abbreviations in Clinical Research

ACRP                          Association of Clinical Research Associates
ADR                            Adverse Drug Reaction
AE                               Adverse Event
AMA                           American Medical Association
CCRC                         Certified Clinical Research Coordinator
CCRP                          Certified Clinical Research Professional
CDC                            Center for Disease Control
CDER                          Center for Drug Evaluation and Research
CEU                            Continuing Education Unit
COI                             Conflict of Interest
CRC                            Clinical Research Coordinator
CFR                             US Code of Federal Regulations
CLIA                           Clinical Laboratory Improvement
CRA                            Clinical Research Associate (Monitor)
CRF                             Case Report Form
CRO                            Contract Research Organization
CRSC                          Clinical Research Staff Council
CTC                            Clinical Trials Center
CTSS                          Clinical Trials Support Services
DCF                            Data Clarification Form
DGR                            Dangerous Goods Regulation
D & H                          Doctor and Hospital Account
DHHS                          US Department of Health and Human Services
DOD                            US Department of Defense
DSMB                         Data Safety Monitoring Board
EDC                            Electronic Data Capture
EMR                            Electronic Medical Record
FDA                            US Food & Drug Administration
FWA                           Federal Wide Assurance
GCP                            Good Clinical Practice
GCRC                         General Clinical Research Center (often referred to as CRC)
GLP                             Good Lab Practice
GMP                            Good Manufacturing Practice
HIPAA                        Health Insurance Portability and Accessibility Act
HSRC                          Human Subjects Radiation Committee
IATA                           International Air Transport Association
IB                                Investigator’s Brochure
ICD or ICF                  Informed Consent Form
ICH                             International Conference of Harmonization
IDE                              Investigational Device Exemption
IND                             Investigational New Drug
IRB                              Institutional Review Board
LAN                            Local Area Network
MAB                           Medical Arts Building
MCN                           Medical Center North
MOP                           Manual of Operations
MPA                            Multiple Project Assurances
MTD                            Maximum Tolerated Dose
NAI                             No Action Indicated
NCS                            Not Clinically Significant
NDA                            New Drug Application
NIH                             National Institute of Health
OAI                             Official Action Indicated
OHRP                          Office of Human Research Protections
ORI                             Office of Research Integrity
OTC                            Over the Counter
PHI                              Protected Health Information
PHS                             Public Health Service
PCRO                          Pediatric Clinical Research Office
PI                                 Principle Investigator
PM                              Project Manager
PMS                            Post Marketing Surveillance
PRB                             Preston Research Building
RCR                            Responsible Conduct of Research
RRB                             Robinson Research Building
RDE                             Remote Data Entry
RSS                             Research Support Services
QA                              Quality Assurance
QC                              Quality Control
SAE                             Serious Adverse Event
SD                               Source Document
SI                                 Sub Investigator
SIV                              Site Initiation Visit
SMO                           Site Management Organization
SoCRA                        Society of Clinical Research Associates
SOP                             Standard Operating Procedures
VAI                             Voluntary Action Indicated
VTEU                          Vaccine Trial Evaluation Unit
WHO                           World Health Organization

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