Page 17 - Terminology-Clinical-Research

Date of no objection letter: The date when Health Canada data which might aid in associating those data with an
issued a No Objection Letter to the trial sponsor, which individual. Examples include name, birth date, social
signifies that Health Canada considers the clinical trial security number, home address, telephone number, e-mail
acceptable. However, this does not indicate that the trial address, medical record numbers, health plan beneficiary
has started. It is important to note that before a clinical numbers, full-face photographic images).
trial can start, it must also be approved by a research ethics
board. Demographic data: The characteristics of participant
group or populations. This could include data on race, age,
Date of the global end of the trial: This is the date on sex and medical history, all of which can be relevant to the
which the trial is ended in all countries. clinical trial study findings.

Deadline (application): The deadline date for institutions Dependent variable: Outcomes that are measured in an
to electronically submit applications to CIHR via experiment and that are expected to change as a result of an
ResearchNet. Deadline dates are indicated in the funding experimental manipulation of the independent variable(s).
opportunity descriptions.
Deployment: Readying an electronic clinical trial system
Deadline (application/registration/letter of intent): The for field use by providing or disseminating capture devices,
latest acceptable date that an application can be courier- tokens, or passwords for users of an activated system.
stamped or submitted electronically.
Derived variable: New variable created as a function
Deadline (institution’s internal): The deadline for of existing variables and/or application of mathematical
Nominated Principal Applicants to electronically submit functions.
applications to the Institution via ResearchNet. Institutions
may define their internal deadline. This deadline may be Description of the IMP (Investigational Medicinal
earlier than the application deadline indicated in the CIHR Product): The physical description of the product (e.g.
funding opportunity. white tablet, solution).

Decision maker: An individual who makes decisions Design: 1. In the context of clinical trials, see design
about, or influences, health policies or practices. Decision configuration. 2. In the context of eClinical trials systems,
makers can be practitioners, educators, health care a design for an application to support actions on electronic
administrators, elected officials (Exception: Federal records.
elected officials), and individuals within the media, health
charities, patient user groups or the private sector. They Design configuration: Clinical trial design developed to
can work at the local community, municipal, provincial compare treatment groups in a clinical trial. Note: The
or national level. Decision makers are those individuals configuration usually requires randomization to one or
more treatment arms, each arm being allocated a different
who are likely to be able to make use of the results of the (or no) treatment. Examples include: Parallel Group
research.
Design, Crossover Design, and Factorial Designs.
Decision rule: Succinct statement of how a decision will
be reached based upon the expected foreseen clinical Development plan: An ordered program of clinical trials,
benefits in terms of outcomes of the primary endpoint. each with specific objectives.
Development process: See Drug development process.
Declaration of Helsinki: A series of guidelines adopted
by the 18th World Medical Assembly in Helsinki, Finland Developmental site agreements: Companies work with
in 1964. The Declaration addresses ethical issues for hospitals to develop instrumentation and clinical research
physicians conducting biomedical research involving applications.
humans. Recommendations include the procedures
required to ensure subject safety in clinical trials, including Device: An instrument, apparatus, implement, machine,
informed consent and Ethics Committee reviews. contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part or accessory,
Define.XML: Table used by XML review tools to that is used to diagnose, cure, treat, or prevent disease.
configure a review engine to deal with CDISC standard A device does not achieve its intended purpose through
data for a trial. chemical action or metabolism in the body.

De-identified: Removal of elements connected with

TERMINOLOGY CLINICAL RESEARCH 17