glossary of Abbreviations, Acronyms, and Terminology

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Term Definition
1572 Statement of Investigator (Form FDA 1572)
AACR American Association for Cancer Research
ABTC Adult Brain Tumor Consortium is a multi-institutional consortium created from the consolidation of two previous, separate NCI-funded consortia: New Approaches to Brain Tumor Therapy (NABTT) and North American Brain Tumor Consortium (NABTC). 
ACC Adenoid cystic carcinomas are tumors that most commonly originate in the salivary glands.
ACCRU Academic and Community Cancer Research United is a clinical research group based at the Mayo Clinic Cancer Center in Rochester, Minnesota. ACCRU includes a network of more than 50 academic and community-based cancer treatment clinics and hospitals in the United States and Canada. ACCRU, formerly known as the Mayo Clinic Cancer Research Consortium (MCCRC), was established in 2004 to conduct pharmaceutical industry-sponsored clinical trials to improve cancer treatment. The name was changed to ACCRU in late 2011, coinciding with the formation of the Alliance for Clinical Trials in Oncology.
ACOSOG American College of Surgeons Oncology Group, see Alliance.
ACR American College of Radiology
ACRIN American College of Radiology Imaging Network, see ECOG-ACRIN.
ACRP Association of Clinical Research Professionals was founded in 1976 to address the educational and networking needs of research nurses and others who support the work of clinical investigations.
ACS American Cancer Society
ACS CRP American College of Surgeons Clinical Research Program is one of the five Alliance programs.  ACS CRP works to reduce the impact of cancer by validating and disseminating strategies for its prevention and treatment.
AdEERS Adverse Event Expedited Reporting System is a retired NCI web-based system for submitting expedited reports for serious and/or unexpected events.
AE Adverse Event 
AIS Audit Information System
Alliance Alliance for Clinical Trials in Oncology is one of the five U.S. network groups of the NCI National Clinical Trials Network (NCTN) Program.  Alliance formed from the merger of American College of Surgeons Oncology Group (ACOSOG), Cancer and Leukemia Group B (CALGB), and North Central Cancer Treatment Group (NCCTG).
AML Acute myelogenous leukemia
ANFU Acceptable needs follow-up 
ASCII American Standard Code for Information Interchange
ASCO American Society of Clinical Oncology is a non-profit organization founded in 1964 with the overarching goals of improving cancer care and prevention. Nearly 30,000 oncology practitioners belong to ASCO, representing all oncology disciplines and subspecialties. Members include physicians and health-care professionals in all levels of the practice of oncology.
ASH American Society of Hematology is a professional society concerned with the causes and treatments of blood disorders. The mission of ASH is to further the understanding, diagnosis, treatment, and prevention of disorders affecting the blood, bone marrow, and the immunologic, hemostatic and vascular systems, by promoting research, clinical care, education, training, and advocacy in hematology.
ASTRO American Society for Radiation Oncology

 

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Term Definition
BC Breast cancer
BioMS Biospecimen Management System (BioMS) is an Alliance web-based application for logging and tracking shipment of patient biospecimens collected from any Alliance or legacy ACOSOG, CALGB, or NCCTG trial. It serves a similar function as the previous CALGB specimen tracking system (STS). BioMS provides access to a comprehensive inventory of all specimens collected across all Alliance group biorepositories. BioMS training materials, user manuals and FAQs are available on the BioMS Help Site.
BIQSFP Biomarker, Imaging and Quality of Life Studies Funding Program
BLA Biologic License Application
BSA Body surface area

 

