Tracy Ann Pasek, Natalie Napolitano, Amy Cassidy, Laura Beth Kalvas, Martha A Q Curley
{"title":"设计支持多地点国际临床试验的网站。","authors":"Tracy Ann Pasek, Natalie Napolitano, Amy Cassidy, Laura Beth Kalvas, Martha A Q Curley","doi":"10.1097/NNR.0000000000000775","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Safe and reliable implementation of complex study protocols in multisite clinical trials requires that all study personnel have 24/7 access to up-to-date study materials. Study websites can serve as an electronic manual of operations (eMOO) to support trial conduct.</p><p><strong>Objective: </strong>We describe the development, organization, and maintenance of a study website and eMOO to facilitate quick and efficient communication during conduct of a complex, multisite, international clinical trial.</p><p><strong>Methods: </strong>We worked closely with our information technology department to develop and maintain our study website, which includes a public home page, a section for parents and families, and three password-protected portals that serve as an eMOO for (a) study sites, (b) study site investigators, and (c) the operations team (e.g., clinical coordination center, data coordination center).</p><p><strong>Results: </strong>The public home page is helpful for families contemplating study participation and for nonparticipating sites considering joining our trial. The patient and family education section supports family participation in the study. The study site portal contains all information needed for local study teams to safely manage a study patient. The investigator portal provides access to research-specific materials needed to lead the study at each site. The operations team portal supports overall study management. For other scientists considering use of a study website for their multisite research, we recommend close collaboration with information technology for development and maintenance, limited and clearly defined roles for version control, and use of unmodifiable file formats to prevent unapproved alterations of study materials.</p><p><strong>Discussion: </strong>Although investment in development and maintenance has been significant, we have appreciated marked value to our operations team and study sites. Our study website development process is relevant to other scientists conducting multisite clinical research.</p>","PeriodicalId":49723,"journal":{"name":"Nursing Research","volume":" ","pages":"484-489"},"PeriodicalIF":2.2000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11518657/pdf/","citationCount":"0","resultStr":"{\"title\":\"Designing a Website to Support a Multisite, International Clinical Trial.\",\"authors\":\"Tracy Ann Pasek, Natalie Napolitano, Amy Cassidy, Laura Beth Kalvas, Martha A Q Curley\",\"doi\":\"10.1097/NNR.0000000000000775\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Safe and reliable implementation of complex study protocols in multisite clinical trials requires that all study personnel have 24/7 access to up-to-date study materials. Study websites can serve as an electronic manual of operations (eMOO) to support trial conduct.</p><p><strong>Objective: </strong>We describe the development, organization, and maintenance of a study website and eMOO to facilitate quick and efficient communication during conduct of a complex, multisite, international clinical trial.</p><p><strong>Methods: </strong>We worked closely with our information technology department to develop and maintain our study website, which includes a public home page, a section for parents and families, and three password-protected portals that serve as an eMOO for (a) study sites, (b) study site investigators, and (c) the operations team (e.g., clinical coordination center, data coordination center).</p><p><strong>Results: </strong>The public home page is helpful for families contemplating study participation and for nonparticipating sites considering joining our trial. The patient and family education section supports family participation in the study. The study site portal contains all information needed for local study teams to safely manage a study patient. The investigator portal provides access to research-specific materials needed to lead the study at each site. The operations team portal supports overall study management. For other scientists considering use of a study website for their multisite research, we recommend close collaboration with information technology for development and maintenance, limited and clearly defined roles for version control, and use of unmodifiable file formats to prevent unapproved alterations of study materials.</p><p><strong>Discussion: </strong>Although investment in development and maintenance has been significant, we have appreciated marked value to our operations team and study sites. Our study website development process is relevant to other scientists conducting multisite clinical research.</p>\",\"PeriodicalId\":49723,\"journal\":{\"name\":\"Nursing Research\",\"volume\":\" \",\"pages\":\"484-489\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11518657/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nursing Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/NNR.0000000000000775\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/9/4 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"NURSING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nursing Research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/NNR.0000000000000775","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/4 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"NURSING","Score":null,"Total":0}
Designing a Website to Support a Multisite, International Clinical Trial.
Background: Safe and reliable implementation of complex study protocols in multisite clinical trials requires that all study personnel have 24/7 access to up-to-date study materials. Study websites can serve as an electronic manual of operations (eMOO) to support trial conduct.
Objective: We describe the development, organization, and maintenance of a study website and eMOO to facilitate quick and efficient communication during conduct of a complex, multisite, international clinical trial.
Methods: We worked closely with our information technology department to develop and maintain our study website, which includes a public home page, a section for parents and families, and three password-protected portals that serve as an eMOO for (a) study sites, (b) study site investigators, and (c) the operations team (e.g., clinical coordination center, data coordination center).
Results: The public home page is helpful for families contemplating study participation and for nonparticipating sites considering joining our trial. The patient and family education section supports family participation in the study. The study site portal contains all information needed for local study teams to safely manage a study patient. The investigator portal provides access to research-specific materials needed to lead the study at each site. The operations team portal supports overall study management. For other scientists considering use of a study website for their multisite research, we recommend close collaboration with information technology for development and maintenance, limited and clearly defined roles for version control, and use of unmodifiable file formats to prevent unapproved alterations of study materials.
Discussion: Although investment in development and maintenance has been significant, we have appreciated marked value to our operations team and study sites. Our study website development process is relevant to other scientists conducting multisite clinical research.
期刊介绍：
Nursing Research is a peer-reviewed journal celebrating over 60 years as the most sought-after nursing resource; it offers more depth, more detail, and more of what today''s nurses demand. Nursing Research covers key issues, including health promotion, human responses to illness, acute care nursing research, symptom management, cost-effectiveness, vulnerable populations, health services, and community-based nursing studies. Each issue highlights the latest research techniques, quantitative and qualitative studies, and new state-of-the-art methodological strategies, including information not yet found in textbooks. Expert commentaries and briefs are also included. In addition to 6 issues per year, Nursing Research from time to time publishes supplemental content not found anywhere else.
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