Quality Assurance Review Center
Encyclopedia
The Quality Assurance Review Center (QARC) is a research program within the University of Massachusetts Medical School
(UMMS) that provides radiotherapy (RT) quality assurance
(QA), diagnostic imaging data management
, and clinical research support. Located in Lincoln, Rhode Island
, QARC is a nationally and internationally recognized program serving the National Cancer Institute
(NCI) sponsored cooperative groups and industry partners. These cooperative groups and their industry partners conduct a wide variety of clinical trials in order to evaluate the overall effectiveness of protocol-driven cancer
treatment strategies.
was conducting RT QA reviews of leukemia
-based protocols for the CALGB, which is one of the major NCI sponsored cooperative groups. Due to the quality management
of the CALGB's trials, other cooperative groups like the Pediatric Oncology Group
(POG) and the Children's Cancer Study Group
(CCG) decided to ensure the quality of their respective trials through the auspices of QARC. It was at this time that QARC began to seek funding from the NCI in order to manage the large influx of RT data. By 1980, QARC had received its first grant monies from the NCI, as it expanded to cover a wider array of protocol-based studies. Over the course of the next fifteen years of so, QARC began to implement a series of changes to the retrospective review process, especially with regard to its Physics
/Dosimetry
division. In 1996, QARC switched its affiliation from the Brown University School of Medicine
to UMass Medical School
. By late 2003, QARC moved from its former location at the Roger Williams Medical Center
(RWMC) to offices in Providence's Federal Hill neighborhood. As of August 2010, QARC had relocated to its current site in Lincoln.
. As radiotherapy evolves in the area of image-based, target volume definitions, and as digital information continues to supplant hard-copy formats for both diagnostic imaging and RT data, QARC continually strives to support these developments. And with today's advanced technologies in the areas of motion management and other real-time delivery modifications, meeting the growing demand for quality assurance in the ever-expanding field of cancer treatment is a top priority for QARC.
, Clinical, Data Management
(DM), Information Systems
(IS), and Physics
/Dosimetry
.
, and professional development
. One previous clinical trial that was organized by the division involved French
drugmaker Sanofi-Aventis
and the experimental chemotherapeutic agent tirapazamine
. Most of the major NCI sponsored cooperative groups, which mandate that radiotherapy materials for their respective protocols be sent to QARC for review, include ACOSOG, COG
, ECOG, SWOG
, and CALGB.
who conduct both real time and retrospective reviews. In the five years since 2003, QARC has performed interventional RT reviews for over 6,000 protocol-enrolled patients.
reports. The diagnostic imaging segment of data management usually involves Computed Tomography
(CT), Positron Emission Tomography
(PET), and Magnetic Resonance Imaging
(MRI) scans. Occasionally, QARC will obtain Gallium
and Bone
scans insofar as a protocol mandates them. With the shift toward nuclear medicine
in radiology
, QARC seeks to build and maintain a vast database with its data management division.
s division maintains and upgrades QARC's digital database. As of 2008, the QARC database contained records on over 40,000 patients enrolled on more than 200 protocols. The RT information and diagnostic imaging data stored on QARC's servers
is submitted from around 1,000 hospitals in both the United States
and abroad.
calculations submitted with each patient on a protocol. In addition, the division works closely with various institutions, which include the cooperative oncology
groups and the pharmaceutical industry partners, to develop and implement new benchmarks for specific areas of radiation therapy. In keeping with its responsibility as a quality assurance agent, the division participates in initial, interventional, and final reviews so as to assure a high degree of integrity with regard to protocol guidelines.
University of Massachusetts Medical School
The University of Massachusetts Medical School is one of five campuses of the University of Massachusetts system and is home to three schools: the School of Medicine, the Graduate School of Biomedical Sciences, the Graduate School of Nursing; a biomedical research enterprise; and a range of...
(UMMS) that provides radiotherapy (RT) quality assurance
Quality Assurance
Quality assurance, or QA for short, is the systematic monitoring and evaluation of the various aspects of a project, service or facility to maximize the probability that minimum standards of quality are being attained by the production process...
