An electronic regulatory document management system for a clinical trial network

Zhao, Wenle; Durkalski, Valerie; Pauls, Keith; Dillon, Catherine; Kim, Jaemyung; Kolk, Deneil; Silbergleit, Robert; Stevenson, Valerie; Yu, Amy Y.X.

doi:10.1016/j.cct.2009.09.005

Cited by 9 publications

(4 citation statements)

References 5 publications

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“…If we are going to continue to improve stroke care, we need to invent “teletrials.” No longer acting as passive observer and data collector, a trial coordinating center will need to have a 24/7 electronic presence in every qualified primary stroke center to screen for patients and oversee and facilitate protocol procedures. In addition, the coordinating center will also assume responsibility for preparing documents and other administrative legwork that can overwhelm ED staff that have little experience or interest in completing the extensive paperwork required at trial sites 17 . A successful coordinating center will focus on completing trials.…”

Section: Possible Solutionsmentioning

confidence: 99%

A strategic plan to accelerate development of acute stroke treatments

Marler

2012

Annals of the New York Academy of Sciences

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In order to reenergize acute stroke research and accelerate the development of new treatments, we need to transform the usual design and conduct of clinical trials to test for small but significant improvements in effectiveness, and treat patients as soon as possible after stroke onset when treatment effects are most detectable. This requires trials that include thousands of acute stroke patients. A plan to make these trials possible is proposed. There are four components: (1) free access to the electronic medical record; (2) a large stroke emergency network and clinical trial coordinating center connected in real time to hundreds of emergency departments; (3) a clinical trial technology development center; and (4) strategic leadership to raise funds, motivate clinicians to participate, and interact with politicians, insurers, legislators, and other national and international organizations working to advance the quality of stroke care.

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Section: Possible Solutionsmentioning

confidence: 99%

A strategic plan to accelerate development of acute stroke treatments

Marler

2012

Annals of the New York Academy of Sciences

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“…Typically, CCs that focus specifically on data collection and analysis are referred to as data coordinating centers (DCCs). There have been efforts to describe best practices for DCCs [11], and there are several descriptions of clinical trial management systems for specific studies [[12], [13], [14], [15]]. However, very little exists in the literature describing the creation of DCCs or the guiding principles behind their inception.…”

Section: Introductionmentioning

confidence: 99%

Creating an academic research organization to efficiently design, conduct, coordinate, and analyze clinical trials: The Center for Clinical Trials & Data Coordination

Abebe

Althouse

Comer

et al. 2019

Contemporary Clinical Trials Communications

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When properly executed, the randomized controlled trial is one of the best vehicles for assessing the effectiveness of one or more interventions. However, numerous challenges may emerge in the areas of study startup, recruitment, data quality, cost, and reporting of results. The use of well-run coordinating centers could help prevent these issues, but very little exists in the literature describing their creation or the guiding principles behind their inception.The Center for Clinical Trials & Data Coordination (CCDC) was established in 2015 through institutional funds with the intent of 1) providing relevant expertise in clinical trial design, conduct, coordination, and analysis; 2) advancing the careers of clinical investigators and CCDC-affiliated faculty; and 3) obtaining large data coordinating center (DCC) grants. We describe the organizational structure of the CCDC as well as the homegrown clinical trial management system integrating nine crucial elements: electronic data capture, eligibility and randomization, drug and external data tracking, safety reporting, outcome adjudication, data and safety monitoring, statistical analysis and reporting, data sharing, and regulatory compliance.Lastly, we share numerous lessons that can be taken from our experience. Specifically, we focus on 1) funding for DCCs, 2) the importance of DCCs to clinical researchers, 3) the expertise of DCC personnel, and 4) continually striving to improve.In conclusion, the CCDC strives to provide high-quality support for the design, conduct, coordination, and analyses of clinical trials, and we hope this paper will serve as a blueprint for future clinical trialists involved in DCCs.

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“…Motivated by the demands from trials in these networks, a comprehensive homegrown webbased clinical trial management system has been developed and has served for more than 20 multicenter clinical trials. [20][21][22] The system uses the three-tier architecture 23 with the data tier in a Microsoft Structured Query Language (SQL) Server database, the application tier developed with Microsoft Active Server Pages for data processing and user interface generation, and the presentation tier on Internet web browsers. The outcome adjudication module is one of the primary components of this homegrown clinical trial management system.…”

Section: Introductionmentioning

confidence: 99%

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system

Zhao

Pauls

2015

Clinical Trials

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Background Centralized outcome adjudication has been used widely in multi-center clinical trials in order to prevent potential biases and to reduce variations in important safety and efficacy outcome assessments. Adjudication procedures could vary significantly among different studies. In practice, the coordination of outcome adjudication procedures in many multicenter clinical trials remains as a manual process with low efficiency and high risk of delay. Motivated by the demands from two large clinical trial networks, a generic outcome adjudication module has been developed by the network’s data management center within a homegrown clinical trial management system. In this paper, the system design strategy and database structure are presented. Methods A generic database model was created to transfer different adjudication procedures into a unified set of sequential adjudication steps. Each adjudication step was defined by one activate condition, one lock condition, one to five categorical data items to capture adjudication results, and one free text field for general comments. Based on this model, a generic outcome adjudication user interface and a generic data processing program were developed within a homegrown clinical trial management system to provide automated coordination of outcome adjudication. Results By the end of 2014, this generic outcome adjudication module had been implemented in 10 multicenter trials. A total of 29 adjudication procedures were defined with the number of adjudication steps varying from 1 to 7. The implementation of a new adjudication procedure in this generic module took an experienced programmer one or two days. A total of 7,336 outcome events had been adjudicated and 16,235 adjudication step activities had been recorded. In a multicenter trial, 1144 safety outcome event submissions went through a three-step adjudication procedure and reported a median of 3.95 days from safety event case report form submission to adjudication completion. In another trial, 277 clinical outcome events were adjudicated by a six-step procedure and took a median of 23.84 days from outcome event case report form submission to adjudication procedure completion. Conclusions A generic outcome adjudication module integrated in the clinical trial management system made the automated coordination of efficacy and safety outcome adjudication a reality.

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An electronic regulatory document management system for a clinical trial network

Cited by 9 publications

References 5 publications

A strategic plan to accelerate development of acute stroke treatments

A strategic plan to accelerate development of acute stroke treatments

Creating an academic research organization to efficiently design, conduct, coordinate, and analyze clinical trials: The Center for Clinical Trials & Data Coordination

Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system

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