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The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events . The sponsor of the clinical trial develops the CRF to collect the specific data they need in ...
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 ...
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. [ 1] For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study ...
Clinical trial management system. 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 ...
Investigator's brochure. In drug development and medical device development [ 1] the Investigator's Brochure ( IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development ...
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness ( efficacy) 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 ...
A clinical research associate ( CRA ), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies.
Patient diary. A patient diary is a tool used during a clinical trial or a disease treatment to assess the patient's condition (e.g. symptom severity, quality of life) or to measure treatment compliance. An electronic patient diary registers the data in a storage device and allows for automatically monitoring the time the entry was made.