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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 ...
For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
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) and the World Health Organization (WHO), require data and safety monitoring protocols for Phase I and II clinical trials conforming to ...
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.
Clinical study report. In medicine, a clinical study report ( CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [1]
The Society for Clinical Trials ( SCT) is an American professional organization in Philadelphia, Pennsylvania dedicated to advancing the science and practice of clinical trials. Established in 1978, SCT is an international organization with a membership of hundreds of individuals from academia, industry, government, and non-profit organizations.