Page 61 - Terminology-Clinical-Research

Trial statistician: A statistician who has a combination of
education/training and experience sufficient to implement
the principles in the ICH E9 guidance and who is
responsible for the statistical aspects of the trial. U

Trial status: A “PENDING” status means Health Canada
is pending the receipt of information from the sponsor
indicating that the trial started. An “ONGOING” status Unblinding: Identification of the treatment code of a
means Health Canada has received information from subject or grouped results in studies where the treatment
the sponsor indicating the proposed study start date, and assignment is unknown to the subject and investigators.
an “ENDED” status means Health Canada has received
information from the sponsor indicating that the clinical Unequal randomization: See randomization.
trial has ended.
Unexpected adverse drug reaction: An adverse
Trial subject: Subject in a clinical trial. reaction, whose nature, severity, specificity, or outcome
is not consistent with the term or description used in the
Triple-blind study: A study in which knowledge of the applicable product information.
treatment assignment(s) is concealed from the people who
organize and analyze the data of a study as well as from Unexpected serious risk: A serious adverse drug
subjects and investigators. experience that is not listed in the labeling of a drug, or that
may be symptomatically or pathophysiologically related
T-test: A statistical test used to compare the means of two to an adverse drug experience identified in the labeling,
groups of test data. but differs because of greater severity, specificity, or
prevalence.
Trustworthy (electronic records): An attribute of
records (data and documents) and signatures submitted to Uniform resource locator (URL): Address of a web page,
regulatory agencies referring to their suitability for making for example, appliedclinicaltrialsonline.com.
scientific findings of safety and efficacy that underlie
public policy decisions pertaining to market authorization. Unknown (Recruitment status): A clinical study in
Two key dimensions that determine the trustworthiness of ClinicalTrials.gov with a status of Recruiting; Not yet
eClinical trial data are data quality and data integrity. recruiting; or Active, not recruiting and whose status has
not been confirmed within the past 2 years. Studies with
Two-tailed t-test: A hypothesis test in which the values for an Unknown status are considered open studies or closed
which we can reject the null hypothesis are located entirely studies, depending on their last recorded Recruitment
in both tails of the probability distribution. Testing whether Status.
one treatment is better or worse than another (rather than
testing whether one treatment is only better than another) UP: Unanticipated Problem (involving risks to participants
would be a two-tailed test (also called two-sided test). or others).

Type 1 (or type I) error: Error made when a null US NCT number: See NCT number.
hypothesis is rejected but is actually true. Synonym: false
positive. Use case: An explicit scenario designed to help in
determining whether a system/process is capable of
Type 2 (or type II) error: Error made when an alternative performing the functions required for a particular use. A use
hypothesis is rejected when it is actually true. Synonym: case might describe, for example, how a study coordinator
false negative. would use a tablet computer to capture medical history
data.
Type 3 (or type III) error: Some statisticians use this
designation for an error made when calling the less Use of controls in a clinical trial: In controlled trials
effective treatment the more effective one. – most phase III and some phase II trials fall into this
category – the agent or regimen being investigated is
Type of comparison: How treatment arms will be compared with a control. The control may be either a
compared (e.g., Safety, Efficacy, PK/PD). May also include medically ineffectual treatment known as a placebo (if
comparison to data from other studies or sources (e.g., no effective therapies are available for the disease being
historical control).

TERMINOLOGY CLINICAL RESEARCH 61