Wednesday, February 8, 2012

Are you clinical research professional so you should know about this reference post..,:)

Hello readers here most commonly used abbreviations in Clinical Research were included. This list could be useful as absolute reference. If you need any reference search by pressing by Ctrl+F and type your word, you can find your word. If you have any abbreviations which are not included in this list, please include in your comments.

A
AABB- American Association of Blood Banks
AADA- Abbreviated Antibiotic Drug Application
AAPS- American Association of Pharmaceutical Scientists
Ab- Antibody
ABEP- Auditory Brainstem-Evoked Potential
ABPI- Association of British Pharmaceutical Industries
AC- Before Meals
ACE- Adverse Clinical Event
ACIL- American Council of Independent Laboratories
ACRA- Associate Commissioner of Regulatory Affairs (FDA)
ACRP- Association of Clinical Research Professionals
ACRPI- Association for Clinical Research in the Pharmaceutical Industry (United
Kingdom)
ACT -Applied Clinical Trials (industry journal)
AD- Alzheimer's Disease
AD- Antidepressant
ADAMHA- Alcohol, Drug Abuse and Mental Health Administration
ADAS Alzheimer's Disease Assessment Scale
ADE- Adverse Drug Event
ADME- Absorption, Distribution, Metabolism, and Excretion (criteria affecting activity of a drug within an organism)
ADR- Adverse Drug Reaction
AE- Adverse Event
AED- Antiepileptic Drugs
AHRQ- Agency for Healthcare Research and Quality
AIDS- Acquired Immunodeficiency SyndromeResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
AKA- Above-the-Knee Amputation
ALT- Alanine Aminotransferase (formerly SGPT, liver enzyme)
AMA- American Medical Association, American Management Association, against medical advice
AmFAR American Foundation for AIDS Research
AMG- West Germany Drug Law (Germany's equivalent to Food, Drug and
Cosmetic Act)
AMI- Acute Myocardial Infarction
ANDA- Abbreviated New Drug Application (used for generics)
AOACI- Association of Official Analytical Chemists International
APHIS- Animal and Plant Health Inspection Service (USDA)
ARC- AIDS-Related Complex
ARDS- Adult Respiratory Distress Syndrome
ASCPT- American Society for Clinical Pharmacology and Therapeutics
AST- Aspartate Aminotransferase (also known as SGOT, liver enzyme)
ATF- Bureau of Alcohol, Tobacco and Firearms (US Department of Justice)
AZT- Zidovudine (HIV treatment)

B
BAER- Brainstem Auditory-Evoked Potential
BCE- Beneficial Clinical Event
BEUC- European Consumers’ Organisation
BGA- Bundesgesundheitsamt (Germany's equivalent to FDA)
BID- Twice a Day
BIND- Biological IND
BKA- Below-the-Knee Amputation
BMI- Body Mass Index
BMR- Basil metabolic rate
BP- Blood Pressure
BPAD- Bipolar Affective DisorderResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
BPM- Beats per Minute
BSA- Body Surface Area
BSN- Bachelor of Science in Nursing
BUN- Blood Urea Nitrogen

