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Tailoring a comprehensive website to support a clinical research network



Yesko, Lauren; Blumberg, Dikla ; Vanveldhuisen, Paul; McCormack, Jennifer; Frasketi, Michael; McNeil, Jordan; Sabina, Heather

SCT Annual Meeting

Liverpool, UK


Trial Management & Research Coordination Information Systems & Technology Data Management

The Emmes Corporation, which serves as the Data and Statistics Center and the Clinical Coordinating Center for the National Institute on Drug Abuse (NIDA)-sponsored National Drug Abuse Treatment Clinical Trials Network (CTN), has recently updated its website with the goal to improve overall study conduct, accessibility to critical information, and overall network cohesiveness and efficiency within the multiple-protocol NIDA CTN environment. Each active CTN protocol has a designated dashboard which houses critical documents for study implementation and conduct, including training information, official communications, the protocol, the manual of operations, and materials for study medications and/or other interventions. Within each protocol-specific area of the website are comprehensive sets of web reports, updated nightly, that describe important study progress metrics of a protocol implementation status timeline, recruitment, retention, data quality measures, treatment exposure, availability of primary outcome, and regulatory compliance measures, presented in tabular and graphical formats. Summary reports that compare data from each protocol to the a-priori-defined expectations of the sponsor with color codes highlight study performance for the protocol investigative teams and sponsor. Similarly, regulatory reports are developed to display the status of important regulatory documents, identifying expired or soon-to-expire documents such as IRB approvals. These reports allow for continuous monitoring, prompt identification and correction of problems by investigators, site staff, the sponsor, and coordinating centers. The website also serves as a resource for network-wide activities, including a monthly Web Seminar as a forum for network members to share and exchange clinical research knowledge. This webinar is highlighted on the website and materials are stored for future reference. Committees within the network manage their own dashboard where agendas, minutes, and other communications are posted. There is also a website page known as the investigator toolbox where templates, tools, sample forms, and policies and procedures are stored and serve to guide investigators in the preparation and execution of their clinical trials. The design and implementation of this updated website for the NIDA CTN has been effective in meeting the needs of both protocol-specific as well as network-wide activities.

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