ASCO research program quality assessment tool: Basics for a quality community-based research site.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 97-97
Author(s):  
Patricia A. Hurley ◽  
Renee Yvonne Smith ◽  
Nicholas J. Robert
Keyword(s):  
Quality Assurance ◽  
Quality Assessment ◽  
Research Program ◽  
Quality Assurance Program ◽  
Internal Quality ◽  
Community Based ◽  
Community Based Research ◽  
Minimum Standards ◽  
Research Programs ◽  
Internal Quality Assurance

97 Background: In 2008, ASCO published a statement to identify minimum standards and exemplary attributes of clinical trial sites. Recommendations were made to assist with the development and implementation of high-quality research programs. Based on feedback from an ASCO needs assessment survey, ASCO’s Community Research Forum (CRF) sought to develop a tool to help community-based research sites exceed the minimum standards of conducting clinical research, and to identify important components for an internal quality assurance program. Methods: A tool was developed to incorporate elements of ASCO publications on minimal standards and exemplary attributes of research sites. The tool was designed to assist community-based research sites with the development and implementation of an internal quality assurance program. A checklist was also developed to help sites easily conduct an assessment of their program. Community-based researchers provided feedback on the tool’s content and utilization. Feedback was incorporated and the tool was released for widespread use in March 2014. Results: The tool was very well received by reviewers. All reviewers indicated that the level of detail of the tool was sufficient; 94% indicated that it presented realistic expectations, in terms of resources required to implement; and 81% indicated that it would be valuable for conducting a quality assessment of their research program. As of July 2014, the tool was downloaded by over 150 practices from 8 different countries and early feedback continued to be favorable, particularly from small and/or new research programs. Conclusions: Many community-based research programs do not have the resources to support an effective quality assurance program and rely heavily on external audits. The ASCO Research Program Quality Assessment Tool provides self-directed continual process improvement to help community-based research sites create an internal quality assurance program and exceed minimum standards of conducting clinical research. The CRF will learn more from users of the tool about the quality of research programs and processes, and key quality metrics. The tool is available for download at www.asco.org/communityresearchforum.

Critical Aspects of a Sustainable Clinical Research Program in the Community-Based Oncology Practice

2019 ◽  
pp. 176-184 ◽  
Author(s):  
Jennifer L. Ersek ◽  
Stephanie L. Graff ◽  
Francis P. Arena ◽  
Neelima Denduluri ◽  
Edward S. Kim
Keyword(s):  
Clinical Research ◽  
Patient Care ◽  
Health Care Providers ◽  
Research Program ◽  
Improve Patient Care ◽  
Care Providers ◽  
Community Based ◽  
Technological Infrastructure ◽  
Community Based Research ◽  
Research Programs

Increasing enrollment into clinical trials is a top priority across the field of oncology. Because the vast majority of those afflicted with cancer receive their care in the community, creating strong clinical research programs in the community-based setting is important. This article comprehensively outlines the most important elements of creating and sustaining a successful community-based research program. Establishing a clear mission and defining the scope of the research program in collaboration with key physicians and administrative leadership are critical to success. Standard operating procedures should detail operational processes. Ensuring sound financial planning and protected physician time are crucial for a healthy program. Providing mentorship opportunities to investigators and other team members will provide necessary guidance for junior investigators and long-term program stability. Prioritizing provider and patient volunteer engagement through education and awareness will potentially improve enrollment and research ownership. Incorporating administrative and clinical research staff and health care providers, including physicians, advanced practice providers, and pharmacists, will result in a multidisciplinary and unified approach and may also promote research as a routine part of patient care. Regular safety and scientific meetings will reduce regulatory complications and, most importantly, improve patient care. Other keys to a successful program include establishing a diverse trial portfolio, collaboration between different institutions, and ensuring appropriate technological infrastructure. Serial programmatic review provides opportunities to refine suboptimal practices and recognize successful strategies. Community-based research programs are critical to improve access to optimal cancer care. Implementation of successful programs is possible with a collaborative and multidisciplinary approach.

scholarly journals Internal quality assurance in a clinical virology laboratory. I. Internal quality assessment.

1995 ◽  
Vol 48 (2) ◽  
pp. 168-173 ◽  
Author(s):  
J J Gray ◽  
T G Wreghitt ◽  
T A McKee ◽  
P McIntyre ◽  
C E Roth ◽  
...  
Keyword(s):  
Quality Assurance ◽  
Quality Assessment ◽  
Internal Quality ◽  
Internal Quality Assurance

Comparison of previous reports in indoor patients-a potential tool for internal quality assurance in clinical biochemistry

2012 ◽  
Vol 1 (10) ◽  
pp. 61
Author(s):  
Parveen Bansal
Keyword(s):  
Quality Assurance ◽  
Control Program ◽  
Working Hours ◽  
Quality Assurance Program ◽  
Internal Quality ◽  
Clinical Report ◽  
Quality Control Program ◽  
Internal Quality Assurance ◽  
Workflow Efficiency ◽  
Potential Tool

