Page 26 - Terminology-Clinical-Research

objective variables and the investigator’s overall impression Group sequential design: A trial design that allows a
about the state or change in state of a subject. look at the data at particular time points or after a defined
number of patients have been entered and followed up
Glossary: A collection of specialized words or terms with based on formulating a stopping rule derived from repeated
their meanings. significance tests.

GMO: A genetically modified organism (GMO) or
genetically engineered organism (GEO) is an organism
whose genetic material has been altered using genetic
engineering techniques. H

Good clinical practice (GCP): A standard for the design,
conduct, performance, monitoring, auditing, recording,
analyses, and reporting of clinical trials that provides Handwritten signature: The scripted name or legal
assurance that the data and reported results are credible and mark of an individual handwritten by that individual
accurate and that the rights, integrity, and confidentiality of and executed or adopted with the present intention to
trial subjects are protected. authenticate a writing in a permanent form. Note: The act
of signing with a writing or marking instrument such as a
Good clinical research practice (GCRP): Term pen or stylus is preserved.
sometimes used to describe GCP. See Good clinical
practice. Harmonized standard: A European Norm (EN) that has
been accepted by all Member States and has been published
Grant: Support for the direct costs of research projects in the Official Journal of the European Communities
including for the training of researchers and/or activities (OJEC).
that support the translation of research findings, conducted
by either an investigator working alone or by a group of Harms: See Severe adverse events or harms.
investigators working together.
Has data monitoring committee (DMC): Indicates
Grant (infrastructure): Funding that provides an optimum whether the clinical trial has a data monitoring committee
environment for the conduct and support of health research. (DMC) or a data safety and monitoring board (DSMB).
This includes funding for: conferences and workshops to
establish research priorities; researcher networking and Has results: Indicates that summary information about the
collaborative activities; scientific exchanges between results of a clinical study registered on ClinicalTrials.gov. is
Canadian and international researchers; programs that available in the ClinicalTrials.gov results database and can
inform researchers and other stakeholders about aspects be viewed in the study record.
of health research; and grants to selected organizations
engaged in research-related activities such as the Canadian Hazard ratio (HR): The hazard ratio is the relative risk of
Council on Animal Care and the National Council on Ethics the event (e.g. disease progression) happening in one trial
in Human Research. arm compared with the other, over the entire time period of
the trial. Note: 1. A HR of 1 means there is no difference
Grant (pending): Projects that have been approved for between the groups, a HR of 2 means that there is double
funding by CIHR however before funds can be released, the risk and a HR of 0.5 tells that there is half the risk. 2.
the Nominated Principal Applicant has to resolve issues In the example below, a HR for OS of 0.73 indicates there
with their application. Pending grants have a status of is a 27% reduction in the risk of progression or death in
“Pending” on the funding decision announcement and the the arm treated with drug A compared with drug B. It is
Notice of Decision. calculated as follows -1 – 0.73 (the HR) x 100 = 27% risk
reduction. 3. Importantly, and unlike median values, the
Grantee, grant holder: See Nominated Principal hazard ratio takes into account the difference in events over
Applicant. the entire period of the trial, not at a specific point within
it or at the end of the trial, so is a better predictor of the
Granularity: Refers to the size of an information unit treatment’s actual effect on the whole patient population.
in relation to a whole. NOTE: Structuring “privileges” This methodology has the advantage of using all available
in electronic systems is said to be highly granular when information, including patients who don’t complete the
each of many roles can differ in their capacity to act on trial for any reason. A HR is thus most useful when the risk
electronic records.

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