ÌÇÐÄ´«Ã½

A

• AAHRPP: Association for the Accreditation of Human Research Protection ProgramsÌý
• AARC*: Administrative Research Review Committee (Highland Hospital)Ìý
• ACRP: Association of Clinical Research ProfessionalsÌý
• ADE:
  • Adverse Drug Event
  • Adverse Drug ExperienceÌý
• ADME: Absorption, Distribution, Metabolism, and Elimination
• ADR: Adverse Drug ReactionÌý
• AE: Adverse EventÌý
• ALCOAC: Accurate, Legible, Contemporaneous, Original, Attributable, and CompleteÌý
• ARO: Academic Research Organization

B

• BAA: Business Associates AgreementÌý
• BA/BE: Bioavailability/Bioequivalence
• BIMO: Bioresearch Monitoring Program (FDA)Ìý

C

• CABIN*: Center for Advanced Brain Imaging & Neurophysiology (formerly Rochester Center for Brain Imaging)Ìý
• CAPA: Corrective and Preventative ActionÌý
• CART*: Center for Advanced Research Technologies

• CBER: Center for Biologics Evaluation and Research (FDA)Ìý
• CC: Coordinating Center
• CCC: Clinical Coordinating Center
• CCEA: Complete, Consistent, Enduring, Available
• CCRA: Certified Clinical Research AssociateÌý
• CCRC: Certified Clinical Research CoordinatorÌý
• CCRP: Certified Clinical Research ProfessionalÌý
• CDA: Confidential Disclosure Agreement

• CDER: Center for Drug Evaluation and Research (FDA)Ìý
• CDP: Clinical Development Plan
• CDS: Clinical Data System
• CEL*: Center for Experiential LearningÌý
• CFR: Code of Federal RegulationsÌý

• CHeT*: Center for Health and TechnologyÌý
• CIDUR*: Clinical Imaging Data for UR Researchers
• CISCRP: Center for Information and Study on Clinical Research ParticipationÌý

• CIOMS: Council for International Organizations of Medical SciencesÌý
• cIRB: Central Institutional Review BoardÌý
• CITI: Collaborative Institutional Training InitiativeÌý
• CLIA: Clinical Laboratory Improvement AmendmentsÌý
• CME: Continuing Medical Education
• CMSU*: Clinical Materials Service UnitÌý
• CoC: Certificate of Confidentiality
• COI: Conflict of InterestÌý

• CPI: Certified Principal InvestigatorÌý
• CR*: Continuing Review (Click IRB)Ìý
• CRA: Clinical Research AssociateÌý

• CRC:ÌýÌý

• • Clinical Research Center* (CTSI)
  • Clinical Research CoordinatorÌý

• CRF: Case Report FormÌý
• CRO: Clinical Research OrganizationÌý
• CSR: Clinical Study ReportÌý

• CT: Clinical TrialÌý
• CTA: Clinical Trial AgreementÌý
• CTCC*: Clinical Trials Coordination CenterÌý
• CTM: Clinical Trial MaterialÌý

• CTMS: Clinical Trial Management SystemÌý

• CTO*: Clinical Trial Office (Cancer Center)Ìý
• CTPL: Clinical Trials Processing Laboratory
• CTSA: Clinical & Translational Science Award
• CTSI*: Clinical & Translational Science InstituteÌý
• CTTI: Clinical Trials Transformation InitiativeÌý

• CV: Curriculum VitaeÌý

D

• DB: Double BlindÌý
• DCC: Data Coordinating Center
• DCF:ÌýÌý

• • Data Correction FormÌý
  • Data Clarification FormÌý

• DHHS (HHS): Department of Health & Human ServicesÌý
• DM: Data Manager

• DMC: Data Monitoring CommitteeÌý
• DMP: Data Management PlanÌý
• DROIPR*: Department of Radiation Oncology Protocol Review CommitteeÌý
• DSMB: Data and Safety Monitoring BoardÌý
• DSME: Data and Safety Monitoring Entity

• DSMP: Data and Safety Monitoring PlanÌý

• DUA: Data Use AgreementÌý

E

• EAC: Endpoint Adjudication Committee
• EC:ÌýÌý

• • Ethics CommitteeÌý
  • European CommissionÌý

• ECI: Event of Clinical InterestÌý
• eCRF: Electronic Case Report FormÌý
• EDC: Electronic Data CaptureÌý
• EDRA*: Emergency Department Research AssociateÌý
• EHR: Electronic Health RecordÌý

• EIR: Establishment Inspection ReportÌý
• EMR: Electronic Medical RecordÌý
• EMRC*: Emergency Medicine Research CommitteeÌý
• ePRO: Electronic Patient Reported OutcomesÌý

• eTMF: Electronic Trial Master FileÌý

F

• fCOI: Financial Conflict of Interest
• FDA: Food and Drug AdministrationÌý
• FERPA: Family Educational Rights and Privacy Act
• FWA: Federalwide AssuranceÌý

GÌý

• GCP: Good Clinical PracticeÌý
• GDP: Good Documentation Practice
• GDPR: General Data Protection Regulations (European Union)

• GLP: Good Laboratory PracticeÌý
• GMP: Good Manufacturing PracticeÌý

H

• HIPAA: Health Insurance Portability & Accountability ActÌý
• HRPP: Human Research Protection ProgramÌý
• HSP: Human Subject Protection

• HUD: Humanitarian Use DeviceÌý
• HURC*: Human Use of Radiation CommitteeÌý

I

• IB: InvestigatorÌÇÐÄ´«Ã½™s BrochureÌý

• IBC: Institutional Biosafety CommitteeÌý
• ICF: Informed Consent FormÌý
• ICH: International Conference on HarmonisationÌý
• IDE: Investigational Device ExemptionÌý
• IDMC: Independent Data Monitoring CommitteeÌý

