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  1. Article ; Online: Development of a risk assessment and risk management tool for an academic research organization.

    VanBuren, John M / Roalstad, Shelly / Kay, Marie T / Zuspan, Sally Jo / Dean, J Michael / Brulotte, Maryse

    Contemporary clinical trials

    2022  Volume 119, Page(s) 106812

    Abstract: Background: In the past decade, regulatory agencies have released guidance around risk-based management with the goal of focusing on risks to critical aspects of a research study. Several tools have been developed aimed at implementing these guidelines. ...

    Abstract Background: In the past decade, regulatory agencies have released guidance around risk-based management with the goal of focusing on risks to critical aspects of a research study. Several tools have been developed aimed at implementing these guidelines. We designed a risk management tool to meet the demands of our academic data coordinating center.
    Methods: We developed the Risk Assessment and Risk Management (RARM) tool on three fundamental criteria of our risk/quality program: (1) Quality by Design concepts applies to all employees, regardless of the employee's role; (2) the RARM process must be economically feasible and dynamically flexible during the study startup and implementation process; and (3) responsibility of the RARM lay with the entire study team as opposed to a single quality expert.
    Results: The RARM tool has 20 elements for both risk assessment and risk management. The incorporation of both aspects of risk management allow for a seamless transition from identifying risks to actively monitoring risks throughout enrollment.
    Conclusion: The RARM tool achieves a simplified, seamless approach to risk assessment and risk management. The tool incorporates the concept of Quality by Design into daily work by having every team member contribute to the RARM tool. It also combines the risk assessment and risk management processes into a single tool which allows for a seamless transition from identifying risks to managing the risks throughout the life of the study. The instructions facilitate documentation of de-risking protocols early in development and the tool can be implemented in any platform and organization.
    MeSH term(s) Humans ; Risk Assessment ; Risk Management
    Language English
    Publishing date 2022-05-31
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2182176-8
    ISSN 1559-2030 ; 1551-7144
    ISSN (online) 1559-2030
    ISSN 1551-7144
    DOI 10.1016/j.cct.2022.106812
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

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  2. Article ; Online: Approaches for enhancing the informativeness and quality of clinical trials: Innovations and principles for implementing multicenter trials from the Trial Innovation Network.

    Lane, Karen / Palm, Marisha E / Marion, Eve / Kay, Marie T / Thompson, Dixie / Stroud, Mary / Boyle, Helen / Hillery, Shannon / Nanni, Angeline / Hildreth, Meghan / Nelson, Sarah / Burr, Jeri S / Edwards, Terri / Poole, Lori / Waddy, Salina P / Dunsmore, Sarah E / Harris, Paul / Wilkins, Consuelo / Bernard, Gordon R /
    Dean, J Michael / Dwyer, Jamie / Benjamin, Daniel K / Selker, Harry P / Hanley, Daniel F / Ford, Daniel E

    Journal of clinical and translational science

    2023  Volume 7, Issue 1, Page(s) e131

    Abstract: One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but ...

    Abstract One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.
    Language English
    Publishing date 2023-05-25
    Publishing country England
    Document type Journal Article
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2023.560
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Development, implementation, and dissemination of operational innovations across the trial innovation network.

    Palm, Marisha E / Edwards, Terri L / Wieber, Cortney / Kay, Marie T / Marion, Eve / Boone, Leslie / Nanni, Angeline / Jones, Michelle / Pham, Eilene / Hildreth, Meghan / Lane, Karen / McBee, Nichol / Benjamin, Daniel K / Bernard, Gordon R / Dean, J Michael / Dwyer, Jamie P / Ford, Daniel E / Hanley, Daniel F / Harris, Paul A /
    Wilkins, Consuelo H / Selker, Harry P

    Journal of clinical and translational science

    2023  Volume 7, Issue 1, Page(s) e251

    Abstract: Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are ... ...

    Abstract Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.
    Language English
    Publishing date 2023-10-20
    Publishing country England
    Document type Journal Article
    ISSN 2059-8661
    ISSN (online) 2059-8661
    DOI 10.1017/cts.2023.658
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: PedsQL gastrointestinal symptoms module item development: qualitative methods.

    Varni, James W / Kay, Marie T / Limbers, Christine A / Franciosi, James P / Pohl, John F

    Journal of pediatric gastroenterology and nutrition

    2012  Volume 54, Issue 5, Page(s) 664–671

    Abstract: Objectives: The objective of the present qualitative study was to develop the items and support the content validity for the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module for pediatric patients with functional ... ...

    Abstract Objectives: The objective of the present qualitative study was to develop the items and support the content validity for the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module for pediatric patients with functional gastrointestinal (GI) disorders and organic GI diseases, hereafter referred to as GI disorders.
    Methods: The iterative process included multiphase qualitative methods. A literature review of GI disorders was conducted to generate domains for the focus interviews. Six pediatric gastroenterologists with extensive clinical experience in GI disorders provided expert opinion regarding the conceptual framework. A total of 98 participants, 46 pediatric patients ages 5 to 18, and 52 parents of patients ages 2 to 18 with physician-diagnosed GI disorders (chronic constipation, functional abdominal pain, irritable bowel syndrome, inflammatory bowel disease [Crohn disease, ulcerative colitis], gastroesophageal reflux disease), participated in the focus interviews and cognitive interviewing phases, including think-aloud and cognitive debriefing protocols.
    Results: Eleven domains were derived from the qualitative methods involving patient and parent interviews and expert opinion, with content saturation achieved, resulting in 76 items. The 11 domains consisted of items measuring stomach pain, stomach upset, food and drink limits, trouble swallowing, heartburn and reflux, gas and bloating, constipation, diarrhea, worry, medicines, and communication.
    Conclusions: Qualitative methods involving pediatric patients and their parents in the item generation process support the content validity for the new PedsQL Gastrointestinal Symptoms Module. The PedsQL Gastrointestinal Symptoms Module is undergoing national multisite field testing as the next iterative phase.
    MeSH term(s) Abdominal Pain/complications ; Abdominal Pain/physiopathology ; Adolescent ; Child ; Child, Preschool ; Diarrhea/complications ; Diarrhea/physiopathology ; Female ; Focus Groups ; Gastrointestinal Diseases/complications ; Gastrointestinal Diseases/physiopathology ; Humans ; Interviews as Topic ; Male ; Parents ; Pediatrics/methods ; Qualitative Research ; Quality of Life ; Reproducibility of Results ; Sickness Impact Profile ; Surveys and Questionnaires
    Language English
    Publishing date 2012-05
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Validation Studies
    ZDB-ID 603201-1
    ISSN 1536-4801 ; 0277-2116
    ISSN (online) 1536-4801
    ISSN 0277-2116
    DOI 10.1097/MPG.0b013e31823c9b88
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1728: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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