Abbreviations and Acronyms
The acronyms on this page are commonly used across research, especially human subject research. Asterisks (*) indicate that the acronym is specific to the University of Rochester.
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A
- AAHRPP: Association for the Accreditation of Human Research Protection Programs
- AARC*: Administrative Research Review Committee (Highland Hospital)
- ACRP: Association of Clinical Research Professionals
- ADE:
- Adverse Drug Event
- Adverse Drug Experience
- ADME: Absorption, Distribution, Metabolism, and Elimination
- ADR: Adverse Drug Reaction
- AE: Adverse Event
- ALCOAC: Accurate, Legible, Contemporaneous, Original, Attributable, and Complete
- ARO: Academic Research Organization
B
- BAA: Business Associates Agreement
- BA/BE: Bioavailability/Bioequivalence
- BIMO: Bioresearch Monitoring Program (FDA)
C
- CABIN*: Center for Advanced Brain Imaging & Neurophysiology (formerly Rochester Center for Brain Imaging)
- CAPA: Corrective and Preventative Action
- CART*: Center for Advanced Research Technologies
- CBER: Center for Biologics Evaluation and Research (FDA)
- CC: Coordinating Center
- CCC: Clinical Coordinating Center
- CCEA: Complete, Consistent, Enduring, Available
- CCRA: Certified Clinical Research Associate
- CCRC: Certified Clinical Research Coordinator
- CCRP: Certified Clinical Research Professional
- CDA: Confidential Disclosure Agreement
- CDER: Center for Drug Evaluation and Research (FDA)
- CDP: Clinical Development Plan
- CDS: Clinical Data System
- CEL*: Center for Experiential Learning
- CFR: Code of Federal Regulations
- CHeT*: Center for Health and Technology
- CIDUR*: Clinical Imaging Data for UR Researchers
- CISCRP: Center for Information and Study on Clinical Research Participation
- CIOMS: Council for International Organizations of Medical Sciences
- cIRB: Central Institutional Review Board
- CITI: Collaborative Institutional Training Initiative
- CLIA: Clinical Laboratory Improvement Amendments
- CME: Continuing Medical Education
- CMSU*: Clinical Materials Service Unit
- CoC: Certificate of Confidentiality
- COI: Conflict of Interest
- CPI: Certified Principal Investigator
- CR*: Continuing Review (Click IRB)
- CRA: Clinical Research Associate
- CRC:
-
- Clinical Research Center* (CTSI)
- Clinical Research Coordinator
- CRF: Case Report Form
- CRO: Clinical Research Organization
- CSR: Clinical Study Report
- CT: Clinical Trial
- CTA: Clinical Trial Agreement
- CTCC*: Clinical Trials Coordination Center
- CTM: Clinical Trial Material
- CTMS: Clinical Trial Management System
- CTO*: Clinical Trial Office (Cancer Center)
- CTPL: Clinical Trials Processing Laboratory
- CTSA: Clinical & Translational Science Award
- CTSI*: Clinical & Translational Science Institute
- CTTI: Clinical Trials Transformation Initiative
- CV: Curriculum Vitae
D
- DB: Double Blind
- DCC: Data Coordinating Center
- DCF:
-
- Data Correction Form
- Data Clarification Form
- DHHS (HHS): Department of Health & Human Services
- DM: Data Manager
- DMC: Data Monitoring Committee
- DMP: Data Management Plan
- DROIPR*: Department of Radiation Oncology Protocol Review Committee
- DSMB: Data and Safety Monitoring Board
- DSME: Data and Safety Monitoring Entity
- DSMP: Data and Safety Monitoring Plan
- DUA: Data Use Agreement
E
- EAC: Endpoint Adjudication Committee
- EC:
-
- Ethics Committee
- European Commission
- ECI: Event of Clinical Interest
- eCRF: Electronic Case Report Form
- EDC: Electronic Data Capture
- EDRA*: Emergency Department Research Associate
- EHR: Electronic Health Record
- EIR: Establishment Inspection Report
- EMR: Electronic Medical Record
- EMRC*: Emergency Medicine Research Committee
- ePRO: Electronic Patient Reported Outcomes
- eTMF: Electronic Trial Master File
F
- fCOI: Financial Conflict of Interest
- FDA: Food and Drug Administration
- FERPA: Family Educational Rights and Privacy Act
- FWA: Federalwide Assurance
G
- GCP: Good Clinical Practice
- GDP: Good Documentation Practice
- GDPR: General Data Protection Regulations (European Union)
- GLP: Good Laboratory Practice
- GMP: Good Manufacturing Practice
H
- HIPAA: Health Insurance Portability & Accountability Act
- HRPP: Human Research Protection Program