(QA), diagnostic imaging data management
Data management
Data management comprises all the disciplines related to managing data as a valuable resource.- Overview :The official definition provided by DAMA International, the professional organization for those in the data management profession, is: "Data Resource Management is the development and execution...
, and clinical research support. Located in Lincoln, Rhode Island
Lincoln, Rhode Island
Lincoln is a town in Providence County, Rhode Island, United States. The population was 21,105 at the 2010 census. Lincoln is located in northeastern Rhode Island, north of Providence....
, QARC is a nationally and internationally recognized program serving the National Cancer Institute
National Cancer Institute
The National Cancer Institute is part of the National Institutes of Health , which is one of 11 agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S...
(NCI) sponsored cooperative groups and industry partners. These cooperative groups and their industry partners conduct a wide variety of clinical trials in order to evaluate the overall effectiveness of protocol-driven cancer
Cancer
Cancer , known medically as a malignant neoplasm, is a large group of different diseases, all involving unregulated cell growth. In cancer, cells divide and grow uncontrollably, forming malignant tumors, and invade nearby parts of the body. The cancer may also spread to more distant parts of the...
treatment strategies.
History
The history of QARC can be traced back to the late 1970s when Rhode Island HospitalRhode Island Hospital
Rhode Island Hospital is a private, not-for-profit hospital located in Providence, Rhode Island.-Overview:Rhode Island Hospital is the main teaching hospital of the Warren Alpert Medical School of Brown University. A major trauma center for southeastern New England, the hospital is dedicated to...
was conducting RT QA reviews of leukemia
Leukemia
Leukemia or leukaemia is a type of cancer of the blood or bone marrow characterized by an abnormal increase of immature white blood cells called "blasts". Leukemia is a broad term covering a spectrum of diseases...
-based protocols for the CALGB, which is one of the major NCI sponsored cooperative groups. Due to the quality management
Quality management
The term Quality management has a specific meaning within many business sectors. This specific definition, which does not aim to assure 'good quality' by the more general definition , can be considered to have four main components: quality planning, quality control, quality assurance and quality...
of the CALGB's trials, other cooperative groups like the Pediatric Oncology Group
Pediatric Oncology Group
The Pediatric Oncology Group was a U.S. and Canadian clinical trial cooperative group created with the mission of studying childhood cancers. It was formed by the merger of the pediatric divisions of two other cooperative groups, the Southwest Oncology Group and the CALGB...
(POG) and the Children's Cancer Study Group
Children's Cancer Study Group
The Children's Cancer Study Group was a U.S. and Canadian clinical trial cooperative group created with the mission of studying childhood cancers. The CCG was originally known as Cancer and Leukemia Group A when it was associated with CALGB. In 2000, the CCG merged with several other pediatric...
(CCG) decided to ensure the quality of their respective trials through the auspices of QARC. It was at this time that QARC began to seek funding from the NCI in order to manage the large influx of RT data. By 1980, QARC had received its first grant monies from the NCI, as it expanded to cover a wider array of protocol-based studies. Over the course of the next fifteen years of so, QARC began to implement a series of changes to the retrospective review process, especially with regard to its Physics
Physics
Physics is a natural science that involves the study of matter and its motion through spacetime, along with related concepts such as energy and force. More broadly, it is the general analysis of nature, conducted in order to understand how the universe behaves.Physics is one of the oldest academic...
/Dosimetry
Dosimetry
Radiation dosimetry is the measurement and calculation of the absorbed dose in matter and tissue resulting from the exposure to indirect and direct ionizing radiation...
division. In 1996, QARC switched its affiliation from the Brown University School of Medicine
Brown Medical School
The Warren Alpert Medical School is the medical school of Brown University, located in Providence, Rhode Island, United States. First established in 1811, the school was suspended after sixteen years of operation by university President Francis Wayland. The medical school was reinstated in 1975...
to UMass Medical School
University of Massachusetts Medical School
The University of Massachusetts Medical School is one of five campuses of the University of Massachusetts system and is home to three schools: the School of Medicine, the Graduate School of Biomedical Sciences, the Graduate School of Nursing; a biomedical research enterprise; and a range of...