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Term Definition
caAERS Cancer Adverse Event Reporting System
caBIG Cancer Biomedical Informatics Grid is an NCI initiative that is maintained by the Center for Biomedical Informatics and Information Technology (CBIIT). Launched in 2004, caBIG is an open source information network. Its mission is to enable secure data exchange throughout the cancer community.
caDSR Cancer Data Standards Registry and Repository is a database and set of APIs and tools to create, curate, and implement use of common data elements (CDEs) on case report forms (CRFs) in the cancer research community. These CDEs are developed by the NCI CBIITT and caBIG.
CALGB Cancer and Leukemia Group B, see Alliance
CAO Chief administrative officer
CAP College of American Pathologists
CAPA Corrective and Preventive Action
CAT Computer Axial Tomography
CBCTR Cooperative Breast Cancer Tissue Resource Database provides researchers with access to approximately 8,000 cases of formalin-fixed, paraffin-embedded primary breast cancer specimens, with associated clinical data. The collection is particularly well-suited for validation studies of diagnostic and prognostic markers. Funded by the NCI.
CC Colon cancer
CCOP Community Clinical Oncology Program is a network for conducting cancer prevention and treatment clinical trials by community physicians. This network connects academic centers (Research Bases who design and conduct the trials) with community physicians (CCOP, MB-CCOP who accrue patients to those trials), see NCORP.
CCP Cancer Control Program is one of the five Alliance programs.  CCP conducts innovative scientific studies, including interventional, methodological, and health policy research, to help reduce the incidence, morbidity and mortality of cancer in broad populations.
CCRA Certified Clinical Research Associate. Certification issued by ACRP.
CCRC Certified Clinical Research Coordinator. Certification issued by ACRP.
CCRP Certified Clinical Research Professional. Certification of coordinators, monitors, and other research professionals issued by SoCRA.
CDASH Clinical Data Acquisition Standards Harmonization is a content standard for the data elements that should be captured on a CRF.
CDC Centers for Disease Control and Prevention is a federal agency under the DHHS charged with protecting public health and safety.
CDEs Common data elements are standardized terms for the collection and exchange of data.
CDISC Clinical Data Interchange Standards Consortium
CEU Continuing Education Unit
CF Consent form
CFO Chief financial officer
CFR Code of Federal Regulations; usually cited by title and part. (Example: 21 CFR 211 is Title 21, Part 211.)
CHTN Cooperative Human Tissue Network is an NCI-funded resource that provides normal, benign, pre-cancerous and cancerous human tissue to the scientific community for basic and developmental studies in many areas of cancer research.
CIRB Central Institutional Review Board is a project sponsored by the NCI to facilitate and streamline the local IRB review for national multi-center cancer treatment trials.
CLIA Clinical Laboratory Improvement Amendments
CLL Chronic lymphocytic leukemia
CME Continuing Medical Education
CNS Central nervous system
CoC Commission on Cancer was established by the American College of Surgeons (ACoS).
COG Children's Oncology Group is one of the five U.S. network groups of the NCI National Clinical Trials Network (NCTN) Program. This group was formed in 2000 as a result of the merger of four groups: the Children's Cancer Study Group (CCG), Pediatric Oncology Group (POG), Intergroup Rhabdomyosarcoma Study Group (IRS), and the National Wilms Tumor Study Group (NWTS).
COI Conflict of Interest
CoP Community of Practice
COPRTRG Community Oncology and Prevention Trials Research Group
CP3R Cancer Program Practice Profile Reports are released by the Commission on Cancer (CoC).
CPOP Central Protocol Operations Program is one of the five Alliance programs. CPOP oversees the development, maintenance and distribution of all study protocols that are generated by Alliance scientific committees.
CR Complete Response
CRA Clinical Research Associate, see also CCRA.
CRADA Cooperative Research and Development Agreement
CRC Clinical Research Coordinator, see also CCRC.
CRF Case Report Form
CRO Clinical research organization
CRP Clinical Research Professional; also the name of an Alliance committee for all CRPs involved in data collection and research (e.g., CRAs, data managers/data coordinators, oncology nurses)
CSA Clinical Supply Agreement
CSF Cerebrospinal fluid
CT Computed Tomography
CTA Clinical Trial Agreement
CTC Common Toxicity Criteria is the precursor of what is today named the Common Terminology Criteria for Adverse Events (CTCAE). The original CTC was developed by the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) in 1983 to aid in the documentation and analysis of adverse effects of chemotherapy. CTC, like CTCAE, included terms and a severity grading scale with descriptions of the allowed grades of each term.
CTCAE Common Terminology Criteria for Adverse Events is a list of adverse event (AE) terms commonly encountered in oncology. Each AE term is defined and accompanied by a grading scale that indicates the severity of the AE. In CTCAE v4.0, the AE terms are organized by the System Organ Classes (SOCs) defined by the Medical Dictionary for Regulatory Activities (MedDRA). CTCAE has been developed from the earlier vocabulary known as CTC (Common Toxicity Criteria).
CTEP Cancer Therapy Evaluation Program is a program sponsored by the NCI, CTEP funds an extensive national program of cancer research and sponsors clinical trials to evaluate new anti-cancer agents, with a particular emphasis on translational research to elucidate molecular targets and mechanisms of drug effects.
CTEP-AERS CTEP Adverse Event Reporting System
CTEP-IAM Cancer Therapy Evaluation Program (CTEP) Identity and Access Management (IAM) is an application of the NCI that provides user accounts and access to Associates and Investigators participating in NCI-sponsored clinical trials. A CTEP-IAM user account is required to access the members’ area of the Alliance website, as well as CTSU, the Oncology Patient Enrollment Network (OPEN), and CTEP functions (e.g., AdEERS).
CTMB Clinical Trials Monitoring Branch
CTMS Clinical Trial Management System
CTRP Clinical Trials Reporting Program is a comprehensive database established by the NCI to collect regularly updated information, including accrual, on all NCI-supported clinical trials. This database of the entire NCI portfolio helps identify gaps in clinical research and duplicative studies, facilitates effective clinical trial prioritization, and enhances patient accrual to trials by making physicians aware of relevant opportunities for participation in clinical trials.
CTSU Clinical Trials Support Unit is a project sponsored by the NCI for the support of a national network of physicians to participate in NCI-sponsored Phase III cancer treatment trials. The majority of these trials are sponsored by NCTN adult groups.
CV Curriculum Vitae

