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Article
Open AccessAccess to routinely collected health data for clinical trials – review of successful data requests to UK registries
Clinical trials generally each collect their own data despite routinely collected health data (RCHD) increasing in quality and breadth. Our aim is to quantify UK-based randomised controlled trials (RCTs) acces...
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Article
Open AccessChanging platforms without stop** the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons
There is limited research and literature on the data management challenges encountered in multi-arm, multi-stage platform and umbrella protocols. These trial designs allow both (1) seamless addition of new res...
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Article
Open AccessEarly warnings and repayment plans: novel trial management methods for monitoring and managing data return rates in a multi-centre phase III randomised controlled trial with paper Case Report Forms
Monitoring and managing data returns in multi-centre randomised controlled trials is an important aspect of trial management. Maintaining consistently high data return rates has various benefits for trials, in...
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Article
Open AccessImplementing monitoring triggers and matching of triggered and control sites in the TEMPER study: a description and evaluation of a triggered monitoring management system
Triggered monitoring in clinical trials is a risk-based monitoring approach where triggers (centrally monitored, predefined key risk and performance indicators) drive the extent, timing, and frequency of monit...
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Article
Open AccessUpdate on the temper study: targeted monitoring, prospective evaluation and refinement
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Article
Open AccessComparing the use of traditional and agile development methodologies in a clinical trials environment
