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 糖心logo Protection Programs听
- AARC*: Administrative 糖心logo Review Committee (Highland Hospital)听
- ACRP: Association of Clinical 糖心logo Professionals听
- ADE:
- Adverse Drug Event
- Adverse Drug Experience听
- ADME: Absorption, Distribution, Metabolism, and Elimination
- ADR: Adverse Drug Reaction听
- AE: Adverse Event听
- ALCOAC: Accurate, Legible, Contemporaneous, Original, Attributable, and Complete听
- ARO: Academic 糖心logo Organization
B
- BAA: Business Associates Agreement听
- BA/BE: Bioavailability/Bioequivalence
- BIMO: Bioresearch Monitoring Program (FDA)听
C
- CABIN*: Center for Advanced Brain Imaging & Neurophysiology (formerly Rochester Center for Brain Imaging)听
- CAPA: Corrective and Preventative Action听
- CART*: Center for Advanced 糖心logo Technologies
- CBER: Center for Biologics Evaluation and 糖心logo (FDA)听
- CC: Coordinating Center
- CCC: Clinical Coordinating Center
- CCEA: Complete, Consistent, Enduring, Available
- CCRA: Certified Clinical 糖心logo Associate听
- CCRC: Certified Clinical 糖心logo Coordinator听
- CCRP: Certified Clinical 糖心logo Professional听
- CDA: Confidential Disclosure Agreement
- CDER: Center for Drug Evaluation and 糖心logo (FDA)听
- CDP: Clinical Development Plan
- CDS: Clinical Data System
- CEL*: Center for Experiential Learning听
- CFR: Code of Federal Regulations听
- CHeT*: Center for Health and Technology听
- CIDUR*: Clinical Imaging Data for UR 糖心logoers
- CISCRP: Center for Information and Study on Clinical 糖心logo Participation听
- CIOMS: Council for International Organizations of Medical Sciences听
- cIRB: Central Institutional Review Board听
- CITI: Collaborative Institutional Training Initiative听
- CLIA: Clinical Laboratory Improvement Amendments听
- CME: Continuing Medical Education
- CMSU*: Clinical Materials Service Unit听
- CoC: Certificate of Confidentiality
- COI: Conflict of Interest听
- CPI: Certified Principal Investigator听
- CR*: Continuing Review (Click IRB)听
- CRA: Clinical 糖心logo Associate听
- CRC:听听
-
- Clinical 糖心logo Center* (CTSI)
- Clinical 糖心logo Coordinator听
- CRF: Case Report Form听
- CRO: Clinical 糖心logo Organization听
- CSR: Clinical Study Report听
- CT: Clinical Trial听
- CTA: Clinical Trial Agreement听
- CTCC*: Clinical Trials Coordination Center听
- CTM: Clinical Trial Material听
- CTMS: Clinical Trial Management System听
- CTO*: Clinical Trial Office (Cancer Center)听
- CTPL: Clinical Trials Processing Laboratory
- CTSA: Clinical & Translational Science Award
- CTSI*: Clinical & Translational Science Institute听
- CTTI: Clinical Trials Transformation Initiative听
- CV: Curriculum Vitae听
D
- DB: Double Blind听
- DCC: Data Coordinating Center
- DCF:听听
-
- Data Correction Form听
- Data Clarification Form听
- DHHS (HHS): Department of Health & Human Services听
- DM: Data Manager
- DMC: Data Monitoring Committee听
- DMP: Data Management Plan听
- DROIPR*: Department of Radiation Oncology Protocol Review Committee听
- DSMB: Data and Safety Monitoring Board听
- DSME: Data and Safety Monitoring Entity
- DSMP: Data and Safety Monitoring Plan听
- DUA: Data Use Agreement听
E
- EAC: Endpoint Adjudication Committee
- EC:听听
-
- Ethics Committee听
- European Commission听
- ECI: Event of Clinical Interest听
- eCRF: Electronic Case Report Form听
- EDC: Electronic Data Capture听
- EDRA*: Emergency Department 糖心logo Associate听
- EHR: Electronic Health Record听
- EIR: Establishment Inspection Report听
- EMR: Electronic Medical Record听
- EMRC*: Emergency Medicine 糖心logo Committee听
- ePRO: Electronic Patient Reported Outcomes听
- eTMF: Electronic Trial Master File听
F
- fCOI: Financial Conflict of Interest
- FDA: Food and Drug Administration听
- FERPA: Family Educational Rights and Privacy Act
- FWA: Federalwide Assurance听
G听
- GCP: Good Clinical Practice听
- GDP: Good Documentation Practice
- GDPR: General Data Protection Regulations (European Union)
- GLP: Good Laboratory Practice听
- GMP: Good Manufacturing Practice听
H
- HIPAA: Health Insurance Portability & Accountability Act听
- HRPP: Human 糖心logo Protection Program听
- HSP: Human Subject Protection
- HUD: Humanitarian Use Device听
- HURC*: Human Use of Radiation Committee听
I
- IB: Investigator鈥檚 Brochure听
