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Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. [1]
Clinical data standards are used to store and communicate information related to healthcare so that its meaning is unambiguous. They are used in clinical practice, in activity analysis and finding, and in research and development. There are many existing and proposed standards and many bodies working in this field.
Computer-based test interpretation (CBTI) programs are technological tools that have been commonly used to interpret data in psychological assessments since the 1960s. CBTI programs are used for a myriad of psychological tests, like clinical interviews or problem rating, but are most frequently exercised in psychological and neuropsychological ...
Accurate computer models of a treatment and its deployment, as well as patient characteristics, are necessary precursors for the development of in silico clinical trials. [5] [6] [8] [9] In such a scenario, ‘virtual’ patients would be given a ‘virtual’ treatment, enabling observation through a computer simulation of how the candidate biomedical product performs and whether it produces ...
Field experiments allow researchers to collect diverse amounts and types of data. For example, a researcher could design an experiment that uses pre- and post-trial information in an appropriate statistical inference method to see if an intervention has an effect on subject-level changes in outcomes.
Some of the problems tackled by CRI are: creation of data warehouses of health care data that can be used for research, support of data collection in clinical trials by the use of electronic data capture systems, streamlining ethical approvals and renewals (in US the responsible entity is the local institutional review board), maintenance of ...
A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable ...
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.