Section 1: Alphabetical List (All Acronyms)
AACI – Association of American Cancer Institutes
AAHRPP – Association for the Accreditation of Human Research Protection Program
ABSA – Association of Biosafety and Biosecurity
ACA – Patient Protection and Affordable Care Act (Abbreviated version)
ACE – Adverse Clinical Event
ACRP – Association of Clinical Research Professional
ACTS – Association for Clinical and Translational Science
ADE – Adverse Drug Effect/Event
ADME – Absorption, Distribution, Metabolism, and Excretion
ADR – Adverse Drug Reaction
AE – Adverse Event
AESI – Adverse Event of Special Interest
ALCOA – Attributable, Legible, Contemporaneous, Original, Accurate
AMA – American Medical Association
ANDA – Abbreviated New Drug Application (revised)
ANOVA – Analysis of Variance
API – Active Pharmaceutical Ingredient / Application Program Interface
ARO – Academic Research Organization
ASGCT – American Society of Gene & Cell Therapy
AUC – Area Under the Curve (pharmacokinetics)
BA – Bioavailability
BAA – Business Associate Agreement
BCE – Beneficial Clinical Event
BE – Bioequivalence
BIND – Biological Investigational New Drug
BLA – Biologics License Agreement
BMI – Body Mass Index
BSA – Body Surface Area
BT – Biotechnologies
CANDA – Computer Assisted New Drug Application (largely replaced by eCTD)
CAPA – Corrective and Preventative Actions Process
CAPLA – Computer Assisted Product License Application (obsolete terminology)
CBER – Center for Biologics Evaluation and Research
CCI – Certified Clinical Investigator (DIA)
CCRA – Certified Clinical Research Associate (ACRP)
CCRC – Certified Clinical Research Coordinator (ACRP)
CCRP – Certified Clinical Research Professional (SoCRA)
CCTI – Certified Clinical Trial Investigator (ACRP)
CDA – Confidential Disclosure Agreement
CDASH – Clinical Data Acquisition Standards Harmonization (CDISC)
CDER – Center for Drug Evaluation and Research
CDISC – Clinical Data Interchange Standards Consortium
CDM – Clinical Data Management
CDRH – Center for Devices and Radiological Health
CE – Continuing Education
CEU – Continuing Education Unit
CFR – Code of Federal Regulations
CITI – Collaborative Institutional Training Initiative
CLIA – Clinical Laboratory Improvements Amendments
CME – Continuing Medical Education
CMS – Centers for Medicare & Medicaid Services
CNS – Central Nervous System
COA – electronic Clinical Outcome Assessment
COI – Conflict of Interest
COV – Close-Out Visit
CPSC – Consumer Product Safety Commission
CRA – Society for Clinical Research Associates
CRA – Clinical Research Associate
CRC – Clinical Research Coordinator
CRCP – (rarely used; MAGI designation)
CRF – Electronic Case Report Form
CRCP – Clinical Research Contract Professional (MAGI)
CRF – Case Report Form
CRO – Contract Research Organization
CS – Clinically Significant
CSO – Consumer Safety Officer (FDA)
CSR – Clinical Study Report
CSV – Computer System Validation
CTA – Clinical Trial Agreement
CTA – Clinical Trial Assistant
CTM – Clinical Trials Manager
CTMS – Clinical Trial Management System
CTR – EU Clinical Trials Regulation (Regulation (EU) No 536/2014)
CTSC – Clinical & Translational Science Collaborative
CV – Curriculum Vitae
DB – Double Blind
DBL – Database Lock
DCF – Data Correction/Clarification Form
DCT – Decentralized Clinical Trial
DE – Data Entry
DEA – Drug Enforcement Administration
DGR – Dangerous Goods Regulation
DHHS – Department of Health and Human Services
DIA – Drug Information Association
DM – Data Manager
DRA – Medical Dictionary for Regulatory Activities
DSMB – Data and Safety Monitoring Board
DSMC – Data and Safety Monitoring Committee
DV – Data Verification
ED – Effective Dose
EDC – Electronic Data Capture
EHR – Electronic Health Record
EIR – Establishment Inspection Report
ELA – Establishment License Application (replaced by BLA/PMA)
EMA – European Medicines Agency
EMR – Electronic Medical Record
EOS – End of Study
EPL – Effective Patent Life
ERS – Electronic Regulatory Submission
ETT – Exercise Tolerance Test
EUA – Emergency Use Authorization (FDA)
FCI – For-Cause Inspection
FDA – Food and Drug Administration
FDAMA – FDA Modernization Act
FDF – Finished Dosage Form
FPI – First Patient In
FTC – Federal Trade Commission
FWA – Federalwide Assurance (OHRP)
GCP – Good Clinical Practices
GLP – Good Laboratory Practices
GMP – Good Manufacturing Practices
GMP – current Good Manufacturing Practice
GRAS – Generally Recognized as Safe
HCPCS – Healthcare Common Procedural Coding System
HHS – U.S. Department of Health and Human Services (revised)
HIM – Health Information Management
HIPAA – Health Insurance Portability and Accountability Act
HPA – Human Protections Administration
HRPP – Human Research Protection Program
