A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.
The Research Study resource describes essential information about the study, including the purpose, objective, sponsor, investigator, therapy, condition being studied, schedule of activities, and other key items.
Uses for the ResearchStudy resource include:
– Registering a clinical trial in trial registry such as clinicaltrials.gov
– Communicating study protocol information between study stakeholders
– Supporting study set up of sites, forms
– Grouping Observation resources by study
– Setting up a Schedule of Activities for the study and its subjects