 

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Term Definition
DARF Drug Accountability Record Form
dbGaP Database of Genotypes and Phenotypes
DCP Division of Cancer Prevention is a division of NCI dedicated to advancing biomedical science, strengthening preventive medicine, and improving public health.
DCTD Division of Cancer Treatment and Diagnosis 
DHHS Department of Health and Human Services is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The NIH is an operating division of DHHS. Also referred to as HHS.
DLT Dose-limiting toxicity
DNA Deoxyribonucleic acid
DSM Diagnostic and Statistical Manual (of the American Psychiatric Association)
DSMB Data Safety Monitoring Board of the Alliance formally monitors phase 3 and randomized phase 2 trials. The DSMB addresses issues of research participant protection and makes recommendations regarding the continuation, termination, or modification of studies.

 

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Term Definition
ECG Electrocardiogram
ECOG Eastern Cooperative Group. See ECOG-ACRIN.
ECOG-ACRIN ECOG-ACRIN Cancer Research Group is one of the five U.S. network groups of the NCI National Clinical Trials Network (NCTN) Program.  ECOG-ACRIN formed from the merger of the Eastern Cooperative Oncology Group (ECOG) and the American College of Radiology Imaging Network (ACRIN). 
eCRF Electronic Case Report Form
EDC Electronic Data Capture
EORTC European Organisation for Research and Treatment of Cancer conducts, develops, coordinates, and stimulates laboratory and clinical research in Europe to improve the management of cancer and related problems by increasing survival and quality of life.
EU European Union

 

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Term Definition
FACT Functional Assessment of Cancer Treatment  
FCOI Financial conflict of interest
FDA Food and Drug Administration is an agency within the U.S. Department of Health and Human Services. Consists of eight centers/offices designed to ensure the safety and effectiveness of all drugs, biological products (including blood, vaccines and tissues for transplantation), medical devices, and other services.
FDG-PET Fluorodeoxyglucose PET
FFPE  Formalin-Fixed, Paraffin-Embedded (tissue)
FWA Federalwide Assurance

 

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Term Definition
GBC Group Banking Committee
GAO U.S. Government Accountability Office
GCP Good Clinical Practice are standards that provide assurance that the data and reported results for clinical trials are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
GI Gastro-intestinal
GOG Gynecology Oncology Group, see NRG.
GU Genitourinary
GWAS Genome-wide association studies (GWAS) are used to identify common genetic factors that influence health and disease.

