Page 27 - Terminology-Clinical-Research

for the endpoint event being described is not constant with HRPP: Human Research Protection Program.
respect to time.
HSR: Human Subjects Research.
Health authority: A national or international health
organization that has authority over a clinical study. Note: Human pharmacology (Phase I): Human pharmacology
Used in the European Union. (Phase I) trials are the first stage of testing in human
subjects, generally comprising a small group of healthy
Health Level 7 (HL7): An ANSI-accredited Standards volunteers. This phase includes trials designed to assess the
Developing Organization (SDO) operating in the safety (pharmacovigilance), tolerability, pharmacokinetics,
healthcare arena. Note: Level 7 refers to the highest and pharmacodynamics of a drug.
level of the International Standards Organization’s (ISO)
communications model for Open Systems Interconnection Human subject: Individual who is or becomes a
(OSI), the application level. The application level addresses participant in research, either as a recipient of the test
definition of the data to be exchanged, the timing of the article or as a control. A subject may be either a healthy
interchange, and the communication of certain errors to human or a patient.
the application. Level 7 supports such functions as security
checks, participant identification, availability checks, Human subjects review board: A group of people who
review, approve, and monitor the clinical study protocol.
exchange mechanism negotiations, and, most importantly, Their role is to protect the rights and welfare of human
data exchange structuring.
research subjects participating in a study. The group
Healthcare provider: 1. One who directly or indirectly typically includes people with varying backgrounds,
administers interventions that are designed to improve including a community member, to make sure that research
the physical or emotional status of patients. 2. A person activities conducted by an organization are completely and
licensed, certified, or otherwise authorized or permitted adequately reviewed. Also known as an institutional review
by law to administer healthcare in the ordinary course of board (IRB) or ethics committee.
business or practice of a profession, including a healthcare
facility. Huriet Law: France’s regulations covering the initiation
and conduct of clinical trials.
Healthy volunteer: Subject (not a patient) in a clinical HyperText Markup Language (HTML): A specification
trial. Note: Usually healthy volunteers serve as subjects in of the W3C that provides markup of documents for display
Phase 1 trials.
in a web browser.
Herbal medicinal product: Any medicinal product
exclusively containing as active ingredients one or more Hypertext: Links in a document that permit browsers to
herbal substances or preparations. Adapted from Dir jump immediately to another document. Note: In most
browsers links are displayed as colored, underlined text.
83/2001.
Hypothesis to test: In a trial, a statement relating to the
HIPAA: The Health Insurance Portability and
Accountability Act of 1996 (HIPAA) established national possible different effect of the interventions on an outcome.
standards for electronic health care transactions and The null hypothesis of no such effect is amenable to
national identifiers for providers, health plans, and explicit statistical evaluation by a hypothesis test, which
generates a P value.
employers. It also addresses the security and privacy of
health data. All clinical trial data and activities performed Hypothesis: A theory, supposition or assumption advanced
by covered entities must comply with HIPAA regulations. as a basis for reasoning or argument, or as a guide to
experimental investigation.
Holders (award): Undergraduate and graduate students
and postdoctoral fellows supported by CIHR through
scholarships or fellowships; or researchers supported by
salary or career support grants from CIHR. I

Homeopathic medicinal product: Homeopathic medicinal
products are medicinal products based on a dilute
solution of raw material from the plant, animal or mineral
kingdoms. IDE: Investigational Device Exemption.

TERMINOLOGY CLINICAL RESEARCH 27