Commonly used abbreviations in Pharmaceutical Industry

Commonly used abbreviations in Pharmaceutical Industry

ACRO
Academic Research Organization
CDMoP
Clinical Data Monitoring Plan
CRA
Contract Research Associate
CRO
Contract Research Organization
CSR
Clinical Study Report
CTTI
Clinical Trials Transformation Initiative
DM
Data Manager
DMon
Data Monitoring – All raw and source data review activities by a sponsor that guarantee the protection of trial subject safety and privacy as well as provide assurance that the clinical data meet quality requirements and are fit for purpose. This includes direct (on site) review and verification but also distributed or centralized intra- and inter-site data checks in order to identify trends, signals etc. These activities are usually documented in one or more manuals or plans (such as the CDMoP, DMP, SAP, etc.)
DMP
Data Management Plan
DSci
Data Science –Analytical role enabling the creation of data products that tackle all aspects of a problem, from initial data collection and data conditioning to drawing conclusions across programs
EMA/GCP/INS
European Medicines Agency Good Clinical Practice Inspectors Group
FDA
Food and Drug Administration
GCP
Good Clinical Practices
GxP
Abbreviation for the basket of regulatory guidance for clinical, laboratory, and manufacturing practices

GPvP

Good Pharmacovigilance Practice

ITT
Intent to Treat
IVRS/IWRS
Interactive Voice/ Web Response System
QA
Quality Assurance
QC
Quality Checks Risk-Based Approach
rSDV
Reduced Source Document Verification
SDR
Source Document Review – Process of holistic review of documentation for patient data as indicated by the protocol, e.g. real subject, documents maintained, investigational product.
SDV
Source Document Verification – Process of point-to-point verification of site data entry values between source and database
SAP
Statistical Analysis Plan

STS 

(drug safety ) Signal Tracking System