. By late 2003, QARC moved from its former location at the Roger Williams Medical Center
Roger Williams Medical Center
The Roger Williams Medical Center is a teaching hospital in Providence, Rhode Island.-Overview:Founded in 1878, and located in the Smith Hill neighborhood of Providence, RWMC is community owned and governed. It is named after Roger Williams, the founder of Rhode Island. Since 1997, it has been...
(RWMC) to offices in Providence's Federal Hill neighborhood. As of August 2010, QARC had relocated to its current site in Lincoln.
Mission
The QARC mission is to improve the standard of care in the management of cancer by ensuring quality. Providing radiotherapy quality assurance is essential for ensuring the validity of data across multi-disciplinary cooperative group trials. QARC employs a methodology that is responsive and supportive of the National Cancer Clinical Trials EnterpriseNational Cancer Institute
The National Cancer Institute is part of the National Institutes of Health , which is one of 11 agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S...
. As radiotherapy evolves in the area of image-based, target volume definitions, and as digital information continues to supplant hard-copy formats for both diagnostic imaging and RT data, QARC continually strives to support these developments. And with today's advanced technologies in the areas of motion management and other real-time delivery modifications, meeting the growing demand for quality assurance in the ever-expanding field of cancer treatment is a top priority for QARC.
Organization
The QARC infrastructure is composed of five divisions. These divisions include AdministrationBusiness operations
Business operations are those ongoing recurring activities involved in the running of a business for the purpose of producing value for the stakeholders...
, Clinical, Data Management
Data management
Data management comprises all the disciplines related to managing data as a valuable resource.- Overview :The official definition provided by DAMA International, the professional organization for those in the data management profession, is: "Data Resource Management is the development and execution...
(DM), Information Systems
Information systems
Information Systems is an academic/professional discipline bridging the business field and the well-defined computer science field that is evolving toward a new scientific area of study...
(IS), and Physics
Physics
Physics is a natural science that involves the study of matter and its motion through spacetime, along with related concepts such as energy and force. More broadly, it is the general analysis of nature, conducted in order to understand how the universe behaves.Physics is one of the oldest academic...
/Dosimetry
Dosimetry
Radiation dosimetry is the measurement and calculation of the absorbed dose in matter and tissue resulting from the exposure to indirect and direct ionizing radiation...
.
Administration
The Administration division is predominantly focused on constructing and sustaining working relationships between QARC and the various NCI supported oncology groups as well as the pharmaceutical industry. It collaborates with the UMass Medical School in matters pertaining to accounting, employmentEmployment
Employment is a contract between two parties, one being the employer and the other being the employee. An employee may be defined as:- Employee :...
, and professional development
Professional development
Professional development refers to skills and knowledge attained for both personal development and career advancement. Professional development encompasses all types of facilitated learning opportunities, ranging from college degrees to formal coursework, conferences and informal learning...
. One previous clinical trial that was organized by the division involved French
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
drugmaker Sanofi-Aventis
Sanofi-Aventis
Sanofi S.A. is a multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but the...
and the experimental chemotherapeutic agent tirapazamine
Tirapazamine
Tirapazamine is an experimental anticancer drug that is activated to a toxic radical only at very low levels of oxygen . Such levels are common in human solid tumors, a phenomenon known as tumor hypoxia. Thus, tirapazamine is activated to its toxic form preferentially in the hypoxic areas of solid...
. Most of the major NCI sponsored cooperative groups, which mandate that radiotherapy materials for their respective protocols be sent to QARC for review, include ACOSOG, COG
Children's Oncology Group
The Children’s Oncology Group , a National Cancer Institute supported clinical trials group, is the world’s largest organization devoted exclusively to childhood and adolescent cancer research...
, ECOG, SWOG
SWOG
SWOG is a National Cancer Institute supported organization that conducts clinical trials in adult cancers....
, and CALGB.
Clinical
The Clinical division primarily consists of various diagnostic and therapeutic radiologistsRadiology
Radiology is a medical specialty that employs the use of imaging to both diagnose and treat disease visualized within the human body. Radiologists use an array of imaging technologies to diagnose or treat diseases...
who conduct both real time and retrospective reviews. In the five years since 2003, QARC has performed interventional RT reviews for over 6,000 protocol-enrolled patients.
