Attachement_A_Glossary.pdf

ATTACHMENT A - Glossary aggregated data – any data that has been re-formatted or derived from the original data report or data set, e.g., raw data. Aggregated data are typically presented in tables, charts, and text.

commercially available – The data resource, or access to it, is available for sale or has been sold to the general public as of June 1, 2003. (Note: The FDA does not intend to use this solicitation to initiate or complete development of a resource.)

de-identified data – Data that has had key patient and hospital information removed (e.g., names, addresses, social security numbers, and dates of birth), so that any user or audience shall not purposefully or inadvertently discover either a patient’s, doctor’s, or hospital’s identity.

demographic – The age (or year of birth) and gender of the patient shall be required. Information on race/ethnicity shall be included if available, accompanied by documentation of the origin of these data.

desktop – FDA is able to access the data resource from its computers (i.e., no special or customized hardware should be required for access) direct – FDA has desktop access to raw or sample numbers from the data source (i.e., no intervention on the contractors part should be necessary.) Output that consists solely of formatted reports (i.e., no access to datasets) will not be acceptable.

full disclosure of data collection, construction, coding and configuration – detailed information on how the database sample is selected, how data are obtained and cleaned/edited for analysis, how the data resource was built, how variables are defined, and the relationship between variables within the data structure.

geographic diversity – The extent to which patients are broadly distributed throughout the database’s country of origin. (The patients whose information is in the data resource shall not be concentrated in any single geographic area).

immediate – FDA is able to access the data resource whenever needed.

indirect – FDA personnel are not able to access raw or sample numbers from the data source from their desktop.

inpatient setting – Any place where health care is received while admitted to the hospital as an inpatient (Note: Day surgery, ambulatory care centers, and other outpatient services provided by hospitals are not considered to be an inpatient setting.)

institutional review board (IRB) – A group of individuals who review study proposals and protocols to ensure that they are scientifically sound and ethically conducted.

real-time – Real-time access refers to doing something while people are watching or waiting.

FDA expects the Offeror to provide information on how readily available access to its data will be.

unlimited – Authorized FDA personnel shall have the ability to use any data element in the database in any combination or query that is necessary to address a specific issue.