 

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Term Definition
HEME Alliance Hematologic Malignancy Biorepository (HEME), previously known as CALGB Leukemia Tissue Bank, is located at The Ohio State University.
HHS Department of Health and Human Services
HIPPA Health Insurance Portability and Accountability Act
HITECH Health Information Technology for Economic and Clinical Health
HMO Health Maintenance Organization: A type of managed care organization (MCO) that provides a form of health care coverage in the United States.

 

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Term Definition
IAM Identity and Access Management username and passcode issued by the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP); Alliance members must have IAM username and passcodes to access member-specific information on the Alliance website.
IB Investigator's brochure
IBCSG International Breast Cancer Surgery Group
ICC Informed Consent Content
ICD9 International Classification of Diseases; also see MedDRA
ICH International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
ID Identification
IDE Investigational Device Exemption
IND Investigational new drug; also Investigational New Drug Application.
IOM Institute of Medicine
IPEC Institutional Performance Evaluation Committee is an administrative committee under the Alliance Office of the Group Chair.
IRB Institutional Review Board
IS Information Systems
IS International System of Units; may also be referred to as SI (Systeme Internationale)
ISU Information Systems Unit
IT Information Technology

 

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Term Definition
JCAHO Joint Commission on Accreditation of Healthcare Organizations

 

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Term Definition
LAP Lead Academic Participating (LAP) sites is one of six components of the National Clinical Trials Network (NCTN) program. The Network LAP sites will provide scientific leadership in development and conduct of clinical trials in association with one or more adult Network Groups as well as substantial accrual to clinical trials conducted across the entire NCTN.
LCTB Alliance Lung Cancer Tissue Bank (LCTB) is located at Brigham and Women's Hospital.
LOA Letter of Agreement
LOI Letter of Intent
LTB CALGB Leukemia Tissue Bank, see HEME.

 

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Term Definition
MAYO Alliance Biorepository at Mayo Clinic (MAYO) is a repository for biospecimens associated with solid tumor studies, with a particular focus on neuro-oncology.
MBC Metastatic breast cancer
MDS Myelodysplastic syndrome
MedDRA Medical Dictionary for Regulatory Activities is the current standard medical terminology superseding terminology in ICD9, IMT, and others)
MRI Magnetic resonance imaging
MTD Maximum Tolerated Dose OR Maximum Tolerable Dose

 

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Term Definition
NCCCP NCI Community Cancer Centers Program, see NCORP.
NCCTG North Central Cancer Treatment Group, see Alliance.
NCDB National Cancer Data Base
NCI National Cancer Institute is a component of the National Institutes of Health (NIH) and is the federal government's principal agency for cancer research and training. the NCI provides funding and oversight for the cooperative groups.
NCIC-CTG National Cancer Institute of Canada - Clinical Trials Group: The only adult cooperative oncology group based in Canada that has a national membership and is committed to assessing all modalities of therapy across the spectrum of different types of cancer. The NCIC Clinical Trials Group is supported by a core grant received from the Canadian Cancer Society Research Institute.
NCORP NCI Community Oncology Research Program (NCORP) is a new program expanding upon the success of the Community Clinical Oncology Program (CCOP) Network (including its Minority-Based CCOPs), adding elements of the NCI Community Cancer Centers Program (NCCCP), and creating a network for cancer care delivery research. Both the CCOP Network and NCCCP are being replaced by this new program.
NCTN National Clinical Trials Network (NCTN) Program is the National Cancer Institute's consolidated and integrated transformation of the previous NCI-sponsored Clinical Trials Cooperative Group Program.  There are five U.S. network groups: Alliance, COG, ECOG-ACRIN, NRG, and SWOG.
NCVHS National Committee on Vital and Health Statistics is a statutory public advisory body to the Secretary of Health and Human Services in the area of health data and statistics.
NDA New Drug Application
NIH National Institutes of Health is the steward of medical and behavioral research for the United States. It is an agency under the U.S. Department of Health and Human Services. The NCI is an institute of the NIH.
NMDP National Marrow Donor Program is a nonprofit organization dedicated to creating an opportunity for all patients to receive the bone marrow or umbilical cord blood transplant they need, when they need it.
NRG  NRG Oncology is one of the five U.S. network groups of the NCI National Clinical Trials Network (NCTN) Program.  NRG formed from the merger of National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG)
NSABP National Surgical Adjuvant Breast and Bowel Project, see NRG

