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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.
Obtaining a certificate is voluntary in some fields, but in others, certification from a government-accredited agency may be legally required to perform certain jobs or tasks. Organizations in the United States involved in setting standards for certification include the American National Standards Institute (ANSI) and the Institute for ...
Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment.
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
Cell culture vials The University of Florida Cancer and Genetics Research Complex is an integrated medical research facility.. Medical research (or biomedical research), also known as health research, refers to the process of using scientific methods with the aim to produce knowledge about human diseases, the prevention and treatment of illness, and the promotion of health.
The patient health record is the primary legal record documenting the health care services provided to a person in any aspect of the health care system. The term includes routine clinical or office records, records of care in any health related setting, preventive care, lifestyle evaluation, research protocols and various clinical databases.
In July 2010, HHS published new rules for recognizing testing and certification bodies, scheduled to take effect when it named the new bodies. In September 2010, the Office of the National Coordinator (ONC) of HHS named CCHIT again under these new rules. CCHIT is an ONC Authorized Testing and Certification Body (ONC-ATCB).
This came after its 2001 Orlando Forum, a meeting funded by the Kellogg Foundation and the Robert Wood Johnson Foundation and called to examine management and leadership preparation practices in the U.S. healthcare industry. As a result of the meeting, a task force was appointed, with representatives of the practice and academic communities.