Clinical Trial Management (System) Glossary

This page provides CTMS related abbreviations and their corresponding long forms and/or explanations. If you are missing an entry, please do not hesitate to contact us or just leave a comment.

Abbreviation Long Form/Explanation
21 CFR part 11
ADR Adverse Drug Reaction
AE Adverse Event
BBB Blood Brain Barrier
BI Business Intelligence
COV Close-out visit
CPM Clinical Project Manager
CRA Clinical Research Associate
CRF Case Report Form
CRO Clinical Research Organization, Clinical Research Organisation
CSV Comma Seperated Value
CTMS Clinical Trial Management System, sometimes: Clinical Trial Management Software
eCRF Electronic Case Report Form
DBL Data Base Lock
DMS Data Management System
DSUR Development Safety Update Report
DW Data Warehouse
EC Ethics Committee
EDC Electronic Data Capture
EMA European Medicines Agency
EudraCT European Union Drug Regulating Authorities Clinical Trials
GCP Good Clinical Practice
HA Health Authority
IB Investigator’s Brochure
ICF Informed Consent File
ICTR Integrated Clinical Trial Report
ICTR Informed Consent Treatment Report
IMPACT International Management Package for the Administration of Clinical Trials
IRB Institutional Review Board
ISF Investigator Site File
IVRS Interactive Voice Response System
KPI Key Performance Indicator
LPI Last Patient In
MVR Monitoring Visit Report
OQ Operational Qualification
PDF Portable Document File
PI Principal Investigator
PIFI Partner Interface for IMPACT
QCTMS Quality Controlled Trial Management System
QPPV Qualified Person for Pharmacovigilance (sometimes EU-QPPV)
RA Risk Analysis
SAE Serious Adverse Event
SCT Single Country Trial
SDV Source Data Verification
SIV Site Initiation Visit
SMO Site Management Organization
SST Single Site Trial
SUSAR Suspected Unexpected Serious Adverse Reaction
TMF Trial Master File
UAT User Acceptance Test
WPD Work Practice Document
XEVMPD eXtended EudraVigilance Medicinal Product Dictionary