 

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Term Definition
OAOP Online Agent Order Processing is an application, deployed by CTEP Pharmaceutical Management Branch (PMB), that provides online ordering of investigational agents.
OCR Office for Civil Rights promotes and ensures that people have equal access to and opportunity to participate in and receive services in all Department of Health and Human Services (DHHS) programs without facing unlawful discrimination.
OCR Optical character recognition: The electronic identification and digital encoding of printed or handwritten characters by means of an optical scanner and specialized software; also the technology used in this process.
ODM Operational Data Modeling
OEWG Operational Efficiency Working Group was established to advise the National Cancer Institute (NCI) on strategies to "Identify the institutional barriers that prolong the time from concept approval to accrual of the first patient, and develop solutions for overcoming these barriers."
OHRP Office for Human Research Protections provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).
OMH Office of Minority Health was created by the U.S. Department of Health and Human Services. Its website contains information on a variety of subjects that affect the health of racial and ethnic populations, including cancer.
ONS Oncology Nursing Society
OPEN Oncology Patient Enrollment Network is a web-based registration system for patient enrollments onto NCI-sponsored Cooperative Group clinical trials. The system is integrated with the CTSU Enterprise System for regulatory and roster data, and with each of the Cooperative Groups' registration/randomization systems for patient registration/ randomization. OPEN provides the ability to enroll patients on a 24/7 basis.
ORI Office of Research Integrity oversees and directs Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services with the exception of the regulatory research integrity activities of the Food and Drug Administration.
OS Overall survival
OSHA Occupational Safety & Health Administration is an agency of the United States Department of Labor. Its mission is to prevent work-related injuries, illnesses, and occupational fatality by issuing and enforcing standards for workplace safety and health. It was also established to create a better workplace for all workers and to ensure the safety of everyone by making and enforcing certain standards that are needed to protect the people.
OTC Over-the-counter
OSTP Office of Science and Technology Policy
OSU Alliance Biorepository at The Ohio State University (OSU) is a repository for biospecimens associated with solid tumor studies as well as lymphoma studies.

 

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Term Definition
PATS CTEP Enterprise Protocol Authorization and Tracking System
PCO CALGB Pathology Coordinating Office, see OSU
PCPA Per-Case Payment Application is an application used by the Alliance financial department to manage institutional and financial information associated with Payment Programs.
PDF Portable Document Format
PDQ Physicians' Data Query
PDR Physicians' Desk Reference
PET Positron emission tomography
PFS Progression-free survival
PFT Pulmonary function test
PHI Protected Health Information
PI Principal investigator
PIO Protocol Information Office supports CTEP by collecting, processing, tracking and monitoring all protocol-related information between CTEP and its extramural collaborators as well as other CTEP and NCI programs. Note: Not to be confused with Alliance Central Protocol Operations Program (CPOP) Protocol Office, the Alliance unit responsible for developing and amending Alliance protocols.
PK Pharmacokinetics
PMB Pharmaceutical Management Branch provides pharmaceutical support for clinical trials sponsored by the National Cancer Institute's (NCI) Cancer Therapy Evaluation Program (CTEP).
PPI Patient Package Insert
PPP Pharmacogenomics and Population Pharmacology (PPP) Committee is part of the Alliance Translational Research Program (TRP).
PR Partial Response
PR Pulse rate
PRO Patient reported outcomes
PS Performance status
PSA prostate specific antigen
PSR Protocol Specific Requirements

 

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Term Definition
QA Quality assurance
QARC Quality Assurance Review Center
QOL Quality of Life
QTS Query Tracking System is a CALGB legacy application used by Data Coordinators (DCs) to transmit queries to CRAs regarding study and patient data. The applications tracks length of time between query transmittal and response receipt. Note: This application is used on studies that use TeleForm forms to submit data to the Statistics and Data Center. It is not used for studies the use Rave to collect, submit, and manage data.

