Appendix B
Glossary

**Please Note: The definitions used here represent their meaning for use in this report and may not have the same meaning when used in other contexts.**


Audit:

The recalculation of statistics included in a previous study report using the same final analytic dataset.


Broader Reanalysis:

The examination of variables or possibly individuals omitted from the final dataset, but would not usually involve the entire source dataset.


Confidentiality:

The prevention of the unauthorized disclosure of personal information.

Corroboration Study:

A test of the same hypothesis using a new design or study population.


Data Enclave:

A controlled, secure environment in which eligible researchers can perform analyses using data resources with restrictions on the level of identifiable entities that may be removed from the enclave.

Data Sharing Program:

A program to allow researchers access to data collected by another entity.


External Researcher:

A researcher who is not affiliated with an institution that is the data owner or the data steward.



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Vaccine Safety Research, Data Access, and Public Trust Appendix B Glossary **Please Note: The definitions used here represent their meaning for use in this report and may not have the same meaning when used in other contexts.** Audit: The recalculation of statistics included in a previous study report using the same final analytic dataset. Broader Reanalysis: The examination of variables or possibly individuals omitted from the final dataset, but would not usually involve the entire source dataset. Confidentiality: The prevention of the unauthorized disclosure of personal information. Corroboration Study: A test of the same hypothesis using a new design or study population. Data Enclave: A controlled, secure environment in which eligible researchers can perform analyses using data resources with restrictions on the level of identifiable entities that may be removed from the enclave. Data Sharing Program: A program to allow researchers access to data collected by another entity. External Researcher: A researcher who is not affiliated with an institution that is the data owner or the data steward.

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Vaccine Safety Research, Data Access, and Public Trust Findings: 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. Internal Researcher: 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. Preliminary Data: The underlying elements of information of a study or investigation which are still incomplete or subject to change. Preliminary Findings: 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. Research: Systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Surveillance: Regular, ongoing collection and analysis of data to monitor the occurrence of health problems. Technical Feasibility: 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.