All About the Acronyms
The clinical trials industry is known for it’s extensive use of acronyms, which can often be confusing for those not familiar with the field. With numerous regulatory bodies, organizations, and medical terms, it’s no wonder that the industry has a vast array of acronyms. These are used to describe everything from medical conditions to regulatory documents to save time and simplify communication. However, it’s important to ensure that all parties involved have a clear understanding of the acronyms being used to avoid any errors. It’s essential to strike a balance between concise communication and clear comprehension. So, we’ve compiled a list to help you out:
ACA: Affordable Care Act
ADR: Adverse Drug Reaction
AE: Adverse Event
AHRQ: U.S. Agency for Healthcare Research and Quality
AMC: Academic Medical Center
ARO: Academic Research Organization
CDSM: Clinical Data Standard Manager
CDASH: Clinical Data Acquisition Standards Harmonization
CDISC: The Clinical Data Interchange Standards Consortium
COA: Clinical Outcome Assessment
CRA: Clinical Research Associate
CRC: Clinical Research Coordinator
CRF: Case Report Form or Change Request Form
CRO: Clinical Research Organization
CSDD: Center for the Study of Drug Development
CTLC: Clinical Trial Life Cycle
CTMS: Clinical Trial Management System
DB: Database
DCT: Decentralized Clinical Trial
DICOM: Digital Images & Communications in Medicine
DMC: Data Monitoring Committee
eCOA: Electronic Clinical Outcome Assessment
EDC: Electronic Data Capture
EHR: Electronic Health Record
EMA: European Medicines Agency
EMR: Electronic Medical Record
ePRO: Electronic Patient Reported Outcomes
eSource: Electronic Source Data
eTMF: Electronic Trial Master File
FDA: Food and Drug Administration
FIH: First In Human
FPI: First Patient In
GCP: Good Clinical Practice
GDP: Good Documentation Practices
GDPR: General Data Protection Regulation
HIPAA: Health Insurance Portability and Accountability Act
HHS: Department of Health & Human Services
IA: Internal Audit
ICD: Informed Consent Document
ICF: Informed Consent Form
IEC: Independent Ethics Committee
IRB: Institutional Review Board
MOH: Ministry of Health
NDA: New Drug Application
OHRP: Office for Human Research Protections
PHI: Protected Health Information
PI: Principal Investigator
PII: Personally Identifiable Information
PMDA: Pharmaceutical & Medical Devices Agency
QA: Quality Assurance
QC: Quality Control
RTSM: Randomization and Trial Supply Management
SAE: Serious Adverse Event
SD: Software Developer
SDLC: Software Development Lifecycle
SDV: Source Data Verification
SME: Subject Matter Expert
SOP: Standard Operating Procedure
STY: Study
SV(G): Study Verification (Group)
TC: Test Case
UAT: User Acceptance Test
VP: Validation Plan
VR: Validation Report