Laboratory testing is an important and integral part of the decision-making process and strongly influences medical diagnosis and therapies. Normally the extraneous results in a clinical report raise a doubt towards the quality assurance program of a laboratory. This communication is intended to highlight the potential use of previous reports of indoor patient in an indoor hospital laboratory as a tool for quality assurance. In this study approximately 10% of the doubtful reports were picked up randomly and the results were compared with the earlier reports of the patient retrieved from database. The study revealed that there was a significant reduction of more than 80% in the test repeats resulting in decrease in expenses on repeat tests (80%).There was a significant average reduction of time and human resource investment, decrease in the instrument working hours and increased workflow efficiency due to reduction in the test repeats. Moreover there was an increase in the confidence level of consultant towards quality control program and authenticity of the reports.

scholarly journals Assessing Clinical Trial–Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool

2016 ◽  
Vol 12 (5) ◽  
pp. e536-e547 ◽  
Author(s):  
Marjorie J. Good ◽  
Patricia Hurley ◽  
Kaitlin M. Woo ◽  
Connie Szczepanek ◽  
Teresa Stewart ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Research Program ◽  
Assessment Tool ◽  
Cancer Control ◽  
Community Based ◽  
Community Based Research ◽  
Research Programs ◽  
Number Of Patients ◽  
Clinical Trial Accrual

Purpose: Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial–associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Methods: Community-based research programs were recruited to collect and enter clinical trial–associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Results: Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. Conclusion: The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings.

scholarly journals Internal Quality Assurance for Higher Education Study Programme

2015 ◽  
Vol 1 ◽  
pp. 173
Author(s):  
Agnese Līgotne
Keyword(s):  
Higher Education ◽  
Quality Assurance ◽  
Quality Assessment ◽  
Education Quality ◽  
Internal Quality ◽  
Main Attention ◽  
Study Programme ◽  
Higher Education Quality ◽  
Internal Quality Assurance

<p>Quality assurance for study programme is necessary precondition to realize qualitative higher education. Quality assessment is important part of quality assurance cycle. There are used different methodologies, assessment criteria and indicators to assess the higher education quality. It is clear that the assessment results which study programme will be better or worse are detected by the choice of criteria. It is difficult to find objective criteria which could be used universally for all study programme types. The aim of the research is to investigate quality assurance cycle for study programme quality and pay main attention to assessment part. The aim of assessment part is to select criteria quality assessment, what characterizes main aspects for internal quality of study programme. These criteria are important preconditions for quality assurance.</p>

scholarly journals Conceptualising External and Internal Quality Assurance in Higher Education: A Pragmatist Perspective

2016 ◽  
Vol 2 ◽  
Author(s):  
Francis Ansah
Keyword(s):  
Higher Education ◽  
Quality Assurance ◽  
Current Understanding ◽  
Education Quality ◽  
Internal Quality ◽  
Practical Relevance ◽  
Higher Education Quality ◽  
Internal Quality Assurance ◽  
The Relationship ◽  
Education Quality Assurance

The traditional tension between external and internal quality assurance implementation in higher education appears to be declining, based on a rethinking of the relationship between the two concepts. Although there are quality assurance agencies that still consider external and internal quality assurance as separate entities, most quality assurance agencies now regard the two concepts as complementary. In this paper, a case is put that the present rethinking of external and internal quality assurance in most higher education settings is guided by pragmatism, but not explicitly acknowledged in the literature. For a better appreciation of pragmatists’ influence on the current understanding of the relationship between external and internal quality assurance in higher education, this paper provides a further pragmatist conceptualisation of the two concepts to enhance stakeholders’ appreciation of employing a pragmatist approach to quality assurance practices in higher education. The conceptualisation is done through a pragmatist analysis of selected international accounts on higher education quality assurance. The paper concludes that pragmatism helps to understand external and internal quality assurance as nested concepts with reciprocities of accountability and improvement roles, and influences which call for alignment of perspectives through negotiations and settlements in order to focus on their practical relevance for implementation in higher education. La tension traditionnelle entre l’implémentation de systèmes d’assurance qualité interne et externe dans l’enseignement supérieur semble s’affaiblir grâce à la reconsidération de la relation entre ces deux concepts. Bien qu’il existe des agences d’assurance qualité qui continuent à considérer les assurances qualité interne et externe comme deux entités distinctes, la plupart des agences considèrent désormais qu’elles sont complémentaires. Cet article soutient que la nouvelle manière de penser les assurances qualité interne et externe dans l’enseignement supérieur est guidée par un souci de pragmatisme mais est encore peu reconnue dans la littérature. Pour mieux apprécier l’influence des pragmatistes sur la compréhension actuelle de la relation entre les assurances qualité interne et externe, cet article offre une conceptualisation pragmatique approfondie de ces deux concepts dans le but d’augmenter l’appréciation des parties prenantes pour l’utilisation d’une telle approche. La conceptualisation proposée provient d’une analyse pragmatique d’un choix d’expériences internationales en matière d’assurance qualité pour l’enseignement supérieur. En conclusion, cet article affirme que le pragmatisme aide à comprendre les assurances qualité interne et externe comme des concepts imbriqués qui ont des rôles réciproques en ce qui concerne la responsabilisation du système et son amélioration. Ces rôles ainsi que l’influence exercée par ces deux types d’assurance qualité requièrent des négociations et accords, pour s’accorder sur les perspectives et pouvoir ensuite se concentrer pleinement sur la pertinence pratique de leur implémentation dans les systèmes d’enseignement supérieur. 

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