C
C & S- Culture and Sensitivity Test (for bacteria)
Ca- Calcium
CA- Carcinoma
CAD- Coronary Artery Disease
CANDA- Computer-Assisted New Drug Application
CAPLA- Computer-Assisted Product License Application
CAPRA- Canadian Association of Pharmaceutical Regulatory Affairs
CBC- Complete Blood Count
CBCTN- Community-Based Clinical Trials Network
CBER- Center for Biologics Evaluation and Research (FDA)
CBF- Cerebral Blood Flow
CC- Chief Complaint
CDD- Canadian Drugs Directorate
CCRA- Certified Clinical Research Associate
CCRC- Certified Clinical Research Coordinator
CDC- Centers for Disease Control
CDER- Center for Drug Evaluation and Research (FDA)
CDRH- Center for Devices and Radiological Health (FDA)
CEN- Committee for European Normalization
CEU- Continuing Education Units
CFR- Code of Federal Regulations
CFSAN- Center of Food Safety and Applied Nutrition (FDA)
CHD- Coronary Heart DiseaseResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
CHF- Congestive Heart Failure
CHI- Closed Head Injury
CIOMS- Council for International Organizations of Medical Sciences (postapproval international ADR)
CIR- Cosmetic Ingredient Review (FDA)
CK or CPK- Serum Creatine Kinase or Creatine Phosphokinase
Cl- Serum or Plasma Chloride
CLIA- Clinical Laboratory Improvement Amendments
CMC- Chemistry and Manufacturing Controls (FDA)
CMDRH- Center for Medical Devices and Radiological Health (FDA)
CME- Continuing Medical Education
CMG- Cystometrogram
CNS- Central Nervous System
COSTART- Coding Symbols for Thesaurus of Adverse Reaction Terms (FDA)
CP- Compliance Program (FDA)
CPMP- Committee for Proprietary Medicinal Products
CPR- Cardiopulmonary Resuscitation
CPSC- Consumer Product Safety Commission
CRA- Clinical Research Associate
CRADA- Cooperative Research and Development Agreements (between
government agencies and industry)
CRC- Clinical Research Coordinator
CRF- Case Report Form
CRO- Clinical Research Organization
CSDD- Center for the Study of Drug Development
CSF- Cerebral Spinal Fluid
CSM- Commission on Safety of Medicines (United Kingdom)
CT- Clinical TrialResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
CT- Computed Tomography
CTM- Clinical Trail Material
CV- Curriculum Vitae
CVA- Cerebrovascular Accident
CVM- Center for Veterinary Medicine (FDA)
CXR- Chest X-Ray

D
DAWN- Drug Abuse Warning Network
DB- Double Blind
DBM- Division of Bioresearch Monitoring, CDRH, FDA
DCF- Data Correction Form/Data Clarification Form
DD- Department of Drugs (Sweden's equivalent to the FDA)
DEA- Drug Enforcement Administration (law enforcement division of FDA)
DEN- Drug Experience Network
DHHS-  Department of Health & Human Services
DIA- Drug Information Association
DJD- Degenerative Joint Disease
dl.- Deciliter
DNR- Do Not Resuscitate
DOD- Department of Defense
DOT- Department of Transportation
DPC-PTR Drug Price Competition and Patent Term Restoration Act of 1984
DRG- Diagnosis-Related Groups
DSI- Division of Scientific Investigations (FDA)
DSM- Diagnostic and Statistical Manual
DUR- Drug Use Review
Dx- Diagnosis

E
EAB- Ethical Advisory Board (similar to IRB, used by other nations)Research Coordinator Orientation, University of Pittsburgh, 2011                                                                                
ECG- Electrocardiogram
ECU- European Currency Unit
ED- Erectile Dysfunction
EEC- European Economic Community
EEG- Electroencephalogram
EFPIA- European Federation of Pharmaceutical Industries and Associations
EFTA- European Free Trade Association
EIR- Establishment Inspection Report (provides a detailed account of the FDA inspection)
EKG- Electrocardiogram
ELA- Establishment License Application
EMG- Electromyogram
EMS- Electronic Mail Service
ENDA- Electronic NDA
ENT- Ear, Nose, and Throat
EO- Executive Order
EORTC- European Organization for Research and Treatment of Cancer
EOS- End of Study
EPA- Environmental Protection Agency
EPI- Expanded Programme in Immunization (WHO program)
EPL- Effective Patent Life
ETT- Exercise Tolerance Test
EUP- Experimental Use Permit (for animal research, obtained from EPA)
EURODIAB- European Concerted Action on the Epidemiology of Diabetes

