Organizational structure and communication strategies of the bypass angioplasty revascularization investigation: A multicenter clinical trial

Naydeck, Barbara L.; Sutton-Tyrrell, Kim; Burek, Karen; Sopko, George

doi:10.1016/0197-2456(95)00136-0

Cited by 8 publications

(6 citation statements)

References 8 publications

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“…In their study of the methodological challenges in conducting a multi-site RCT, Kutner three key qualities that characterized successful on-site study teams [4]. Naydeck et al suggested the use of operational memos, as well as regular conference calls between the coordinating center and other components of a project [3]. Specifically, they emphasized written and verbal communication between on-site study coordinators and their teams, and with their university-based research team.…”

Section: Fostering Collaborative Communication Stylesmentioning

confidence: 99%

Challenges Associated with Multi-institutional Multi-site Clinical Trial Collaborations: Lessons from a Diabetes Self-Management Interventions Study in Primary Care

Forjuoh¹,

Helduser²,

Bolin³

et al. 2015

J Clin Trials

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Researchers conducting clinical trials in multiple clinical sites with targeted populations face significant management challenges to maintain data integrity, while obtaining and retaining an adequate sample. These challenges can be further compounded when multiple institutions are involved, such as an integrated healthcare system and an academic-based partner. For example, communication among project team members can present a challenge to management of multi-site collaborations. Richards described communication as "the force that allows groups to take on their own identity" [1]. Effective communication for a research team is generally thought to be a function of pre-planning, adaption to various leadership styles, and organizational commitment [2-4]. However, a multi-site clinical trial does not necessarily fit the traditional hierarchical organizational model [3,5]. Within each clinical site, between clinical sites, and between clinical and academic collaborators, there must be common management strategies in place. Multi-site and multi-institutional studies present the added communication challenges of travel distance and time. Whether they are a clinic or academic employee, research coordinators, in particular, have significant responsibility for organizing and overseeing a site's participation in multi-site clinical trials. Few organizations have exactly the same training requirements for coordinators and, as the number of clinical trial sites increases, these variations can present challenges in trial management. Training variability has the potential to create discrepancies among study staff regarding operating procedures, data collection, and record-keeping. A high degree of control in protocol implementation, data collection, and reporting has been identified as a key component in successfully managing multi-institutional randomized controlled trials (RCTs) and can be achieved, in part, through standardized training requirements [3,6].

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Section: Fostering Collaborative Communication Stylesmentioning

confidence: 99%

Challenges Associated with Multi-institutional Multi-site Clinical Trial Collaborations: Lessons from a Diabetes Self-Management Interventions Study in Primary Care

Forjuoh¹,

Helduser²,

Bolin³

et al. 2015

J Clin Trials

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“…Virtual infrastructure may facilitate: time management [33]; systematic recruitment and allocation of participants to experimental groups [34,35]; efficient data collection and analysis [33,36]; and improved communication [37]. These factors all increase efficiency and decrease time spent on organisational aspects.…”

Section: Operation Of the Proposed Multicentre Intervention Trial Groupmentioning

confidence: 99%

Forming a national multicentre collaboration to conduct clinical trials: Increasing high‐quality research in the drug and alcohol field

Sanson‐Fisher

Brand

Shakeshaft

et al. 2010

Drug and Alcohol Review

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“…Issues might include clinical management of emergent health conditions in study subjects not covered by the protocol, or missed visit make-up specifications particularly for laboratory assays. (2) Protocol specific query. Provide a site staff member with the ability to post a query to the protocol team conceming interpretation of or appropriateness of any aspect of the protocol.…”

Section: Required Functions For a Network Query And Notification Systemmentioning

confidence: 99%

“…While there exists a literature on current webbased computer technology in such areas as data entry capabilities (e.g., remote data capture), protocol and other network document transmission, and patient randomization, publications specifically addressing the use of the internet for protocol and subject management queries, reporting adverse events, regulatory, and IRB components of clinical trials are sparse. Naydeck et al [2] outline the needs for approaches within networks that allow for the specifics of a particular clinical trial and describe a pre-web era computer system that focuses on randomization, data entry, and correspondence between the coordinating center and the clinical sites. Santoro et al [3,4] and Kiuchi [5] described systems focused on recruitment, randomization, and downloading reports of study progress.…”

Section: Introductionmentioning

confidence: 99%

A unified web-based Query and Notification System (QNS) for subject management, adverse events, regulatory, and IRB components of clinical trials

Mitchell

Shah²,

Ahmad

et al. 2005

Clinical Trials

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Even after intensive review, interpretative questions, ambiguities, contradictions, or errors, will arise once the protocol is scrutinized by site IRBs and implemented at sites. This will occur despite preparation and implementation of site protocol training, and provision of well crafted case report forms for the reporting of clinical and laboratory evaluations and adverse events. Since many staff are involved in each protocol, site investigators or study coordinators might direct protocol queries, participant management, or IRB queries to different network participants, resulting in inconsistent responses. It is important to establish a response mechanism that ensures consistent responses and their systematic documentation. For reporting of adverse events, and the submission of or documentation of completion of regulatory requirements, an easily accessible and structured communications system is also required. This paper describes the development and implementation of a user-friendly web-based query and notification system (QNS) for subject management, adverse events, regulatory, and IRB components. This system was created in the Adolescent Trials Network for HIV/AIDS Interventions (ATN), using existing web based tools with minor modifications and minimal cost. The query and notification system is interactive and allows for free flow of information among the site coordinators and both the protocol teams and the regulatory group. The process of the system is transparent to users at the sites, although its use and maintenance is controlled by Data Operations Center staff, to assure that ATN requirements for review and approval are met. This results in consistency of and timeliness of responses to queries, timeliness and accuracy of adverse event reporting and the ability for the data operations center regulatory staff to provide notification of pending or delinquent regulatory submissions.

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Organizational structure and communication strategies of the bypass angioplasty revascularization investigation: A multicenter clinical trial

Cited by 8 publications

References 8 publications

Challenges Associated with Multi-institutional Multi-site Clinical Trial Collaborations: Lessons from a Diabetes Self-Management Interventions Study in Primary Care

Challenges Associated with Multi-institutional Multi-site Clinical Trial Collaborations: Lessons from a Diabetes Self-Management Interventions Study in Primary Care

Forming a national multicentre collaboration to conduct clinical trials: Increasing high‐quality research in the drug and alcohol field

A unified web-based Query and Notification System (QNS) for subject management, adverse events, regulatory, and IRB components of clinical trials

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