Acronyms
ACRP
|
Association of Clinical Research Professionals
|
ADR
|
Adverse Drug Reaction
|
AE
|
Adverse Event
|
AMA
|
American Medical Association
|
BIMO
|
Bioresearch Monitoring Program
|
CCI
|
Certified Clinical Investigator
|
CCRC
|
Certified Clinical Research Coordinator
|
CCRI
|
Certified Clinical Research Investigator
|
CDER
|
Center for Drug Evaluation and Research
|
CFR
|
Code of Federal Regulations
|
CI
|
Clinical Investigator
|
CPGM
|
Compliance Program Guidance Manual
|
CRA
|
Clinical Research Associate
|
CRC
|
Clinical Research Coordinator
|
CRF
|
Case Report Form
|
CRO
|
Clinical Research Organization
|
CV
|
Curriculum itae
|
DHHS
|
Department of Health and Human Services
|
DIA
|
Drug Information Association
|
DGR
|
Dangerous Goods Regulation
|
ECG
|
Electrocardiogram
|
EDC
|
Electronic Data Capture
|
EIR
|
Established Inspection Report
|
FDA
|
Food and Drug Administration
|
FDAMA
|
FDA Modernization Act
|
GCP
|
Good Clinical Practice
|
GLP
|
Good Laboratory Practice
|
GMP
|
Good Manufacturing Practices
|
HAM-A
|
Hamilton Rating Scale for Anxiety
|
HIPAA
|
Health Insurance Portability and Accountability Act
|
HHS
|
Health and Human Services
|
IATA
|
International Air Transport Association
|
IC
|
Informed Consent
|
ICH
|
International Conference on Harmonization
|
IEC
|
Independent Ethics Committee
|
IND
|
Investigational New Drug application
|
IRB
|
Institutional Review Board
|
IV
|
Intravenously
|
NAI
|
No Action Indicated
|
NDA
|
New Drug Application
|
NIH
|
National Institutes of Health
|
OAI
|
Official Action Indicated
|
OCR
|
Office of Civil Rights
|
OTC
|
Over-the-Counter
|
PA
|
Physician Assistant
|
PDUFA
|
Prescription Drug User Fee Act
|
PhRMA
|
Pharmaceutical Research and Manufactures of America
|
PHI
|
Protected Health Information
|
PI
|
Principal Investigator
|
PM
|
Project Manager
|
PMS
|
Post Marketing Surveillance
|
QA
|
Quality Assurance
|
RDE
|
Remote Data Entry
|
SAE
|
Serious Adverse Event
|
SC
|
Study Coordinator
|
SI
|
Sub-Investigator
|
SMO
|
Site Management Organization
|
SoCRA
|
Society of Clinical Research Associates
|
SOP
|
Standard Operating Procedure
|
Sub-I
|
Sub-Investigator
|
VAI
|
Voluntary Action Indicated
|
GLOSSARY
Adverse Drug Reaction
An unintended reaction to a drug taken at normal doses
Adverse Event (AE)
An untoward medical occurrence in a study subject administered a pharmaceutical product; it does not necessarily have a causal relationship with this treatment.
Beneficence
Doing no harm. Maximizing benefits while minimizing risks.
Biologic
A virus, vaccine, toxin, antitoxin, blood product, therapeutic serum or similar material for the prevention, treatment or cure of disease or injury in humans.
Biotechnology
Any technique that uses living organisms or substances from living organisms, biological systems or processes to make or modify a product or process, to change plants or animals, or to develop microorganisms for specific use.
Blinding
The process through which study subjects, the investigator and/or other involved parties in a clinical trial are kept unaware of the treatment assignments of study subjects.
Case Report Form (CRF)
A record of pertinent information collected on each subject during a clinical trial, based on the protocol.
Certified Clinical Investigator
A clinical investigator who meets required experience and educational levels and has earned certification by passing an exam.
Certified Clinical Research Coordinator (CCRC)
CRC with more than two years experience and certification earned by passing an exam.
Clinical Trial (Clinical Study, Clinical Investigation)
Any experiment that involves a test article (drug, device, biologic) and one or more human subjects.
Clinical Research Associate (CRA)
The sponsor monitor who visits sites periodically during a study to monitor the data and assess progress.
Clinical Research Coordinator (CRC) (Study Coordinator)
The person at an investigational site who manages the daily operations of a clinical investigation and who is responsible to the investigator.
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