F
FACA- Federal Advisory Committee Act, 1972
FAX- Facsimile
FBS- Fasting Blood SugarResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
FCC- Federal Communications Commission
FCCSET- Federal Coordinating Council for Science, Engineering and Technology
FDA- Food and Drug Administration
FDA-482 Notice of Inspection
FDA-483 Notice of Adverse Findings in an Inspection
FDA-1572 FDA Form for Statement of Investigator
FDA-SRS Spontaneous Reporting System of the FDA
FDCA- Food, Drug, and Cosmetic Act
FDLI- Food and Drug Law Institute
FMD- Field Management Directives (FDA)
FOIA- Freedom of Information Act
FP- Family Practice
FR- Federal Register
FSIS- Food Safety and Inspection Service (USDA)
FTC- Federal Trade Commission (has primary responsibility for nonprescription advertising while the FDA has responsibility for prescription drug advertising)
FUO- Fever of unknown origin
Fx- Fracture

G
g- Gram
GAO- General Accounting Office
GATT- General Agreement of Tariffs and Trade
GCP- Good Clinical Practices
GFR- Glomerular Filtration Rate
GI- Gastrointestinal
GIB- Gastrointestinal Bleed
GLP- Good Laboratory Practice
GMP- Good Manufacturing PracticeResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
GP- General Practice Physician
GRAS- Generally Recognized as Safe (salt, hydrogen peroxide, etc.)
GRE- Generally Recognized as Effective
GTN- Nitroglycerin
GU- Genitourinary

H
HAI- Health Action International
HAZCOM- Hazardous Communication (EPA)
HAZMAT- Hazardous Materials (EPA)
Hb- Hemoglobin
HCFA- Health Care Financing Administration
HCO3- Serum or Plasma Bicarbonate
Hct- Hematocrit
Hg- Mercury
Hgb- Hemoglobin
HHS- Health and Human Services (Department of )
HIV- Human Immunodeficiency Virus
HMO- Health Maintenance Organization
HPB- Health Protection Branch (Canada's equivalent to the FDA)
HRG- Health Research Group
HRRC- Human Research Review Committee
HRSA- Health Resources and Services Administration
HS- At Hour of Sleep
HTN- Hypertension
Hx- History

I
IACUC- Institutional Animal Care and Use Committee (IRB for animal research)
IB- Investigator's Brochure
ICD9- International Classification of Disease Codes, 9th RevisionResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
ICD-9-CM International Classification of Disease Codes, 9th Revision-Clinical Modification
ICH- International Conference on Harmonisation
ICTH- International Committee on Thrombosis and Haemostases
ID- Identification or Intradermal
IDB- Investigational Drug Brochure
IDE- Investigational Device Exemption
IDR- Idiosyncratic Drug Reaction
IM- Internal Medicine or Intramuscular
INAD- Investigational New Animal Drug (FDA)
IND- Investigational New Drug (Application)
IPCS- International Program for Chemical Safety
IPEMC- International Commission for Protection Against Mutagens and Carcinogens
IPRA- International Product Registration Application
IPRD- International Product Registration Document
IRB- Institutional Review Board
IRG- Initial Review Groups
ISO- International Organization for Standardization
ISPE- International Society for Pharmacoepidemiology
IT- Information Technology
IV- Intravenous
IVD- In Vitro Diagnostic (test that works on a body fluid sample)
IVDA- Intravenous Drug Abuse
IVF- In Vitro Fertilization
IVF/ET- In Vitro Fertilization/Embryo Transfer
IVP- Intravenous Pyelography

J
JCAHO- Joint Commission on Accreditation of Healthcare OrganizationsResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
JCPT- Journal of Clinical Pharmacology and Therapeutics
JCRDD- Journal of Clinical Research and Drug Development
JCRP- Journal of Clinical Research and Pharmacoepidemiology
JPMA- Japan Pharmaceutical Manufacturers Association

K
K- Serum or Plasma Potassium
kg- Kilogram
Kilo- Kilogram
KS- Kaposi's sarcoma

L
LASER- Light Amplification by Stimulated Emission of Radiation
lb- Pound
LD- Linked Databases
LDH- Lactate Dehydrogenase
LOA- Letter of Agreement
LOC- Level of Concern
LTF- Liver Function Tests

