COMMONLY-USED ABBREVIATIONS AND ACRONYMS IN RESEARCH

*Blue text indicates abbreviations/acronyms that are specific to the University of Rochester*

AAHRPP Association for the Accreditation of Human Research CRC Clinical Research Center
Protection Programs Clinical Research Coordinator
AARC Administrative Research Review Committee (Highland CRF Case Report Form
Hospital) CRO Clinical Research Organization
ACRP Association of Clinical Research Professionals CSR Clinical Study Report
ADE Adverse Drug Experience CT Clinical Trial
ADR Adverse Drug Reaction CTA Clinical Trial Agreement
AE Adverse Event CTCC Clinical Trials Coordination Center
ALCOAC Accurate, Legible, Contemporaneous, Original, CTM Clinical Trail Material
Attributable, and Complete CTMS Clinical Trial Management System
BAA Business Associates Agreement CTO Clinical Trial Office (Cancer Center)
BIMO Bioresearch Monitoring Program (FDA) CTSI Clinical & Translation Science Institute
CABIN Center for Advanced Brain Imaging & Neurophysiology CTTI Clinical Trials Transformation Initiative
(formerly Rochester Center for Brain Imaging) CV Curriculum Vitae
CAPA Corrective and Preventative Action DB Double Blind
CBER Center for Biologics Evaluation and Research (FDA) DCF Data Correction Form
CCRA Certified Clinical Research Associate Data Clarification Form
CCRC Certified Clinical Research Coordinator DHHS (HHS) Department of Health & Human Services
CCRP Certified Clinical Research Professional DMC Data Monitoring Committee
CDER Center for Drug Evaluation and Research (FDA) DMP Data Management Plan
CEL Center for Experiential Learning DROIPR Department of Radiation Oncology Protocol Review
CFR Code of Federal Regulations Committee
CHET Center for Human Experimental Therapeutics DSMB Data and Safety Monitoring Board
CISCRP Center for Information and Study on Clinical Research DSMP Data and Safety Monitoring Plan
Participation DUA Data Use Agreement
CIOMS Council for International Organizations of Medical EC Ethics Committee; European Commission
Sciences ECI Event of Clinical Interest
cIRB Central Institutional Review Board eCRF Electronic Case Report Form
CITI Collaborative Institutional Training Initiative EDC Electronic Data Capture
CLIA Clinical Laboratory Improvement Amendments EDRA Emergency Department Research Associate
CMSU Clinical Materials Service Unit EHR Electronic Health Record
COI Conflict of Interest EIR Establishment Inspection Report
CPI Certified Principal Investigator EMR Electronic Medical Record
CR Continuing Review (Click IRB) EMRC Emergency Medicine Research Committee
CRA Clinical Research Associate ePRO Electronic Patient Reported Outcomes

Version Date: 21JUL2022

 COMMONLY-USED ABBREVIATIONS AND ACRONYMS IN RESEARCH
*Blue text indicates abbreviations/acronyms that are specific to the University of Rochester*

eTMF Electronic Trial Master File MRCT Multi-Regional Clinical Trials Center
FDA Food and Drug Administration MSS Multi-Site Study
FWA Federalwide Assurance MTA Material Transfer Agreement
GCP Good Clinical Practice NAF Notice of Adverse Findings
GLP Good Laboratory Practice NAI No Action Indicated
GMP Good Manufacturing Practice NCTG Neonatal Clinical Trials Group
HIPAA Health Insurance Portability & Accountability Act NDA New Drug Application
HRPP Human Research Protection Program NTF Note to File
HUD Humanitarian Use Device OAI Official Action Indicated
HURC Human Use of Radiation Committee OCR Office of Civil Rights
HSP Human Subject Protection Office of Clinical Research
IB Investigator’s Brochure OHRP Office for Human Research Protections
IBC Institutional Biosafety Committee OHSP Office for Human Subject Protection
ICF Informed Consent Form ORACS Office of Research Accounting and Costing Standards
ICH International Conference on Harmonisation OIG Office of the Inspector General
IDE Investigational Device Exemption ORC Obstetrical Research Committee
IDMC Independent Data Monitoring Committee ORPA Office of Research & Project Administration
IDS Investigational Drug Service OSMB Observational Study Monitoring Board
IEC Independent Ethics Committee PD Pharmacodynamic
IND Investigational New Drug PHI Protected Health Information
INDSR Investigational New Drug Safety Report PHS Public Health Service
IO Institutional Official PI Principal Investigator
IORA Integrated Online Research Administration PRC Peer Review Committee (Cancer Center)
IP Investigational Product PM Project Manager
IRB Institutional Review Board PMA Premarket Approval
IRBC Institutional Review Board Coordinator PRIM&R Public Responsibility in Medicine and Research
IRBD Institutional Review Board Director PRO Patient Reported Outcomes
IVRS Interactive Voice Response System PROMIS Patient Reported Outcomes Measurement
IWRS Interactive Web Response System Information System
LAR Legally Authorized Representative QA Quality Assurance
LDS Limited Data Set QC Quality Control
MOD Modification (Click IRB) QI Quality Improvement
MOD/CR Modification & Continuing Review (Click IRB) RBM Risk Based Monitoring
MOO Manual of Operations RCT Randomized Controlled Trial
MOP Manual of Procedures RDE Remote Data Entry

Version Date: 21JUL2022

 COMMONLY-USED ABBREVIATIONS AND ACRONYMS IN RESEARCH
*Blue text indicates abbreviations/acronyms that are specific to the University of Rochester*

REB Research Ethics Board

RNI Reportable New Information (Click IRB)
ROPI Report of Prior Investigations
RSA Research Subject Advocate
RSRB Research Subjects Review Board
SADE Serious Adverse Drug Experience
SAE Serious Adverse Event
SC Safety Cohort
Study Coordinator
Subcutaneous
SCORE Study Coordinators Organization for Research &
Education
SCRS Society for Clinical Research Sites
SDV Source Document Verification
sIRB Single Institutional Review Board
SMO Site Management Organization
SO Safety Officer
SOCRA Society of Clinical Research Associates
SOP Standard Operating Procedure
SUSAR Suspected Unexpected Serious Adverse Reaction
TMF Trial Master File
UADE Unanticipated Adverse Device Effect
UAP Unanticipated Problem
UPIRTSO Unanticipated Problem Involving Risk to Subjects or
Others
VAI Voluntary Action Indicated
WIRB Western Institutional Review Board

Version Date: 21JUL2022