• IDS*: Investigational Drug ServiceÌý
• IEC: Independent Ethics CommitteeÌý
• IIT: Investigator-Initiated Trial

• IND: Investigational New DrugÌý
• INDSR: Investigational New Drug Safety ReportÌý
• IO: Institutional OfficialÌý

• IORA*: Integrated Online Research AdministrationÌý
• IP: Investigational ProductÌý
• IRB: Institutional Review BoardÌý
• IRBC*: Institutional Review Board CoordinatorÌý
• IRBD*: Institutional Review Board DirectorÌý
• ISO: International Standards Organization
• ITT: Intent to Treat

• IVRS: Interactive Voice Response SystemÌý
• IWRS: Interactive Web Response SystemÌý

J

• JIT: Just-in-TimeÌý

L

• LAR: Legally Authorized RepresentativeÌý
• LDS: Limited Data SetÌý
• LOI: Letter of Intent
• LTFU: Long Term Follow Up

M

• MAC: Medicare Administration Contractor
• MCA: Medicare Coverage Analysis
• MOD*: Modification (Click IRB)Ìý
• MOD/CR*: Modification & Continuing Review (Click IRB)Ìý
• MOO: Manual of OperationsÌý

• MOP: Manual of ProceduresÌý
• MRCT: Multi-Regional Clinical Trials CenterÌý

• MSS: Multi-Site StudyÌý
• MTA: Material Transfer AgreementÌý

N

• NAF: Notice of Adverse FindingsÌý

• NAI: No Action IndicatedÌý
• NCD: National Coverage Determination
• NCTG*: Neonatal Clinical Trials GroupÌý
• NDA: New Drug ApplicationÌý
• NIH: National Institutes of Health
• NOA: Notice of Award
• NOFO: Notice of Funding Opportunity

• NTF: Note to FileÌý

O

• OAI: Official Action IndicatedÌý
• OCR:ÌýÌý

• • Office of Civil RightsÌý
  • Office of Clinical Research* (CTSI)
• OHRP: Office for Human Research ProtectionsÌý

• OHSP*: Office for Human Subject ProtectionÌý
• OIG: Office of the Inspector General
• ORACS*: Office of Research Accounting and Costing StandardsÌý
• ORC*: Obstetrical Research CommitteeÌý
• ORPA*: Office of Research & Project AdministrationÌý
• ORS*: Office of Regulatory Support (CTSI)
• OSMB: Observational Study Monitoring BoardÌý

• OVPR*: Office of the Vice President for ResearchÌý

P

• PAC: Post-Approval Consultation
• PD: PharmacodynamicÌý
• PHI: Protected Health InformationÌý

• PHS: Public Health ServiceÌý
• PI: Principal InvestigatorÌý
• PIPL: Personal Information Protection Law (China)
• PK/PD: Pharmacokinetic/Pharmacodynamic
• PM: Project ManagerÌý

• PMA: Premarket ApprovalÌý

• PRIM&R: Public Responsibility in Medicine and ResearchÌý
• PRO: Patient Reported OutcomesÌý
• PROMIS: Patient Reported Outcomes Measurement Information SystemÌý
• pSite: Participating Site

Q

• QA: Quality AssuranceÌý

• QC: Quality ControlÌý
• QCT: Qualifying Clinical Trial
• QI: Quality ImprovementÌý
• QMP: Quality Management Plan

R

• RBM: Risk Based MonitoringÌý
• RCT: Randomized Controlled TrialÌý
• RCR: Responsible Conduct of Research

• RDE: Remote Data EntryÌý
• REB: Research Ethics BoardÌý
• RESIN: Rochester Early-Stage Investigator Network
• RHIO: Rochester Regional Health Information Organization
• RMF: Research Methods Forum
• RNI*: Reportable New Information (Click IRB)Ìý
• ROPI: Report of Prior InvestigationsÌý

• RSA: Research Subject AdvocateÌý

• RSRB*: Research Subjects Review BoardÌý

S

• SADE: Serious Adverse Drug ExperienceÌý
• SAE: Serious Adverse EventÌý
• SC:ÌýÌý

• • Safety CohortÌý
  • Study CoordinatorÌý
  • SubcutaneousÌý

• SCORE*: Study Coordinators Organization for Research & EducationÌý

• SCRS: Society for Clinical Research SitesÌý

• SDV: Source Document VerificationÌý
• SI: Sponsor-Investigator
• sIRB: Single Institutional Review BoardÌý
• SIV: Site Initiation Visit
• SMO: Site Management OrganizationÌý
• SO: Safety OfficerÌý
• SOC: Standard of Care
• SOCRA: Society of Clinical Research AssociatesÌý
• SOE: Schedule of Events

• SOP: Standard Operating ProcedureÌý
• SRO: Scientific Review Officer
• SUSAR: Suspected Unexpected Serious Adverse ReactionÌý

T

• TIN: Trial Innovation Network
• TMF: Trial Master FileÌý
• TMO: Trial Management Organization

U

• UADE: Unanticipated Adverse Device EffectÌý
• UADR: Unanticipated Adverse Drug Reaction
• UAP: Unanticipated ProblemÌý
• UPIRTSO: Unanticipated Problem Involving Risk to Subjects or OthersÌý

V

• VAI: Voluntary Action IndicatedÌý

W

• WCG: WIRB Copernicus Group
• WCI PRMC*: Wilmot Cancer Institute Protocol Review and Monitoring Committee
• WIRB: Western Institutional Review Board

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*Specific to the University of Rochester