M
MCA- Medicines Control Agency (a division of United Kingdom's equivalent to the FDA)
MCV- Mean Corpuscular Volume
MD- Medicines Division (United Kingdom's equivalent to the FDA)
MDD- Manic Depressive Disorder
MDI- Metered Dose Inhaler
MDR- Medical Device Reporting
MEDLARS- Medical Literature Analysis and Retrieval System
MHW- Ministry of Health and Welfare (Japan's equivalent to the FDA)
ml- Milliliter
mm- Millimeter
MMSE- Mini-Mental Status Exam (Folstein Test)Research Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
MOU- Memoranda of Understanding
MRA- Medical Research Associate
MRI- Magnetic Resonance Imaging
MS- Multiple Sclerosis
MTD- Maximum Tolerated Dose
MVP- Mitral Valve Prolapse

N
Na- Serum or Plasma Sodium
NA- Not Available, Not Applicable
NACH- National Advisory Health Council
NAF- Notice of Adverse Findings (post-FDA audit letter)
NAI- No Action Indication (most favorable post-FDA inspection classification)
NAS-NRC- National Academy of Sciences - National Research Council
NCE- New Chemical Entity
NCHS- National Center for Health Statistics (part of CDC)
NCI- National Cancer Institute
NCS- Not Clinically Significant
NCTR- National Center for Toxicological Research (FDA)
NCV- Nerve Conduction Velocities
NCVIA- National Childhood Vaccine Injury Act (1986)
ND- Not Done
NDA- New Drug Application
NDS- New Drug Study (Canada's equivalent of NDA)
NHLBI- National Heart, Lung, and Blood Institute
NHW- National Health and Welfare Department (Canada's equivalent of DHHS)
NIAID- National Institute of Allergy and Infections Disease
NIDA- National Institute of Drug Abuse
NIH- National Institutes of HealthResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
NKA- No Known Allergies
NLEA- Nutrition Labeling and Education Act (1990)
NME- New Molecular Entity
NMR- Nuclear Magnetic Resonance
NPI- Neuropsychiatric Inventory
NPO- Nothing By Mouth
NRB- Non-Institutional Review Board
NRC- Nuclear Regulatory Commission
NS- Not Clinically Significant
NSAID- Nonsteroidal Anti-Inflammatory Drug
NSR- Normal Sinus Rhythm
NTP- National Toxicology Program

O
OAI- Official Action Indicated (serious post-FDA inspection classification)
OB-GYN- Obstetrics-Gynecology
OBRR- Office of Blood Research and Review (FDA)
C- Temperature in Centigrade
OD- Right Eye
ODB- Observational Database
ODE- Office of Drug Evaluation (in FDA's CDER)
OE- Office of Enforcement (FDA)
OECD- Organization for Economic Cooperation and Development (international)
F- Temperature in Fahrenheit
OGD- Office of Generic Drugs (FDA)
OHA- Office of Health Affairs (FDA)
OHRP- Office for Human Research Protections
OMB- Office of Management and Budget
OPD/SC- Office of Professional Development and Staff College (FDA)Research Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
ORA- Office of Regulatory Affairs (FDA)
ORO- Office of Regional Operations (FDA)
OS- Left Eye
Os- Opening
OSHA- Occupational Safety and Health Administration
OTA- Office of Technology Assessment (part of Patents and Trademarks)
OTC- Over-the-Counter (nonprescription drugs)
OU- Both Eyes
Oz- Ounce

