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

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.

Web-based data management for a phase II clinical trial in ALS

“…Other web-based systems have been still more elaborate. Some have enhanced security through the use of real-time code generation [4]; others have more elaborate management infrastructure [12] and still others have implemented completely paper-free data collection [13]. We did not consider these more elaborate features appropriate or cost-effective for this relatively small phase II trial, but they may be highly appropriate for larger, phase III trials.…”

“…Web-based data management systems have been widely applied in clinical research in recent years [4–6]. Most of these systems have been largely devoted to electronic data capture (EDC).…”

Automated summaries of serious adverse events in the hepatitis C antiviral long-term treatment against cirrhosis trial

“…(1) One widely accepted system is based on the FDA guidelines, Good Clinical Practice: Consolidated Guideline. This guideline defines “Good Clinical Practice” (GCP) and provides a unified standard for designing, conducting, recording, and reporting of AEs in trials that involve the participation of human subjects.…”

“…Even though AE and SAE collection and official accounting are mandatory for clinical trials, there are limited detailed guidelines available that specify how to create a summary report of the event(s) in an expeditious manner to all of the different groups responsible for monitoring clinical trials. (1, 2) Prompt reporting of AEs and SAEs to the numerous interested parties, including regulatory agencies, as well as providing up to date information on each of the AEs are some of the challenges related to the maintaining of complete and accurate AE and SAE data. (3) This manuscript describes the use of a detailed SAE Summary developed for a large multi-center National Institutes of Health (NIH) – sponsored clinical trial.…”

Web-based data management for a phase II clinical trial in ALS

“…Web-based data management systems have been widely applied in clinical research in recent years [4][5][6]. Most of these systems have been largely devoted to electronic data capture (EDC).…”