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A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research. The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
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HRHIS is a human resource for health information system for management of human resources for health developed by University of Dar es Salaam college of information and communication technology, Department of Computer Science and Engineering, for Ministry of Health and Social Welfare (Tanzania) and funded by the Japan International Cooperation ...
ODM is often combined with the Study Data Model standard to more fully model trial arms or trial activities. ODM is also used in sending forms data from a clinical trial system to an electronic health record (EHR) system. The ODM schema is generally divided into three categories of data: Metadata, Admin data, and Clinical data.
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices.
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) has issued guidelines on establishing an equivalence between modes of administration. [13] Their approach is hierarchical and depends on the degree of change made during the process of migration from paper to electronic format. Three levels are suggested.
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. [1] [2] These research procedures are designed for the prevention, treatment, diagnosis or understanding of disease ...
Academic clinical trials – clinical trials run at academic centers (e.g., medical schools, academic hospitals, and universities) Clinical trials unit – biomedical research units dedicated to conducting clinical trials; Epidemiology – the study of factors affecting the health and illness of populations