P
PA- Posterior-Anterior
PaCO2- Arterial CO2
PaO2- Arterial O2
PAR- Post-Approval Research (significant for approval of AIDS drugs)
PCC- Poison Control Center
PCP- Pneumocystis Carinii Pneumonia
PD- Parkinson’s Disease
PD- Pharmacodynamics
PDQ- Physician's Data Query (NCI-sponsored cancer trial registry)
PDR- Physician's Desk Reference
PE- Physical Examination or Pulmonary Embolus
PET- Positron Emission Topography
PFT- Pulmonary Function Tests
PhRMA- Pharmaceutical Research and Manufacturers of America
PHS- Public Health Service
PI- Package Insert
PI- Principal Investigator
PID- Pelvic Inflammatory DiseaseResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                
PK- Pharmacokinetics
PLA- Product License Application (when seeking commercialization of a biologic)
PMA- Pre-Market Approval (when seeking commercialization of a device)
PMI- Point of Maximum Impulse
PMS- Premenstrual Syndrome
PMS- Post-Marketing Surveillance
PO- By Mouth
PPE- Personal Protective Equipment (EPA)
PPI- Patient Package Inserts
PPO- Policy and Procedure Order
PPO- Preferred Provider Organization
PR- Pulse Rate
PR- interval An ECG interval
PRIM &R- Public Responsibility in Medicine and Research (nonprofit agency)
PRN- As Needed
PT- Prothrombin Time
PTT- Partial Thromboplastin Time
PUD- Peptic Ulcer Disease
PVD- Peripheral Vascular Disease

Q
QA- Quality Assurance
QAU- Quality Assurance Unit
QC- Quality Control
QD- Every Day
QI- Quality Improvement
QID- Four Times a DayResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
QNS- Quantity Not Sufficient
QOD- Every Other Day
QOL- Quality of Life

R
R & D- Research and Development
RADAR- Risk Assessment of Drugs - Analysis and Response
RAPS- Regulatory Affairs Professional Society
RBC- Red Blood Count
RCT- Randomized Controlled Trial
RDE- Remote Data Entry
RDRC- Radioactive Drug Research Committee
RIND- Reversible Inschemic Neurological Deficit
RL- Regulatory Letter (post-FDA audit letter)
RUG- Resource Utilization Group
Rx- Prescription

S
SAE- Serious Adverse Event
SAH- Subarchnoid Hemorrhage
SC- or SQ Subcutaneous
SC- Study Coordinator
SD- Source Document
SD- Standard Deviation
SDAT- Senile Dementia of the Alzheimer's Type
SE- Standard Error
SEA- Single European Act of 1987
SEER- Surveillance, Epidemiology, and End Results (Registry of NCI)
SMDA- Safe Medical Devices Act (1990)
SME- Significant Medical Event
SMO- Site Management OrganizationResearch Coordinator Orientation, University of Pittsburgh, 2011                                                                                  
SNDA- Supplemental NDA
SOB- Shortness of Breath
SOP- Standard Operating Procedure
SSM- Skin Surface Microscopy
STD- Sexually Transmitted Disease
STT- Short Term Tests
SUD- Sudden Unexpected Death
Sx- Symptom

T
TIA- Transient Ischemic Attack
TID- Three Times a Day
TIND- Treatment IND
TK- Toxicokinetics
TMO- Trial Management Organization
TNG- Nitroglycerin
TQM- Total Quality Management

U
UA- Urinalysis
UKCCR- United Kingdom Coordinating Committee on Cancer Research
UNESCO- United Nations Educational Science and Cultural Organization
UNK- Unknown
URI- Upper Respiratory Infection
USDA- United States Department of Agriculture
USP- U.S. Pharmacopeia
UTI- Urinary Tract Infection
VA- United States Department of Veterans Affairs
VAI- Voluntary Action Indicated (post-FDA audit inspection classification)
VER- Visual Evoked Response
VS- Vital SignsResearch Coordinator Orientation, University of Pittsburgh, 2011

W                                                                                  
WBC- White Blood Count
WHO- World Health Organization
WL- Warning Letter (most serious of post-FDA audit letter, demands immediate action within 15 days)
WNL- Within Normal Limits

2 comments:

  1. Hi Kaushik, thanks for your entry. I will update the list..Thank you once again.

    ReplyDelete

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