Page 39 - Terminology-Clinical-Research

and materials, and promotes innovative approaches to or involve drugs that are available for expanded access.
enhancing human subject protections. Recruitment statuses for open studies appear in green text
in ClinicalTrials.gov search results and study records.
Off-label use: A drug prescribed for conditions other than These statuses are:
those approved by the FDA.
• Recruiting
OHRP: See Office for Human Research Protections.
• Not yet recruiting
Oncolytic virus: A virus that preferentially infects and kills
cancer cells. • Available for expanded access

One-tailed test: A hypothesis test in which the values Note: For open studies, the word “Unknown,” in brown
for which we can reject the null hypothesis are located text, means that a study record with a Recruiting or Not yet
entirely in one tail of the probability distribution. Testing recruiting status has not been verified on ClinicalTrials.gov
whether one treatment is better than another (rather than within the past 2 years.
testing whether one treatment is either better or worse than
another) would be a one-tailed test. (Also called one-sided Open to enrollment: The status of a study such that a
test.) subject can be enrolled into that study. NOTE: Registry
terminology in common use is “open to recruitment”;
Ontology: An explicit formal specification of how to however, recruitment can begin upon IRB approval of
represent relationships among objects, concepts, and other the site; whereas enrollment requires availability of
entities that belong to a particular domain of experience or study supplies, subject informed consent, etc., to allow
knowledge. participation of eligible subjects.

Open access: A free availability of scientific and scholarly Open trial: See Open label.
research texts on the public internet, permitting any users
to read, download, copy, distribute, print, search, or link to Operational model: The set of CDISC data standards
the full texts of these articles, crawl them for indexing, pass (including ODM and LAB) used to capture and archive
them as data to software, or use them for any other lawful data from clinical trials.
purpose, without financial, legal, or technical barriers other
than those inseparable from gaining access to the internet Opinion (in relation to independent ethics committee):
The judgment and/or the advice provided by an
itself. The only constraint on reproduction and distribution, independent ethics committee.
and the only role for copyright in this domain, should be to
give authors control over the integrity of their work and the Oral administration: Administration by mouth.
right to be properly acknowledged and cited.
Origin: 1. Source of information collected in the course of
Open clinical trial: There are several possible meanings a clinical trial. Specifically used to differentiate between
for this term: 1. A clinical trial in which the investigator data collected at point of patient contact and data that are
and participant are aware which intervention is being used derived or calculated. 2. (SDTM) A metadata attribute
for which participant (i.e., not blinded). Random allocation defined for each dataset variable in the “Define” document
may or may not be used in such trials. Sometimes called of an SDTM submission that refers to the source of a
an “open label” design. 2. A clinical trial in which the variable (e.g., CRF, derived, sponsor defined, PRO, etc.).
investigator decides which intervention is to be used
(non-random allocation). This is sometimes called an open Original data: The first recorded study data values. Note:
label design (but some trials said to be “open label” are FDA is allowing original documents and the original data
randomized). recorded on those documents to be replaced by copies
provided that the copies have been verified as identical in
Open label: Describes a clinical trial in which masking content and meaning.
is not used. This means that all parties involved in the
trial know which participants have been assigned which Orphan drug: An orphan drug is a pharmaceutical
interventions. Opposite to blinded or double-blind study. agent that has been developed specifically to treat a rare
medical condition, the condition itself being referred to
Open studies: Clinical studies that are currently recruiting as an orphan disease. A drug for the treatment of a rare
participants, will be recruiting participants in the future, disease (affecting fewer than 200,000 people in the US or

TERMINOLOGY CLINICAL RESEARCH 39