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Vaccine Safety Research, Data Access, and Public Trust
The results of an investigation that are deemed final given the nature and extent of the work done.
Institutional Review Board:
A committee formally established by a research institution to ensure that the rights and welfare of human subjects are protected.
A researcher who is affiliated with an institution that is the data owner or the data steward.
Investigation of a New Hypothesis:
A new study of a previously untested hypothesis.
Managed Care Organization (MCO):
(also referred to as Health Maintenance Organization (HMO)) A health care organization that, in return for prospective per capita (capitation) payments, integrates financing, care delivery, resource allocation, and quality assurance. A prepaid delivery system in which the organization (and usually its primary care physicians) assumes financial risk for the care provided to enrolled members. The organization is legally committed to provide care to its enrollees, and members must obtain care from within the system if it is to be reimbursed.
The underlying elements of information of a study or investigation which are still incomplete or subject to change.
Initial results obtained from investigations or studies often expressed in summary statements or summary-like form such as tables or graphs. These results are incomplete and subject to change prior to peer-reviewed publication.
Systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Regular, ongoing collection and analysis of data to monitor the occurrence of health problems.
The requested data are available in the database, there are enough individuals in the database with the exposures and outcomes of interest to study the proposed hypothesis, and the proposed statistical tests are possible with the available data.