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Sunday, February 12, 2012
Unknown
- e-Book: 784 pages
- Publisher: Wiley; 2 edition (January 16, 2007)
- Language: English
- ISBN-10: 0470010142
- ISBN-13: 978-0470010143
Showing posts with label Clinical Research. Show all posts
Showing posts with label Clinical Research. Show all posts
Sunday, February 12, 2012
Handbook of clinical trials free downlaod
Evaluating clinical research free download
- e-Book: 170 pages
- Publisher: Springer; 2nd edition (August 2, 2007)
- Language: English
- ISBN-10: 0387728988
- ISBN-13: 978-0387728988
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
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
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
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
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
Monday, September 12, 2011
Free download of Essential of Clinical Research
Download link: (Free download of Essential of Clinical Research) If it is not working please let me now
http://uploading.com/files/ee2ad196/Essentials%2Bof%2BClinical%2BResearch.pdf/
Thursday, June 23, 2011
Clinical trials Steps
Phase I: Initial Pharmacological Evaluation. Determines the safe dosage level for humans. The medication is given to volunteers at gradual doses. The first sign of toxicity is noted. Dosage levels below the toxic dose level are considered safe.
• Phase II: Limited Controlled Evaluation. Determines the therapeutic range for humans. Volunteers who have the disease or disorder are given the medication at gradual doses and are examined to determine the dose that provides the therapeutic effect.
• Phase III: Extended Clinical Evaluation. Determines the effects of the medication on a large group of patients who have the disease or disorder. If the medication proves effective, then the pharmaceutical manufacturer submits a New Drug Application (NDA) to the Food and Drug Administration for approval to market the medication.
• Phase IV: Post Marketing Surveillance Trial. Determines ongoing safety of the medication after the medication is being prescribed by healthcare providers.
Posted in: Clinical Research
Tuesday, June 21, 2011
Clinical trial endpoints.
Whenever clinical study results are publicly announced, the endpoints are the focus; more specifically, the focus is on whether the clinical trial met or failed its primary endpoint. Clinical trial endpoints are important because they are proof that the drug does what its manufacturer claims it does for the patient. Even though clinical trial endpoints are measurements at an individual patient level, the results are extrapolated to entire populations of patients based on clinical similarities to patients in the clinical trials. The Food and Drug Administration bases approval decisions on clinical trial endpoints.
The most important requirement for a clinical trial endpoint is clinical relevance, or what the effect means to the patient. Appropriate measurement or detection of a clinical endpoint is secondary to the appropriate selection of a clinically relevant endpoint; measuring an endpoint well means nothing to the patient if the endpoint has poor clinical relevance. In addition to clinical relevance, trial endpoints should reflect the research question, the drug's mechanism (or mechanisms) of action and patient well-being. In phase I clinical studies, safety is the primary endpoint; in phase II clinical studies, a measure of efficacy is the primary endpoint. Quality of life (QOL) is becoming an increasingly important endpoint in chronic or terminal conditions, including cancer.
Clinical trials should have only one primary endpoint -- hence the "primary" designation. The primary endpoint should be the most meaningful result in a clinical trial. An example of a primary endpoint in cancer clinical trials is survival. Survival has long been considered the "gold standard" endpoint for cancer therapies, based on the importance of survival to cancer patients. Other results that contribute to the interpretation of the clinical trial are then considered "secondary endpoints." A clinical trial can have, and often does have, many secondary endpoints. Still, when a clinical trial attempts to capture too many endpoints, complications can arise that impede the critical goal of answering a primary question. If multiple endpoints yield conflicting results, the study cannot be interpreted meaningfully. Multiple endpoints also increase the chance of a Type 1 error (when a difference is shown when there is no actual difference).
Posted in: Clinical Research