IATA – International Air and Transport Association
IB – Investigator Brochure
IC – Informed Consent
ICF – Informed Consent Form
ICH – International Council for Harmonisation (revised)
ICH – International Council for Harmonisation
ICSR – Individual Case Safety Report
IDC – Indirect Cost
IDE – Investigational Device Exemption (revised)
IEC – Independent Ethics Committee
IFU – Instructions for Use
IM – Investigator Meeting
IMP – Investigational Medicinal Product (EU)
IMPD – Investigational Medicinal Product Dossier (EU)
IMV – Interim Monitoring Visit
IND – Investigational New Drug
INDA – Investigational New Drug Application
IP – Investigational Product
IRB – Institutional Review Board
IRB – Central Institutional Review Board
IRT – Interactive Response Technology
ISF – Electronic Investigator Site File
ISF – Investigator Site File
ISO – International Organization for Standardization (revised)
IVRS – Interactive Voice Response System
IWRS – Interactive Web Response System
JCAHO – Joint Commission on Accreditation of Healthcare Organizations (now The Joint Commission)
KOL – Key Opinion Leader
KPI – Key Performance Indicator
KRI – Key Risk Indicator
LD – Lethal Dose
LOC – Level of Concern
LPO – Last Patient Out (Last Patient Last Visit)
MAA – Marketing Authorization Application (revised)
MCC – Metrics Champion Consortium
MDR – Medical Device Reporting (revised)
MDV – Medical Device Vigilance
MHRA – Medicines and Healthcare products Regulatory Agency (UK)
MP – Monitoring Plan
MPA – Multiple Project Assurance (retired; replaced by FWA)
MRA – Medical Research Associate
MSDS – Material Safety Data Sheets
MTD – Maximum Tolerated Dose
NAF – Notice of Adverse Findings
NAI – No action Indicated
NBAC – National Bioethics Advisory Commission (disbanded in 2001)
NCE – New Chemical Entity
NCI – National Cancer Institute
NCQA – National Committee for Quality Assurance
NCR – No Carbon Required (archaic, paper-based reference)
NCS – Not Clinically Significant
NDA – New Drug Application
NDI – National Death Index
NDS – New Drug Study (outdated; NDA is standard)
NIH – National Institutes of Health
NIOSH – National Institute for Occupational Safety and Health
NME – New Molecular Entity
NP – Nurse Practitioner
NSR – Non-Significant Risk Device Studies
OAI – Official Action Indicated
OCR – Office for Civil Rights
OHRP – Office for Human Research Protections
OIG – Office of Inspector General
OSHA – Occupational Safety and Health Administration (revised)
OTC – Over-The-Counter
PA – Physician Assistant
PAR – Post-Approval Research
PASI – Psoriasis Area Severity Index
PD – Pharmacodynamic
PDQ – Physician Data Query
PDR – Physician Desk Reference (print reference discontinued; brand persists online)
PHI – Protected Health Information
PHRP – Partnership for Human Research Protection (inactive initiative)
PI – Principal Investigator
PICO – Population, Intervention, Comparison, Outcome framework
PII – Phase II Clinical Trial
PIII – Phase III Clinical Trial
PK – Pharmacokinetics
PKPD – Pharmacokinetics and Pharmacodynamics
PLA – Product License Application
PM – Project Manager
PMA – Pre-Market Approval Application
PMS – Post Market Surveillance
PPACA – Patient Protection and Affordable Care Act
PRO – Electronic Patient Reported Outcomes
PSV – Pre-Study Visit
PTC – Points to Consider
PV – Pharmacovigilance
QA – Quality Assurance
QC – Quality Control
QOL – Quality of Life
RBM – Risk-Based Monitoring
RBQM – Risk-Based Quality Management
RDC – Remote Data Capture
RDE – Remote Data Entry Reg. Reference to “Regulatory” documents
REMS – Risk Evaluation and Mitigation Strategy (FDA)
RMA – Pharmaceutical Research and Manufacturers of America (revised)
ROA – Route of Administration
RWD – Real-World Data
RWE – Real-World Evidence
SAE – Serious Adverse Event
SAP – Statistical Analysis Plan
SC – Study Coordinator
SDTM – Study Data Tabulation Model (CDISC)
SDV – Source Data Verification
SI – Sub-Investigator
SIC – So is Correct (likely erroneous entry)
SIV – Site Initiation Visit
SME – Significant Medical Event
SMO – Site Management Organization
SNDA – Supplemental New Drug Application
SOC – Standard of Care
SOP – Standard Operating Procedures
SPA – Single Project Assurance (retired OHRP assurance; note FDA SPA = Special Protocol Assessment)
SR – Significant Risk Study
SSV – Site Selection Visit
SUSAR – Suspected Unexpected Serious Adverse Reaction
TESS – Treatment Emergent Signs and Symptoms
TMF – Trial Master File
TMF – Electronic Trial Master File
TPD – Trial Product Disposition
UAT – User Acceptance Testing
USP – United States Pharmacopeia (revised)
WHO – World Health Organization
WOMAC – Western Ontario and McMaster Universities Osteoarthritis Index