- HSP: Human Subject Protection
- HUD: Humanitarian Use Device
- HURC*: Human Use of Radiation Committee
I
- IB: Investigator’s Brochure
- IBC: Institutional Biosafety Committee
- ICF: Informed Consent Form
- ICH: International Conference on Harmonisation
- IDE: Investigational Device Exemption
- IDMC: Independent Data Monitoring Committee
- IDS*: Investigational Drug Service
- IEC: Independent Ethics Committee
- IIT: Investigator-Initiated Trial
- IND: Investigational New Drug
- INDSR: Investigational New Drug Safety Report
- IO: Institutional Official
- IORA*: Integrated Online Research Administration
- IP: Investigational Product
- IRB: Institutional Review Board
- IRBC*: Institutional Review Board Coordinator
- IRBD*: Institutional Review Board Director
- ISO: International Standards Organization
- ITT: Intent to Treat
- IVRS: Interactive Voice Response System
- IWRS: Interactive Web Response System
J
- JIT: Just-in-Time
L
- LAR: Legally Authorized Representative
- LDS: Limited Data Set
- LOI: Letter of Intent
- LTFU: Long Term Follow Up
M
- MAC: Medicare Administration Contractor
- MCA: Medicare Coverage Analysis
- MOD*: Modification (Click IRB)
- MOD/CR*: Modification & Continuing Review (Click IRB)
- MOO: Manual of Operations
- MOP: Manual of Procedures
- MRCT: Multi-Regional Clinical Trials Center
- MSS: Multi-Site Study
- MTA: Material Transfer Agreement
N
- NAF: Notice of Adverse Findings
- NAI: No Action Indicated
- NCD: National Coverage Determination
- NCTG*: Neonatal Clinical Trials Group
- NDA: New Drug Application
- NIH: National Institutes of Health
- NOA: Notice of Award
- NOFO: Notice of Funding Opportunity
- NTF: Note to File
O
- OAI: Official Action Indicated
- OCR:
-
- Office of Civil Rights
- Office of Clinical Research* (CTSI)
- OHRP: Office for Human Research Protections
- OHSP*: Office for Human Subject Protection
- OIG: Office of the Inspector General
- ORACS*: Office of Research Accounting and Costing Standards
- ORC*: Obstetrical Research Committee
- ORPA*: Office of Research & Project Administration
- ORS*: Office of Regulatory Support (CTSI)
- OSMB: Observational Study Monitoring Board
- OVPR*: Office of the Vice President for Research
P
- PAC: Post-Approval Consultation
- PD: Pharmacodynamic
- PHI: Protected Health Information
- PHS: Public Health Service
- PI: Principal Investigator
- PIPL: Personal Information Protection Law (China)
- PK/PD: Pharmacokinetic/Pharmacodynamic
- PM: Project Manager
- PMA: Premarket Approval
- PRIM&R: Public Responsibility in Medicine and Research
- PRO: Patient Reported Outcomes
- PROMIS: Patient Reported Outcomes Measurement Information System
- pSite: Participating Site
Q
- QA: Quality Assurance
- QC: Quality Control
- QCT: Qualifying Clinical Trial
- QI: Quality Improvement
- QMP: Quality Management Plan
R
- RBM: Risk Based Monitoring
- RCT: Randomized Controlled Trial
- RCR: Responsible Conduct of Research
- RDE: Remote Data Entry
- REB: Research Ethics Board
- RESIN: Rochester Early-Stage Investigator Network
- RHIO: Rochester Regional Health Information Organization
- RMF: Research Methods Forum
- RNI*: Reportable New Information (Click IRB)
- ROPI: Report of Prior Investigations
- RSA: Research Subject Advocate
- RSRB*: Research Subjects Review Board
S
- 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
- SI: Sponsor-Investigator
- sIRB: Single Institutional Review Board
- SIV: Site Initiation Visit
- SMO: Site Management Organization
- SO: Safety Officer
- SOC: Standard of Care
- SOCRA: Society of Clinical Research Associates
- SOE: Schedule of Events
- SOP: Standard Operating Procedure
- SRO: Scientific Review Officer
- SUSAR: Suspected Unexpected Serious Adverse Reaction
T
- TIN: Trial Innovation Network
- TMF: Trial Master File
- TMO: Trial Management Organization
U
- UADE: Unanticipated Adverse Device Effect
- UADR: Unanticipated Adverse Drug Reaction
- UAP: Unanticipated Problem
- UPIRTSO: Unanticipated Problem Involving Risk to Subjects or Others
V
- VAI: Voluntary Action Indicated
W
- WCG: WIRB Copernicus Group
- WCI PRMC*: Wilmot Cancer Institute Protocol Review and Monitoring Committee
- WIRB: Western Institutional Review Board
*Specific to the University of Rochester