Clinical Research Operations

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)

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 Transplantation 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

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

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