Page 46 - Terminology-Clinical-Research

size calculation. Note: Differences between groups in the role of program leader who is active in the Canadian
the primary and secondary variable(s) are believed to be academic or research environment and whose role includes
the result of the group-specific interventions. Synonyms: an expectation to engage in research must also: 1. be
primary endpoint, outcome. autonomous regarding their research activities; and 2. have
an academic or research appointment at a CIHR eligible
Principal exclusion criteria: Reasons for exclusion of institution which: a. allows the individual to pursue the
subjects from the clinical trial from among the exclusion proposed research program, to engage in independent
criteria described in the protocol. research activities for the entire duration of the funding, to
act as the primary supervisor of trainees, and to publish the
Principal inclusion criteria: Reasons for the inclusion of research results; and b. obliges the individual to conform to
subjects in the clinical trial.
institutional regulations concerning the conduct of research,
Principal investigator (PI): The person who is responsible the supervision of trainees, and the employment conditions
for the scientific and technical direction of the entire of staff paid with CIHR funding. Individuals who are
clinical study (for example, for all sites of a multisite not located within the Canadian academic or research
study). environment at a CIHR eligible institution, as defined
above (e.g., knowledge-users, researchers who are not
rocedure: In health care, this can be a test (such as taking located in Canada), may apply as a program leader. These
blood to measure cholesterol) or a treatment (like surgery individuals are not required to meet the expectations noted
or an injection of a drug). In research, a trial’s protocol above; however, they must apply jointly with a program
describes the procedures (tests and/or treatments) carried leader who does meet the above expectations.
out on or by the participants and/or investigators.
Program leader - administrative coordinator: The
Product code: This is a code designated by the sponsor individual who assumes the role of administrative
who represents the name routinely used by the sponsor to coordinator for the grant must also be in a role of program
identify the product in the clinical trial documentation. leader. The administrative coordinator assumes all
responsibility for administrative matters related to the grant
Product name: In the absence of trade name this is the including but not limited to submitting the application
name routinely used by a sponsor to identify the IMP in the and coordinating any required reporting. In cases when
Clinical Trial Documentation. there are multiple program leaders, the administrative
coordinator must be from a Canadian academic or research
Product: 1. Drug product: A finished dosage form that environment at a CIHR eligible institution. Note: CIHR
contains a drug substance. 2. A physical entity that is requires all program leaders to be fully accountable
intended to diagnose, treat, or prevent a disease or other for setting and overseeing the intellectual and strategic
abnormal condition and subject to regulatory authority.
direction of the CIHR-funded program of research. The
Professor (adjunct): An individual who has: 1. a primary dual role as administrative coordinator does not imply
position at an institution other than the academic institution a superior contribution to the leadership of the research
providing adjunct professor status; and 2. an academic program.
appointment (at an institution other than their primary Progressive free survival (PFS): The proportion of
position) as an independent researcher.
patients who continue to live with a disease that is not
Program expert: A program expert is an individual who getting worse (i.e. not progressive disease [PD]). For
participates in or contributes to the program of research but example, PFS-6 is the rate, or proportion of patients given
does not direct the program. The participation of a program a treatment that survive without their disease worsening
expert may span the full duration of the grant or may only at six months after treatment began. Note: Disease
be required for a portion of the funding period. Program progression is often symptomatic and uncomfortable,
experts may be named on a grant application depending so delaying disease progression is very meaningful for
on their level of involvement and at the discretion of the patients and is an important goal for physicians and nurses
program leader(s). If a medication becomes ineffective, a patient can switch to
another therapy (crossover) or take additional treatments.
Program leader: A program leader is defined as an Unlike some other endpoints (e.g. OS), PFS is not affected
individual who will be responsible for setting and by this crossover or subsequent lines of therapy (a later and
overseeing the intellectual and strategic direction of the usually different treatment to the previous one), as it is only
CIHR-funded program of research. Any individual in applicable until disease worsens.

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