Contract Research Organization

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Acronym      DESCRIPTION
ACOSOG       American College of Surgeons Oncology Group
ADE          Adverse Drug Event
AdEERS       Adverse Event Expedited Reporting System-Investigation Agents-CTEP
ADR          Adverse Drug Reaction
AE           Adverse Event
AI           Associate Investigator
CALGB        Cancer and Acute Leukemia Group B
CBER         Center for Biologics Evaluation and Research-FDA
CC           Clinical Research Center-NIH
CCR          Center for Cancer Research
CDC          Center for Disease Control and Prevention
CDER         Center for Drug Evaluation and Research - FDA
CDUS         Clinical Data Update System-Electronic Data system CTEP
CFR          Code of Federal Regulations
CIB          Clinical Investigations Branch
CIS          Cancer Information Service
CIT          Center for Information Technology
COG          Children's Oncology Group
CRF          Case Report Form
CRO          Contract Research Organization
CSR          Center for Scientific Review
CTC          Common Toxicity Criteria version 2.0
CTCAE        Common Terminology Criteria for Adverse Events version 3.0
CTD          Common Technical Document
CTEP         Cancer Therapy Evaluation Program-DCTD-NCI
CTMS         Clinical Trials Monitoring Service- CTEP
DARF         Drug Accountability Record Forms-Investigational Agents
DCB          Division of Cancer Biology-NCI
DCCPS        Division of Cancer Control and Population Sciences-NCI
DCEG         Division of Cancer Epidemiology and Genetics
DCP          Division of Cancer Prevention-NCI
DCTD         Division of Cancer Treatment and Diagnosis-NCI
DEA          Division of Extramural Activities-NCI
DEC          Deputy Ethics Counselor
DHHS         Department of Health and Human Services
DSMB/DSMC    Data Safety Monitoring Board/Committee
ECOG         Eastern Cooperative Oncology Group
EMMES        Contractor - NCI
ETIB         Experimental Transplant and Immunology Branch-CCR
FDA          Food and Drug Administration
FIC          John E. Fogarty International Center
FWA          Federal Wide Assurance - OHRP
GCP          Good Clinical Practice-International Conference on Harmonization-ICH-GCP
GOC          Gynecologic Oncology Group
HHS          Health and Human Services
HRDD         Human Resource Development Division
HRSA         Health Resources and Services Administration
HTSC         Harris Technical Services Corp, Contractor-NCI
IBC          Institutional Biosafety Committee
ICH          International Conference on Harmonization
IDB          Investigational Drug Branch
IDE          Investigational Device Exemption
IND          Investigational New Drug
IRB          Institutional Review Board
LOI          Letter of Intent

updated 37/13/06

Acronym      DESCRIPTION
MEDRA        Medical Terminology Coding System
MedWatch     Adverse Event Reporting System-voluntary and mandatory-FDA
MOB          Medical Oncology Branch-CCR
NCCAM        National Center for Complementary and Alternative Medicine
NCCTG        North Central Cancer Treatment Group
NCI          National Cancer Institute
NCIC-CTG     NCI of Canada Clinical Trials Group
NCI-FCRDC    NCI Frederick Cancer Research and Development Center
NCMHD        National Center on Minority Health and Health Disparities
NCRR         National Center for Research Resources
NDA          New Drug Application
NEI          National Eye Institute
NHGRI        National Human Genome Research Institute
NHLBI        National Heart, Lung, and Blood Institute
NIA          National Institute on Aging
NIAAA        National Institute on Alcohol Abuse and Alcoholism
NIAID        National Institute of Allergy and Infectious Disease
NIAMS        National Institute of Arthritis and Musculoskeletal and Skin Diseases
NIBIB        National Institute of Biomedical Imaging and Bioengineering
NICHD        National Institute of Child Health and Human Development
NIDA         National Institute on Drug Abuse
NIDCD        National Institute of Deafness and Other Communication Disorders
NIDCR        National Institute of Dental and Craniofacial Research
NIDDK        National Institute of Diabetes and Digestive and Kidney Diseases
NIEHS        National Institute of Environmental Health Sciences
NIGMS        National Institute of General Medical Sciences
NIH          National Institutes of Health
NIMH         National Institutes of Mental Health
NINDS        National Institute of Neurological Disorders and Strokes
NINR         National Institute of Nursing Research
NLM          National Library of Medicine.
NOB          Neuro-oncology Branch-CCR
NSABP        National Surgical Adjuvant Breast & Bowel Project
OBA          Office for Biologic Activity-NIH
OCD          Office of the Clinical Director-NIH, Institute specific
OD           Office of the Director
OER          Office of Extramural Research-NIH
OHRP         Office for Human Research Protection
OHSR         Office for Human Subjects Research-NIH
OIR          Office of Intramural Research-NIH
OPS          Office of Protocol Support-CC
ORI          Office of Research Integrity
PHS          Public Health Service
PI           Principal Investigator
PIO          Protocol and Information Office-CTEP
PMB          Pharmaceutical Management Branch-CTEP
POB          Pediatric Oncology Branch-CCR
PRC          Protocol Review Committee-CTEP
PRMC         Protocol Review and Monitoring Committee-CCR
PSU          Protocol Status Update- CTEP Form
PSW          Protocol Submission Worksheet-CTEP
RAB          Regulatory Affairs Branch
RAC          Recombinant DNA Advisory Committee
ROB          Radiation Oncology Branch-CCR
RSC          Radiation Safety Committee

updated 37/13/06

Acronym      DESCRIPTION
RTOG         Radiation Therapy Oncology Group
SACHRP       Secretary's Advisory Committee on Human Research Protections
SAE          Serious Adverse Event
SAIC         Science Applications International Corporation, Contractor - NIH
SB           Surgery Branch-CCR
SMO          Site Management Organization
SWOG         Southwest Oncology Group
THERADEX     Contract Research Organization-Clinical Trials Monitoring Service-CTEP
TRI          Technical Resources International, Contractor - NCI
UOB          Urologic Oncology Branch-CCR

updated 37/13/06

Description: Contract Research Organization document sample