Short List of Commonly Used Acronyms in Clinical Research
700U Statement of Economic Interest
ACRP Association of Clinical Research Professionals
AE Adverse Event
ADR Adverse Drug Reaction
AMA American Medical Association
BID Twice Daily
BIND BiologicalIND
CAP Collegeof American Pathologists
CBCTN Community Based Clinical Trials Network
CBER Centerfor Biologics Evaluation and Research (FDA)
CCRA Certified Clinical Research Associate (ACRP)
CCRC Certified Clinical Research Coordinator (ACRP)
CCRC CTSC ClinicalResearchCenter
CCRP Certified Clinical Research Professional (SoCRA)
CDA Confidential Disclosure Agreement
CDC Centerfor Disease Control
CDER Centerfor Drug Evaluation and Research (FDA)
CDRH Centerfor Devices and Radiological Health (FDA)
CF Consent Form
CFR Code of Federal Regulations
CLIA Clinical Laboratory Improvement Amendments
CME Continuing Medical Education
CP Compliance Program (FDA)
COI Conflict of Interest
CRA Clinical Research Associate CTSC Clinical Research Training Program
CRC Clinical Research Coordinator
CRF Case Report Form
CRO Clinical Research Organization
CT Clinical Trial
CTA Clinical Trial Agreement
CS Clinically Significant
CSA Clinical Service Agreement
CTSC Clinical and TranslationalScienceCenter
CV Curriculum Vitae
DCF Data Correction Form / Data Clarification Form
DEA Drug Enforcement Agency (law enforcement division of FDA)
DHHS Department of Health & Human Services
DOS Description of Study
EAB Ethical Advisory Board (similar to IRB, used by other nations)
EDC Electronic Data Capture
FDA Food and Drug Administration
FDA-482 Notice of Inspection
FDA-483 Notice of Adverse Findings in an Inspection
FDA-1572 FDA Form for New Drug Application
FDA-1572 FDA Form for Statement of Investigator
FDA-SRS Spontaneous Reporting System of the FDA
FDCA Food, Drug, and Cosmetic Act
FOIA Freedom of Information Act
FTC Federal Trade Commission
GCP Good Clinical Practice
GDA Global Disclosure Agreement
GLP Good Laboratory Practice CTSC Clinical Research Training Program
GMP Good Manufacturing Practice
HIPAA Health Insurance Portability and Accountability Act
HHS Health and Human Services (Department of)
HMO Health Maintenance Organization
IACUC Institutional Animal Care and Use Committee (IRB for animal use)
IB Investigator’s Brochure
ICF Informed Consent Form
ICH International Conference on Harmonisation
IDB Investigational Drug Brochure
IDE Investigational Device Exemption
IDS Investigational Drug Service (pharmacy)
INAD Investigational New Animal Drug (FDA)
INDInvestigational New Drug
IRB Institutional Review Board
JCAHO Joint Commission of Accreditation of Health Care Organizations
LOA Letter of Agreement
MDR Medical Device Reporting
MOU Memoranda of Understanding
MRA Medical Research Associate
NAI No Action Indication (most favorable post-FDA inspection classification)
NCI National Cancer Institute
NCS Not Clinically Significant
NDA New Drug Application
NHLBI National Heart, Lung, and Blood Institute
NIAID National Institute of Allergy and Infectious Diseases CTSC Clinical Research Training Program
NIH National Institutes of Health
NIMH National Institute of Mental Health
NKA No Known Allergies
OAI Official Action Indicated (serious post-FDA inspection classification)
OHRP Office for Human Research Protection
OSHA Occupational Safety and Health Administration
OTC Over-the-counter (non-prescription drugs)
OVCR Office of the Vice Chancellor for Research
PCCPoisonControlCenter
PD Pharmacodynamics
PDQ Physician’s Data Query (NCI sponsored cancer trial registry)
PDR Physician’s Desk Reference
PE Physical Examination
PHI Protected Health Information
PI Package Insert
PI Principal Investigator
PK Pharmacokinetics
PLA Product License Application (when seeking commercialization of a biologic)
PMA Pre-Market Approval (when seeking commercialization of a device)
POBy Mouth
PPE Personal Protective Equipment
PPI Patient Package Inserts
PPO Preferred Provider Organization
PRN As Needed
QA Quality Assurance
QC Quality Control
QD Every day CTSC Clinical Research Training Program
QID Four Times a Day
QOL Quality of Life
R&D Research and Development
RDE Remote Data Entry
RL Regulatory Letter (post-FDA audit letter)
Rx. Prescription
SAE Serious Adverse Event
SC Study Coordinator
SD Source Document
SMO Site Management Organization
SoCRA Society of Clinical Research Associates
SOMSchoolof Medicine
SOP Standard Operating Procedure
SRA Staff Research Associate
TID Three Times a Day
UNK Unknown
USPU.S.Pharmacopeia
VAUnited StatesDepartment of Veterans Affairs
VAI Voluntary Action Indicated (post-FDA audit inspection classification)
VS Vital Signs
WHO World Health Organization
WL Warning Letter
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