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The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
In 2019, the book Operations research in South Africa: The first 50 years, [9] was published by the Society, with editors Prof JH Van Vuuren and Prof HA Kruger. Both Van Vuuren and Kruger are Fellows of ORSSA, an award given to members of ORSSA who served the Society or the science and profession in an exemplary manner over a considerable ...
The Principal Investigators and host institutions for the African sites are: Dr. Jimmy Volmink who is the Dean of the Faculty of Health Sciences at Stellenbosch University in South Africa; Dr. Clement Adebamowo at the Institute of Human Virology in Nigeria; Dr. David Guwattude at Makerere University in Kampala and Dr. Francis Bajunirwe at Mbarara University in Mbarara, Uganda; and Dr. Marina ...
The Consortium for Advanced Research Training in Africa abbreviated as CARTA is a partnership involving eight academic and four research institutions from Sub-Saharan Africa to strengthen research infrastructure and the management capacity of African universities.
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...
The Clinical Trials Facilitation Group (CTFG) of the Heads of Medicines Agency issued a Q&A document in 2017 addressing Good Laboratory Practice (GLP) requirements within the context of clinical trials for human medicines. This document aims to provide clarification and guidance on GLP principles applicable to non-clinical safety studies ...
A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. [1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations .
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