Sol_Doc_75F40125R00037_Attachment 2 - Glossary.pdf

Access to Outpatient Longitudinal Data IDIQ 75F40125R00037

Attachment 2

ATTACHMENT 2. GLOSSARY

Ad-hoc services – Additional analytical and programming support, to enable FDA personnel to obtain prescriptions, patients, claims and any other utilization metrics not available through the online data tools.

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.

Characterizing duration of drug exposure – Describing the duration of patient exposure to a drug with regard to the name, strength, and dosage form of the product, length of the exposure (in days, weeks, months, etc.), other drugs used at the same time, date therapy initiated, date therapy stopped, days’ supply, quantity dispensed, prescriber specialty and demographics of the patient using the drug.

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, 2005. (Note: The FDA does not intend to use this solicitation to initiate or complete development of a resource.)

Concomitant use – One or more therapies that appear to be used in conjunction with each other at any point in time (i.e., overlapping days’ supply, same date of fill, by a specified number of days elapsed, etc.);

use of two or more drugs from the same therapeutic class or different therapeutic classes used to treat the same diagnosis.

Cross-sectional – A single observation or examination of a set of subjects at a specific point in time with respect to one or more study variables.

Currently existing – The data chosen for this award shall be a commercially available product at the time of the proposal. The FDA does not intend to use this solicitation to initiate or complete development of a resource.

Data dictionary – A document that describes the information available in the data resource. This information shall minimally include field or variable name, description, definition (including business rules for computed fields and missing data), and allowed values and percentage of discharges or patients. All fields or variables in the data resource shall be included in this document.

Dataset adjustments and corrections – Restatements of or modifications made to previously released data.

Dataset extract – A file of data consisting of individual patient level records containing the demographic and drug utilization data necessary to address a particular study question. Each dataset extract may contain multiple USC classes, markets, or years of data.

De-identified data – Data that has had key patient information removed, e.g., name, address, social security number, and date of birth, so that any user or audience shall not purposefully or inadvertently discover a patient’s identity. However, the capability of tracking a single individual (e.g., patient A) across multiple encounters over time and of differentiating that individual from another individual (e.g., patient B) shall be required.

Demographic – The age and gender of the patient shall be required. Information on race/ethnicity shall be included if available, accompanied by documentation of the origin of this data.

Desktop – Authorized FDA personnel shall be able to access the data from their own computers (i.e., no special or customized hardware shall be required for access)

Direct – Authorized FDA personnel shall be able to access raw or sample numbers from the data source from their desktop (i.e., no intervention on the contractor’s part shall be necessary. In addition, output that consists of formatted reports only shall not be acceptable).

Disclosure policy – The process of providing FDA written authorization to disclose information from this resource in public forums or sharing with third parties on collaborative projects initiated by FDA for public health safety and regulatory purposes. This process shall ensure that the information or data disclosed is accurate and does not violate any of the Offeror’s existing agreements.

Firewall-to-firewall virtual private network (VPN) – Secure TCP/IP connection between two firewalls that simulates a local area network. Encryption/decryption and authentication are mandatory for the VPN solution.

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

Immediate – Authorized FDA personnel shall be able to access the data whenever needed.

Geographic diversity – The patients whose information is represented in the data shall not be concentrated in any single geographic area, but rather shall be broadly distributed throughout the United States.

Longitudinal – The repeated observation or examination of a set of subjects followed over time with respect to one or more study variables.

Medical Claim - A medical claim is a request for payment submitted by a healthcare provider to an insurance company or other third-party payer for services rendered to a patient.

Multi-user environment – Two or more authorized FDA users shall be able to access the data at the same time from different locations.

Nationally-based, National-level, National projections, Nationwide – The ability to accurately estimate drug utilization for the entire U.S. population using the sample captured in the data.

Original prescribed product – The original prescribed product as written or indicated by the prescriber.

Outpatient – Any place where health care is received without being admitted to the hospital as an inpatient. (NB: Day surgery, ambulatory care centers, and other outpatient services provided by hospitals may be considered to be within the outpatient setting.)

Prescription claims – All dispensed prescription transactions, including prescription claims that are adjudicated to an insurance/payer, as well as prescriptions that are not adjudicated to a payer and the recipient pays the full price (sometimes referred to as “cash pay”).

Prescription drug product – Any drug approved by the FDA to be dispensed through outpatient pharmacies.

Projection or other appropriate methodologies – Projection methodology is an algorithm that can be used to reliably and accurately estimate drug utilization for the U.S. population using the sample captured in the data. Other appropriate methodologies may include, but are not limited to, gathering drug utilization data on the universe of prescriptions/patients (e.g., a “census” method), which may reduce or eliminate the need for projection. Shall a “census” method be chosen, the Contractor shall provide mutually acceptable evidence that the data are adequately representative of outpatient drug utilization in the U.S.

Raw data – Data in the form obtained from the data access tool which is not further summarized or processed.

Real-time – Real-time access refers to doing something while people are watching or waiting. FDA expects The Contractor to provide information on how readily available access to their data shall be.

Reliable – The projection method used shall yield the same or similar results in the same or similar situations (e.g., shall be reproducible and repeatable).

Robust – In cases where the assumptions underlying the projection or other appropriate methodology are not all met, the results obtained shall be the same as in similar situations where all assumptions and conditions are fully met.

Secure – At no time shall passwords, login, or data be open to inspection or intrusion by unauthorized parties.

Sub-national – U.S. geography attributes including, but not limited to data by state, Core Based Statistical Area (CBSA), Census District.

Substitution allowability – How the prescriber indicated substitution allowed or not allowed, e.g., Dispense as Written, substitution for generic allowed, etc.

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.

Valid – An assessment of how well the projected values reflect what is actually happening in the entire population of interest.