A unified web-based query and notification system (QNS) for subject management, adverse events, regulatory, and IRB components of clinical trials.

TitleA unified web-based query and notification system (QNS) for subject management, adverse events, regulatory, and IRB components of clinical trials.
Publication TypePublication
Year of Publication2005
AuthorsMitchell R, Shah M, Ahmad S, Rogers ASmith, Ellenberg JH
Corporate AuthorsAdolescent Medicine Trials Network for HIV/AIDS Interventions
JournalClin Trials
Volume2
Issue1
Pagination61-71
Date Published2005
ISSN1740-7745
KeywordsAdolescent, Clinical Protocols, Clinical Trials as Topic, Database Management Systems, Documentation, Ethics Committees, Research, HIV Infections, Humans, Information Storage and Retrieval, Interdisciplinary Communication, Internet, Research Design, Research Personnel
Abstract

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.

DOI10.1191/1740774505cn68oa
Alternate JournalClin Trials
PubMed ID16279580
Grant ListU01 HD040474 / HD / NICHD NIH HHS / United States
U01 HD040533 / HD / NICHD NIH HHS / United States
U01-HD40474 / HD / NICHD NIH HHS / United States