Clinical Trials Simulation System Documentation
نویسندگان
چکیده
منابع مشابه
Automated real-time text messaging as a means for rapidly identifying acute stroke patients for clinical trials
BACKGROUND Recruiting stroke patients into acute treatment trials is challenging because of the urgency of clinical diagnosis, treatment, and trial inclusion. Automated alerts that identify emergency patients promptly may improve trial performance. The main purposes of this project were to develop an automated real-time text messaging system to immediately inform physicians of patients with sus...
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In radiation oncology, where treatment concepts are elaborated in interdisciplinary collaborations, handling distributed, large heterogeneous amounts of data efficiently is very important, yet challenging, for an optimal treatment of the patient as well as for research itself. This becomes a strong focus, as we step into the era of modern personalized medicine, relying on various quantitative d...
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Computer systems used for clinical trials need to have documented evidence that they are validated systems. This is a formal process that assures users (and regulatory inspectors) that the system is fit for purpose. At MRC CTU, we have successfully met this requirement for the past ten years using the traditional waterfall method of software development, which produces agreed documentation at e...
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Keywords Biological product, investigational medicinal product (IMP), clinical trial, quality Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
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Background and Objectives: Standard clinical documentation is an integral part of quality patient care. This study aimed to explore compliance of two Iranian teaching hospitals with the clinical documentation standards. Methods: A total of 400 records were surveyed. Data were collected using a checklist of standard measures. The checklist comprised 15 items selected from relevant guidelines...
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