Page 32 - Terminology-Clinical-Research

NCI’s caBIG Clinical Research Information Exchange order to make informed decisions about health policies,
(CRIX) initiative, representing a joint NCI/FDA project programs and/or practices; 2. whose level of engagement in
to develop a physical implementation of the Janus model. the research process may vary in intensity and complexity
Note: Sometimes written as JANUS, the term is not an depending on the nature of the research and their
acronym, but harkens to the Roman god of gates and doors, information needs; 3. who can be, but is not limited to, a
beginnings and endings. practitioner, policy maker, educator, decision maker, health
care administrator, community leader, or an individual in a
health charity, patient group, private sector organization or
a media outlet.
K

L

Kaplan-Meier (KM) curve: KM curves represent the
proportion of the study population still surviving (or free
of disease or some other specified outcome or endpoint) at
successive times. Note: This is the most commonly used Label: Description of a drug product/device that includes:
method for representing overall survival or efficacy. In the the indication, who should use it, adverse events,
case of KM curves in treatment studies showing overall instructions for use, and safety information. Note: Labels
survival, the curves provide a plot for a certain time period. must be approved by regulatory authorities.
They compare patients receiving the investigative drug
to those in the control arm, showing the percentage of Labeling (content of): All text, tables, and figures in
patients who are still alive at a certain time. It calculates labeling as described in regulations for a specific product
this percentage according to how long a patient has been (e.g., 21 CFR 201.56 and 201.57 for human prescription
receiving a treatment, rather than when they entered the drugs; 201.66 for human over-the counter drugs; 21 CFR
study. The larger the separation of the curves the greater 801 for medical devices; and 21 CFR 606.122 for blood
difference between the treatment groups in the endpoint products).
being analyzed. If the treatment arms represented in the
KM curve follow a similar path, it suggests that there is Laboratory (clinical): A laboratory providing analyses of
only a small amount of difference between the arms of the samples collected in clinical care or research.
study in the endpoint being measured. If the arms were to LAR: Legally Authorized Representative.
meet, that would mean at that particular time point there
was no difference between the two arms of the study in the Last subject out/complete (LSC/LPC or LSO/LPO):
endpoint being measured. 1. The date and time when the last subject has reached a
planned or achieved milestone representing the completion
Knowledge translation: A dynamic and iterative process of the trial. 2. The last subject to complete a trial.
that includes synthesis, dissemination, exchange and
ethically sound application of knowledge to improve the Last subject/patient in: Date and time when the last
health of Canadians, provide more effective health services subject to participate in a clinical trial is enrolled.
and products and strengthen the health care system.
Last updated date: The Last Updated date is the most
Knowledge translation (end-of-grant): Covers the recent date on which changes to a study record were
diffusion, dissemination and application of knowledge that submitted to ClinicalTrials.gov. There may be a delay
researchers undertake once the findings from a project are between the Last Updated date and when the updated study
available. information is available on ClinicalTrials.gov. Also, this
date may be different from the Last Verified date.
Knowledge translation (integrated): A way of doing
research that involves decision makers/knowledge-users - Last verified date: The Last Verified date is the most
usually as members of the research team - in all stages of recent date on which all of a clinical study’s information on
the research process. ClinicalTrials.gov was confirmed as accurate and current.
This date may be different from the Last Updated date. If
Knowledge-user: An individual: 1. who is likely to be a study with a status of Recruiting; Not yet recruiting; or
able to use the knowledge generated through research in Active, not recruiting has not been confirmed within the

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