP
Standard Operating Procedures
eTMF
Electronic Trial Master File
CTSI
Clinical Trial Site Information