Glossary

Division of Administrative Services (NCTR)

A collection of quality, compliance, and/or performance measurements which help management measure and control the risks associate with operating within a regulated industry.

Distinct piece of information, the plural form of datum, but often used as both the singular and plural form of the word. In software terms, data is distinct from programs that are used for manipulating data.

Sometimes used as a synonym for documentation.

Representations of facts, concepts, or instructions in a manner suitable for communication, interpretation, or processing by humans or by automated means.

(IEEE) Evaluation of the description and intended use of each data item in the software design to ensure the structure and intended use will not result in a hazard. Data structures are assessed for data dependencies that circumvent isolation, partitioning, data aliasing, and fault containment issues affecting safety, and the control or mitigation of hazards.

Evaluation of the data structure and usage in the code to ensure each is defined and used properly by the program. Usually performed in conjunction with logic analysis.

A committee of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial. DSMBs are mandatory for all NIH funded Phase III studies, and are additionally needed for the following types of studies: emergency settings, large scale randomized clinical trials, multi-center clinical trials, blinded studies, multi-center Phase I and II trials, research involving high risk interventions or vulnerable population. Phase IV trials require a DSM plan.

A DSMP is a defined plan with individuals identified for monitoring research on an individual protocol. A DSMP can establish review under: a Principal Investigator; an independent individual/safety officer; a designated medical monitor; an internal committee or board with explicit guidelines; a Data and Safety Monitoring Board; or the IRB itself. The Data and Safety Monitoring Plan details the criteria for unexpected adverse event (AE) and serious adverse event (SAE) monitoring, and data and safety reviews throughout the expected timeframe of the protocol. The Committee approves DSMPs during the original protocol submission.

(ANSI) A bus used to communicate data internally and externally to and from a processing unit or a storage device.

This function provides an interface link to obtain the inter-operational production and parametric data that populate the forms and records that were attached to the production unit. The data may be collected from the factory floor either manually or automatically from equipment in an up-to-the-minute time frame.

(ISO) A violation of data integrity. Synonym: Data Contamination.

A set of definitions of data flows, data elements, files, data bases, and processes referred to in a leveled data flow diagram set.

(IEEE) A collection of the names of all data items used in a software system, together with relevant properties of those items; e.g., length of data item, representation, etc.

A named identifier of each of the entities and their attributes that are represented in a database.

(ISO) A named unit of data that, in some contexts, is considered indivisible and in other contexts may consist of data items.

(IEEE) An exception that occurs when a program attempts to use or access data incorrectly.

(IEEE) A software V&V task to ensure that the input and output data and their formats are properly defined, and that the data flows are correct.

(IEEE) A diagram that depicts data sources, data sinks, data storage, and processes performed on data as nodes, and logical flow of data as links between the nodes. Synonyms: Data Flowchart, Data Flow Graph.

The validity of data and their relationships. For electronic records to be trustworthy and reliable, the links between raw data, metadata, and results must not be compromised or broken. Without data integrity, it is not possible to regenerate a previous result reliably.

(IEEE) The degree to which a collection of data is complete, consistent, and accurate. Synonym: Data Quality.

(ANSI) A named component of a data element. Usually the smallest component.

All the software in the technology stack between the operating system and the application software, e.g., Database Management Systems, middleware, and application enabling software.

The process of translating data from one system to another when a company replaces the current computing systems with a new one. CFR 21 Part 11 mandates that data migration implementation create accurate and complete copies of the records when they are moved to a new system.