- IBC: Institutional Biosafety Committee听
- ICF: Informed Consent Form听
- ICH: International Conference on Harmonisation听
- IDE: Investigational Device Exemption听
- IDMC: Independent Data Monitoring Committee听
- IDS*: Investigational Drug Service听
- IEC: Independent Ethics Committee听
- IIT: Investigator-Initiated Trial
- IND: Investigational New Drug听
- INDSR: Investigational New Drug Safety Report听
- IO: Institutional Official听
- IORA*: Integrated Online 糖心logo Administration听
- IP: Investigational Product听
- IRB: Institutional Review Board听
- IRBC*: Institutional Review Board Coordinator听
- IRBD*: Institutional Review Board Director听
- ISO: International Standards Organization
- ITT: Intent to Treat
- IVRS: Interactive Voice Response System听
- IWRS: Interactive Web Response System听
J
- JIT: Just-in-Time听
L
- LAR: Legally Authorized Representative听
- LDS: Limited Data Set听
- LOI: Letter of Intent
- LTFU: Long Term Follow Up
M
- MAC: Medicare Administration Contractor
- MCA: Medicare Coverage Analysis
- MOD*: Modification (Click IRB)听
- MOD/CR*: Modification & Continuing Review (Click IRB)听
- MOO: Manual of Operations听
- MOP: Manual of Procedures听
- MRCT: Multi-Regional Clinical Trials Center听
- MSS: Multi-Site Study听
- MTA: Material Transfer Agreement听
N
- NAF: Notice of Adverse Findings听
- NAI: No Action Indicated听
- NCD: National Coverage Determination
- NCTG*: Neonatal Clinical Trials Group听
- NDA: New Drug Application听
- NIH: National Institutes of Health
- NOA: Notice of Award
- NOFO: Notice of Funding Opportunity
- NTF: Note to File听
O
- OAI: Official Action Indicated听
- OCR:听听
-
- Office of Civil Rights听
- Office of Clinical 糖心logo* (CTSI)
- OHRP: Office for Human 糖心logo Protections听
- OHSP*: Office for Human Subject Protection听
- OIG: Office of the Inspector General
- ORACS*: Office of 糖心logo Accounting and Costing Standards听
- ORC*: Obstetrical 糖心logo Committee听
- ORPA*: Office of 糖心logo & Project Administration听
- ORS*: Office of Regulatory Support (CTSI)
- OSMB: Observational Study Monitoring Board听
- OVPR*: Office of the Vice President for 糖心logo听
P
- PAC: Post-Approval Consultation
- PD: Pharmacodynamic听
- PHI: Protected Health Information听
- PHS: Public Health Service听
- PI: Principal Investigator听
- PIPL: Personal Information Protection Law (China)
- PK/PD: Pharmacokinetic/Pharmacodynamic
- PM: Project Manager听
- PMA: Premarket Approval听
- PRIM&R: Public Responsibility in Medicine and 糖心logo听
- PRO: Patient Reported Outcomes听
- PROMIS: Patient Reported Outcomes Measurement Information System听
- pSite: Participating Site
Q
- QA: Quality Assurance听
- QC: Quality Control听
- QCT: Qualifying Clinical Trial
- QI: Quality Improvement听
- QMP: Quality Management Plan
R
- RBM: Risk Based Monitoring听
- RCT: Randomized Controlled Trial听
- RCR: Responsible Conduct of 糖心logo
- RDE: Remote Data Entry听
- REB: 糖心logo Ethics Board听
- RESIN: Rochester Early-Stage Investigator Network
- RHIO: Rochester Regional Health Information Organization
- RMF: 糖心logo Methods Forum
- RNI*: Reportable New Information (Click IRB)听
- ROPI: Report of Prior Investigations听
- RSA: 糖心logo Subject Advocate听
- RSRB*: 糖心logo Subjects Review Board听
S
- SADE: Serious Adverse Drug Experience听
- SAE: Serious Adverse Event听
- SC:听听
-
- Safety Cohort听
- Study Coordinator听
- Subcutaneous听
- SCORE*: Study Coordinators Organization for 糖心logo & Education听
- SCRS: Society for Clinical 糖心logo Sites听
- SDV: Source Document Verification听
- SI: Sponsor-Investigator
- sIRB: Single Institutional Review Board听
- SIV: Site Initiation Visit
- SMO: Site Management Organization听
- SO: Safety Officer听
- SOC: Standard of Care
- SOCRA: Society of Clinical 糖心logo Associates听
- SOE: Schedule of Events
- SOP: Standard Operating Procedure听
- SRO: Scientific Review Officer
- SUSAR: Suspected Unexpected Serious Adverse Reaction听
T
- TIN: Trial Innovation Network
- TMF: Trial Master File听
- TMO: Trial Management Organization
U
- UADE: Unanticipated Adverse Device Effect听
- UADR: Unanticipated Adverse Drug Reaction
- UAP: Unanticipated Problem听
- UPIRTSO: Unanticipated Problem Involving Risk to Subjects or Others听
V
- VAI: Voluntary Action Indicated听
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