Glossary

A collection of related records. Synonym: File.

(IEEE) The equipment which accepts data signals after transmission.

Regrouping of data so that important trends and deviations can be more easily seen and understood.

(IEEE) A physical or logical relationship among data elements, designed to support specific data manipulation functions.

A structured software design technique wherein the architecture of a system is derived from analysis of the structure of the data sets with which the system must deal.

(IEEE) A diagram that depicts a set of data elements, their attributes, and the logical relationships among them.

A satisfactory assurance between the covered entity and a researcher using a limited data set that the data will only be used for specific uses and disclosures. The data use agreement is required to include the following information: to establish that the data will be used for research, public health or health care operations (further uses or disclosure are not permitted); to establish who is permitted to use or receive the limited data set; and to provide that the limited data set recipient will:(1)Not use or further disclose the information other than as permitted by the data use agreement or as required by law(2)Use appropriate safeguards to prevent use or disclosure of the information other than as provided in the agreement(3)Report to the covered entity any identified use or disclosure not provided for in the agreement(4)Ensure that any agents, including a subcontractor, to whom the limited data sets are provided agree to the same restrictions and conditions that apply to the recipient(5)Not identify the information or contact the individuals.

The checking of data for correctness or compliance with applicable standards, rules, and conventions.

(ISO) A process used to determine if data are inaccurate, incomplete, or unreasonable. The process may include format checks, completeness checks, check key tests, reasonableness checks and limit checks.

(ANSI) A collection of interrelated data, often with controlled redundancy, organized according to a schema to serve one or more applications. The data are stored so that they can be used by different programs without concern for the data structure or organization. A common approach is used to add new data and to modify and retrieve existing data.

(IEEE) Software V&V task to ensure that the database structure and access methods are compatible with the logical design.

The degree to which a database is protected from exposure to accidental or malicious alteration or destruction.

Document Accountability and Tracking System (CBER)

Division of Anti-viral Products (CDER)

Drug Abuse Warning Network

Double-Blind

Database

Division of Biostatistics (CBER)

Division of Biometrics (CDER)

Division of Blood Applications (CBER)

Division of Bioanalytical Chemistry (CFSAN)

Division of Blood Collection and Processing (CBER)

Division of Bioequivalence (CDER)

Division of Budget Execution and Control (OC)

Division of Blood Establishment and Product Applications