Page 15 - Terminology-Clinical-Research

good or bad, of components of a development (or a series Data collection: In the context of clinical research,
of developments) and other activities occurring either accessing and recording information that provides source
simultaneously, sequentially, or in an interactive manner. data for analysis and interpretation.

Current funding opportunity: A CIHR’s funding Data collection instrument: A substrate or tool (either
opportunity that is currently open for application (these electronic or paper) used to record, transcribe, or collect
opportunities are located in CIHR’s Funding Opportunities clinical data.
Database).
Data element: 1. For XML, an item of data provided in a
Current sponsor code: The current code in use by the mark-up mode to allow machine processing.
sponsor for an active substance.
2. Smallest unit of information in a transaction. 3. A
Curriculum vitae (cv): Document that outlines a person’s structured item characterized by a stem and response
educational and professional history. options together with a history of usage that can be
standardized for research purposes across studies conducted
Cytokines: Proteins that are produced by cells. Cytokines by and for NIH. Note: The mark up or tagging facilitates
interact with cells of the immune system in order to document indexing, search and retrieval, and provides
regulate the body’s response to disease and infection. standard conventions for insertion of codes.
Cytokines also mediate normal cellular processes in the
body. Data encryption standard (DES): A FIPS approved
cryptographic algorithm for encrypting (enciphering)
and decrypting (deciphering) binary coded information.
Encrypting data converts it to an unintelligible form called
D cipher. Decrypting cipher converts the data back to its
original form called plaintext. The standard specifies both
enciphering and deciphering operations, which are based
on a 64 bit binary number called a key. Unauthorized
Data: Representations of facts, concepts, or instructions recipients of the cipher who know the algorithm but do
in a manner suitable for communication, interpretation, or not have the correct key cannot derive the original data
processing by humans or by automated means. algorithmically. Note: Data that is considered sensitive
by the responsible authority or data that represents a
Data acquisition: Capture of data into a structured, high value should be cryptographically protected if it
computerized format without a human-to-computer is vulnerable to unauthorized disclosure or undetected
interface (i.e., from another measuring instrument or modification during transmission or while in storage.
computerized source). Contrast with data entry, electronic
data capture. Data entry: Human input of data into a structured,
computerized format using an interface such as a keyboard,
Data and safety monitoring board (DSMB): An pen-based tablet, or voice recognition. Note: Although data
independent advisory committee who review accumulated capture is often used synonymously, capture implies direct
safety and efficacy data in a clinical trial and advise the entry of original source data into an electronic record rather
principal investigator and/or the trial steering committee than transcription (entry) from paper source. Contrast with
on the future management of the trial. See Data monitoring data acquisition, electronic data capture; direct entry.
committee.
Data integrity: A dimension of data contributing to
Data capture: See Data entry. trustworthiness and pertaining to the systems and processes
for data capture, correction, maintenance, transmission,
Data clarification: Answer supplied by the investigator and retention. Key elements of data integrity include
in response to a query. Note: The investigator may supply security, privacy, access controls, a continuous pedigree
a new data point value to replace the initial value or a from capture to archive, stability (of values, of attribution),
confirmation of the queried data point. protection against loss or destruction, ease of review
by users responsible for data quality, proper operation
Data clarification form: A form used to query an
investigator and collect feedback to resolve questions and validation of systems, training of users. Note: In
clinical research the FDA requires that data relied on to
regarding data.

TERMINOLOGY CLINICAL RESEARCH 15