Abbreviations and Acronyms

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) 
• CCEA: Complete, Consistent, Enduring, Available
• CCRA: Certified Clinical Research Associate 
• CCRC: Certified Clinical Research Coordinator 
• CCRP: Certified Clinical Research Professional 

• 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 
• 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) 
• CTSI*: Clinical & Translation Science Institute 
• CTTI: Clinical Trials Transformation Initiative 

• CV: Curriculum Vitae 

D

• DB: Double Blind 
• 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 

• 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 

L

• LAR: Legally Authorized Representative 
• LDS: Limited Data Set 
• 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 
• NOA: Notice of Award

• 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 
• RHIO: Rochester Regional Health Information Organization
• 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 
• sIRB: Single Institutional Review Board 
• 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 
• SUSAR: Suspected Unexpected Serious Adverse Reaction 

T

• 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