Page 42 - Terminology-Clinical-Research

and overarching support of health research flows both transcribing the views expressed by the patient, but the
ways: CIHR values the input and support of its Partners, term does not apply to outcomes recorded by observers
but is also available to share expertise and lessons learned. who rely on their own judgment. A PRO is usually a
Congruent partners can become competition partners if a subjective assessment of feeling or function distinguished
funding opportunity is developed. from a self-reported objective measurement such as body
weight.
Partnership: A formalized working relationship between
two or more organizations with separate identities and PAVIR: Palo Alto Veterans Institute for Research.
independent accountabilities and is based on mutual
benefit and a clear understanding or agreement that sets PD/PI: Protocol Director.
out the shared goal and objectives and the terms of the Pediatric Investigation Plan (PIP): Document upon
arrangement.
which the development and authorisation of medicinal
Password aging: A practice applying to multi-user products for the paediatric population is based. It is
computer systems where the validity of a password presented by an applicant early during the development of a
expires after a certain pre-set period. Note: FDA requires product to the EMA Paediatric Committee in order to agree
that passwords that are part of electronic signatures be a paediatric development plan.
“periodically checked, recalled or revised,” but does not Pediatric population: Population that may include pre-
mandate password aging.
term newborns, newborns, children or adolescents.
Pathologic complete response (pCR): The absence of any
residual invasive cancer after treatment. Peer review: Review of a clinical trial by independent
experts. These experts review the trials for scientific merit,
Patient: Person under a physician’s care for a particular validity, participant safety, and ethical considerations.
disease or condition. Note: A subject in a clinical trial is Performance status (PS): Measure of how well a patient
not necessarily a patient, but a patient in a clinical trial is a
subject. with a cancer diagnosis can perform ordinary tasks in daily
life before, during or after treatment. Specific numeric
Patient file: One that contains demographic, medical, and PS scales indicate levels of disability due to disease, and/
treatment information about a patient or subject. It may be or severity of symptoms. Two main scales are: 1. The
paper- or computer-based or a mixture of computer and Eastern Cooperative Oncology Group (ECOG): Rates a
paper records. patient’s performance status from zero to five, where zero
is fully active and five is dead. A person is a three if they
Patient population: Patients must meet specific criteria are capable of only limited self-care, or confined to bed or
if they are to be included in a trial. Common entry criteria chair for more than 50% of waking hours. 2. Karnofsky
include: having a certain type of cancer, having a particular status: Rates the severity of cancer related symptoms and
treatment history, and being in a certain age group. Entry degree of disability on a scale from 100% (no symptoms)
criteria help ensure that the people in the trial are as similar to 0% (dead). A 50% rating indicates that a patient
as possible to each other (in terms of basic profile, type requires considerable assistance and frequent medical care.
and stage of disease), so that the results of any treatment Treatments for cancer might be expected to impact on PS
effect can be associated as much as possible with the drug scores – both positively if disease burden is reduced or
treatment being studied and not other factors. negatively if treatments have side effects that affect the
patient’s ability to perform ordinary tasks.
Patient volunteer: A patient volunteer has a known health
problem and participates in research to better understand, Performed activity: Clinical trial events as they actually
diagnose, treat, or cure that disease or condition. occurred (as compared with events planned in the protocol).
Patient-reported outcome (PRO): Information coming Period effect: An effect occurring during a period of a
directly from patients or subjects through interviews trial in which subjects are observed and no treatment is
or self-completed questionnaires or other data capture administered.
tools such as diaries about their life, health condition(s),
and treatment. Note: PROs are used to assess outcomes Permissible values: Limited universe of options for data
involving the patients’/ subjects’ perceptions, symptoms, items. (e.g., dropdown menus, code lists, pick lists).
satisfaction with treatment, adherence to prescribed Per-protocol analysis set: The set of data generated by
regimens. PROs include outcomes recorded by interviewers

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