 

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Term Definition
Rave Rave is third-party application for electronically capturing, managing and reporting clinical research data. The NCI selected this application as the standard electronic data capture system for the cooperative groups.
RCC Renal cell carcinoma
RDE Remote Data Entry
RDTS Regulatory Data Transfer System
RECIST Response Evaluation Criteria In Solid Tumors is a set of published rules that define when cancer patients improve or worsen during treatments. The first version of the criteria were published in 2000 by an international collaboration including the European Organisation for Research and Treatment of Cancer (EORTC), National Cancer Institute of the United States, and the National Cancer Institute of Canada Clinical Trials Group. In 2009, a revised set of criteria was released as RECIST v1.1. (Important Note: Refer to the protocol to ensure that you are using the correct criteria.)
RFA Radiofrequency ablation
RNA Ribonucleic acid
RRA Request for Rapid Amendment
RSS Regulatory Support System is designed to track regulatory compliance in an effort to reduce the administrative and regulatory burden on the NCTN groups. Located at the CTSU Regulatory Office, it contains regulatory documents for all adult NCI-sponsored NCTN clinical trials except prevention trials.
RT Radiologic Technology
RT Radiotherapy
RTOG Radiation Therapy Oncology Group, see NRG Oncology
RTP RSS Transaction Processor
RUMS Roster Update Management System

 

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Term Definition
SaaS Software-as-a-Service
SBRT Stereotactic body radiation therapy
SAE Serious adverse event
SAS Statistical Analysis System is a commonly used statistical analysis package.
SCT Society for Clinical Trials
SD Standard deviation
SDC Statistics and Data Management Program is one of the five Alliance programs.  SDC, also known as the Statistics and Data Center, supports the activities of the Alliance by achieving the highest standards for the conduct of clinical trials, including study design, statistical methodology, data management, protection of patients and their data, and regulatory compliance.
SEI Sensitive Electronic Information
SIG Special Interest Group
SIPs Surgery Non-Intrinsic Protocols are protocols that include surgical procedures or decision-making in the process of the clinical study but that are not the main focus of the study; these protocols may be initiated in non-surgery committees.
SMU Systems Management Unit
SNO Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education. 
SoCRA Society for Clinical Research Associates
SOP Standard operating procedure
SQA Society of Quality Assurance
SQA Surgical Quality Assurance
SQAC Surgical Quality Assurance Committee
SSO Single sign-on
STO Society for Translational Oncology
STS Specimen Tracking System, see BioMS
SPOREs Specialized Programs of Research Excellence is an NCI funding program that promotes collaborative, interdisciplinary translational cancer research.
SWOG SWOG, formerly known as the Southwest Oncology Group, is one of the five U.S. network groups of the NCI National Clinical Trials Network (NCTN) Program. 

 

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Term Definition
TBPT Tissue Banking Pathology Tools is a caBIG workspace.
TPS Tissue Procurement Service is part of the Division of Human Tissue Resource Network in the Department of Pathology at The Ohio State University. TPS serves as a resource of remnant human tissue. This service specializes in the procurement, preservation and distribution of human tissues for research of investigators at The Ohio State University and nationwide.
TRP Translational Research Program is one of the five Alliance programs. TRP focuses on molecularly driven oncology, ensuring optimal integration of translational endpoints into Alliance trials and maximizing the scientific productivity resulting from pre-existing and developing Alliance tissue resources.

 

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Term Definition
U10 Cooperative Multicenter Reproductive Medicine Network (U10) is one of the National Institutes of Health funding programs for medical research.
UAT User acceptance testing
UC Urothelial cancer

 

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Term Definition
VA Veterans Administration; U.S. Department of Veterans Affairs
VATS Video assisted thoracic surgery
VEGF Vascular endothelial growth factor
VPN Virtual Private Network

 

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Term Definition
WHO World Health Organization
WUSTL Alliance Biorepository at Washington University (WUSTL) is a repository for biospecimens associated with adjuvant and neoadjuvant trials, and the use of biospecimens for integral and integrated genomics-based biomarker studies.
W-9 Request for Taxpayer Identification Number and Certification (Form W-9)