Data Management
The Data Management division receives and processes all forms of data relating to a particular patient and the corresponding protocol. Typical forms of data include diagnostic imaging, physics benchmarks, and radiologyRadiology
Radiology is a medical specialty that employs the use of imaging to both diagnose and treat disease visualized within the human body. Radiologists use an array of imaging technologies to diagnose or treat diseases...
reports. The diagnostic imaging segment of data management usually involves Computed Tomography
Computed tomography
X-ray computed tomography or Computer tomography , is a medical imaging method employing tomography created by computer processing...
(CT), Positron Emission Tomography
Positron emission tomography
Positron emission tomography is nuclear medicine imaging technique that produces a three-dimensional image or picture of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide , which is introduced into the body on a...
(PET), and Magnetic Resonance Imaging
Magnetic resonance imaging
Magnetic resonance imaging , nuclear magnetic resonance imaging , or magnetic resonance tomography is a medical imaging technique used in radiology to visualize detailed internal structures...
(MRI) scans. Occasionally, QARC will obtain Gallium
Gallium scan
A gallium scan or gallium 67 scan is a type of nuclear medicine study that uses a radioactive tracer to obtain images of a specific type of tissue, or disease state of tissue. Gallium salts like gallium citrate and gallium nitrate are used. The form of salt is not important, since it is the freely...
and Bone
Bone scan
A bone scan or bone scintigraphy is a nuclear scanning test to find certain abnormalities in bone which are triggering the bone's attempts to heal. It is primarily used to help diagnose a number of conditions relating to bones, including: cancer of the bone or cancers that have spread to the bone,...
scans insofar as a protocol mandates them. With the shift toward nuclear medicine
Nuclear medicine
In nuclear medicine procedures, elemental radionuclides are combined with other elements to form chemical compounds, or else combined with existing pharmaceutical compounds, to form radiopharmaceuticals. These radiopharmaceuticals, once administered to the patient, can localize to specific organs...
in radiology
Radiology
Radiology is a medical specialty that employs the use of imaging to both diagnose and treat disease visualized within the human body. Radiologists use an array of imaging technologies to diagnose or treat diseases...
, QARC seeks to build and maintain a vast database with its data management division.
Information Systems
The Information SystemInformation system
An information system - or application landscape - is any combination of information technology and people's activities that support operations, management, and decision making. In a very broad sense, the term information system is frequently used to refer to the interaction between people,...
s division maintains and upgrades QARC's digital database. As of 2008, the QARC database contained records on over 40,000 patients enrolled on more than 200 protocols. The RT information and diagnostic imaging data stored on QARC's servers
Database server
A database server is a computer program that provides database services to other computer programs or computers, as defined by the client–server model. The term may also refer to a computer dedicated to running such a program...
is submitted from around 1,000 hospitals in both the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
and abroad.
Physics/Dosimetry
The Physics/Dosimetry division is mostly concerned with evaluating the radiation doseDose (biochemistry)
A dose is a quantity of something that may impact an organism biologically; the greater the quantity, the larger the dose. In nutrition, the term is usually applied to how much of a specific nutrient is in a person's diet or in a particular food, meal, or dietary supplement...
calculations submitted with each patient on a protocol. In addition, the division works closely with various institutions, which include the cooperative oncology
Oncology
Oncology is a branch of medicine that deals with cancer...
groups and the pharmaceutical industry partners, to develop and implement new benchmarks for specific areas of radiation therapy. In keeping with its responsibility as a quality assurance agent, the division participates in initial, interventional, and final reviews so as to assure a high degree of integrity with regard to protocol guidelines.
Services
- Protocol Development
- Site Credentialing
- Data Acquisition
- Case Management & Archiving
- RadiologyRadiologyRadiology is a medical specialty that employs the use of imaging to both diagnose and treat disease visualized within the human body. Radiologists use an array of imaging technologies to diagnose or treat diseases...
& Radiation TherapyRadiation therapyRadiation therapy , radiation oncology, or radiotherapy , sometimes abbreviated to XRT or DXT, is the medical use of ionizing radiation, generally as part of cancer treatment to control malignant cells.Radiation therapy is commonly applied to the cancerous tumor because of its ability to control...
Case Review - Institutional Performance Evaluation & Reporting
- Research & Publications