Clinical Research Support

Acronyms

A

AAHRPP - Association for the Accreditation of Human Research Protection Programs

ABMDR - American Bone Marrow Donor Registry

ACRP - Association of Clinical Research Professionals

AE - Adverse Event

ALCOA - Attributable, Legible, Contemporaneous, Original, Accurate

 

B

BIMO - Bioresearch Monitoring Program

Biologic - Any virus, therapeutic serum, toxin, antitoxin or analogous product applicable to the prevention, treatment or cure of diseases or injuries in man.

BLA - Biologics License Application

 

C

CBER - Center for Biologics Evaluation and Research

CC-CTW - Cancer Consortium, Clinical Trials Websites - publicly available websites that provide a searchable format of research studies in progress at the Cancer Consortium

CC-IRB - Cancer Consortium IRB

CCO - Clinical Coordinator Office

CDER - Center for Drug Evaluation and Research

CDRH - Center for Devices and Radiological Health

CFR - Code of Federal Regulations

cGMP - Current Good Manufacturing Practices

cGTP - Current Good Tissue Practices

CIS - Clinical Information Systems

CLIA - Clinical Laboratory Improvement Amendments

Clinical Hold - FDA order to delay proposed clinical investigation or to suspend an ongoing investigation

ClinicalTrials.gov - www.clinicaltrials.gov

CMC - Chemistry, Manufacturing and Controls

CORE - Clinical Oncology Research Entrance - Website that houses a number of study-related web tools including Clinical FYI

CR - Complete Remission, Response

CRA - Clinical Research Associate

CRBB - Clinical Research Budget and Billing Support

CRC - Clinical Research Coordinator

CRD - FHCRC Clinical Research Division

CRF - Case Report Form

CRO - Contract Research Organization

CROC - Clinical Research Oversight Committee

CRR - Continuation Review Report

CTC - Common Terminology Criteria for Adverse Events published by the Cancer Therapy Evaluation Program

CTI - Clinical Trials Implementation committee reviews general oncology clinical trials prior to the clinical trial opening at the SCCA

CTRP - Clinical Trials Reporting Program

 

D

DFS - Disease Free Survival

DHHS - Department of Health and Human Services

DLI - Donor Lymphocyte Infusion

DLT - Dose Limiting Toxicity

DMF - Drug Master File

Drug - Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man

Drug Product - A finished dosage form (e.g., tablet, capsule, solution) that contains an active drug ingredient

Drug Substance - Any substance or mixture of substances, when used in the production of a drug, becomes an active ingredient of the drug product

DSMB - Data and Safety Monitoring Board

DSMC - Data and Safety Monitoring Committee


E

EC - Ethics Committee or European Community

EPSAC - External Performance Site Assessment Committee - Reviews certain multi-center trials

EU - European Union

 

F

FDA - Food and Drug Administration

FDA Form 1571 - Investigational New Drug Application

FDA Form 1572 - Statement of Investigator

FDA Form 3500A - MedWatch (FDA Safety Information and Adverse Event Reporting Program) MANDATORY Reporting (Note This is NOT the same as FDA Form 3500, which is used for VOLUNTARY reporting.)

FDA Form 3674 - Certification of Compliance with Requirements of ClinicalTrials.gov Data Bank

FDA Form 483 - Inspectional Observations (This may be issued by FDA at the conclusion of an inspection)

FHCRC - Fred Hutchinson Cancer Research Center

FR - Federal Register

FWA - Federal Wide Assurance

FYI (Clinical FYI) - CORE web application that delivers current study documents to clinic and research staff

 

G

GCA - Grants and Contracts Administration

GCP - Good Clinical Practice

GCRC - General Clinical Research Center

GLP - Good Laboratory Practice

Guidance - Documents published by FDA to provide interpretation of regulations

 

H

HHS - Health and Human Services

HIM - Health Information Management

HIPAA - Health Insurance Portability and Accountability Act

HRPP - Human Research Protection Program

HSC - Human Subjects Committee

HSD - Human Subjects Division

 

I

IB - Investigator Brochure

IBC - Institutional Biosafety Committee

IBMTR - International Bone Marrow Transplant Registry

IC - Informed Consent

ICF - Informed Consent Form

ICH - International Conference on Harmonization

IDE - Investigational Device Exemption – the application process a new medical device goes through for FDA approval

IDS - Investigational Drug Services

IEC - Independent Ethics Committee

IND - Investigational New Drug – the application process a new drug goes through for FDA approval

IRB - Institutional Review Board - Committee that reviews research to protect the rights and welfare of research participants

IRO - Institutional Review Office - Office at FHCRC that administers the Cancer Consortium IRB Committees as well as the FHCRC IACUC Committee

 

L

LOA - Letter of Authorization

LTFU - Long-Term Follow-Up

 

M

MTD - Maximum Tolerated Dose

MUR - Matched Unrelated Donor

 

N

NCI - National Cancer Institute

NDA - New Drug Application

NMDP - National Marrow Donor Program

 

O

OGC - Office of General Counsel

OHRP - Office for Human Research Protection

OPD - Outpatient Department

ORA - Office of Regulatory Affairs (FDA)

ORCA - Online Record of Clinical Activity

 

P

PA - Physician Assistant

PATS - Protocol Accrual Tracking System - CORE web application for tracking participant accrual on clinical trials

PHS - FHCRC Public Health Sciences

PI - Principal Investigator or Package Insert (approved product labeling)

PIM - Protocol Implementation Committee - provides a forum for the discussion of implementation and operational needs of newly developed Blood and Marrow Transplant (BMT) clinical research protocols to occur at SCCA, UWMC and SCH

PIRO - Professional Institutional Review Operations - Database used by the Cancer Consortium to track research studies

PPOC - Patient Protection Oversight Committee

PR - Partial Response

PRC - Protocol Review Coordinator - Manages the review process for certain groups of Cancer Consortium trials

PRMS - Protocol Review & Monitoring System - mandated by NCI because of the Cancer Consortium's status as a comprehensive cancer center

 

Q

QA - Quality Assurance

QC - Quality Control

QoL - Quality of Life

 

R

RIO - SCCA Research Implementation Office

RTS - Research Testing Services

 

S

SAE - Serious Adverse Event

SC - Seattle Children’s

SCCA - Seattle Cancer Care Alliance

SCRI - Seattle Children's Research Institute

SOCRA - Society of Clinical Research Associates

SOP - Standard Operating Procedure

SPC - Standard Practice Committee

Sponsor - A company, person, organization or institution that takes responsibility for initiating, managing or financing a clinical trial

SRC - Scientific Review Committee - part of the PRMS that reviews new submissions and modifications

SWOG - Southwest Oncology Group

 

U

URD - Unrelated Donor

USP - US Pharmacopeia

UW - University of Washington

UWMC - University of Washington Medical Center

 

V

VA - Veterans Affairs

VIDD - FHCRC Vaccine and Infectious Disease Division

 

W

WHO - World Health Organization

WIRB - Western IRB

 

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