Page 47 - Terminology-Clinical-Research

PROMIS: NIH-sponsored project for the development Approval by the sponsor usually initiates secondary
and evaluation of PRO item banks and computer adaptive approvals by IRBs, regulatory authorities, and sites.
testing for pain, fatigue, physical function, social function, Protocol amendments usually also require a cycle of
and emotional well-being. approval by sponsor and study staff prior to taking effect.

Prophylaxis: Medical or public health measure taken Protocol deviation: A variation from processes or
whose purpose is to prevent, rather than treat or cure a procedures defined in a protocol. Deviations usually do not
disease. Primary prophylaxis is generally intended to preclude the overall evaluability of subject data for either
prevent the development of a disease, while secondary efficacy or safety, and are often acknowledged and accepted
prophylaxis is intended to prevent the disease, once in advance by the sponsor. Note: Good clinical practice
contracted by a patient, from worsening. recommends that deviations be summarized by site and by
category as part of the report of study results so that the
Proposal component: Specific methodology or activity. possible importance of the deviations to the findings of the
study can be assessed.
Proposed date of start of recruitment: The anticipated
start date for the recruitment of subjects (patients) for a Protocol Identifying Number: Any of one or more unique
clinical trial. codes that refers to a specific clinical trial protocol. Note:
There may be multiple numbers (National number, co-op
Proprietary name: A commercial name granted by a group number).
naming authority for use in marketing a drug/device
product. Synonyms: trade name, brand name. Protocol number: A variable length, alpha-numeric
sequence used by Sponsors to assign a reference number to
Prospective study: A prospective study identifies subjects, their protocol.
applies a treatment and follows them over time to measure
their progress/outcomes relative to a predetermined set Protocol referenced documents: Protocol referenced
of criteria or endpoints. Note: Randomized controlled documents that optionally supplement the ICH GCP
trials are always prospective studies. Cohort studies recommended sections of a protocol giving background
are commonly either prospective or retrospective, information and rationale for the trial.
whereas case-control studies are usually retrospective. In
Epidemiology, “prospective study” is sometimes misused Protocol title: Three categories of protocol title have
as a synonym for cohort study. evolved to address distinct standardized use cases. 1)
Scientific Title: A comprehensive summary of study design
Protected health information (PHI): Any information and objectives, aimed at scientific audience. 2) Public Title:
about a participant’s health history or status. By law, this is A brief description intended for the lay public in easily
required to be kept confidential. understood language. 3) Trial Acronym: Brief popular
identifier. Note: The scientific title should include the trial
Protocol: A document that describes the objective(s), acronym, if applicable. Scientific title may also be referred
design, methodology, statistical considerations, and to as “official title.” Public title may also be referred to as
organization of a trial. The protocol usually also gives “brief title.”
the background and rationale for the trial, but these could
be provided in other protocol referenced documents. Protocol violation: A significant departure from processes
Throughout the ICH GCP Guideline the term protocol or procedures that were required by the protocol. Violations
refers to protocol and protocol amendments. Note: Present often result in data that are not deemed evaluable for a per-
usage can refer to any of three distinct entities: 1) the plan protocol analysis, and may require that the subject(s) who
(i.e., content) of a protocol, 2) the protocol document, and violate the protocol be discontinued from the study.
3) a series of tests or treatments (as in oncology).
Proxy (as an origin of outcome measures): A proposed
Protocol amendment(s): A written description of a standardized qualifier variable to describe the origin of
change(s) to or formal clarification of a protocol. observations of the Findings class resulting from outcomes
measures. Proxy describes outcome data furnished by
Protocol approval (Sponsor): Sponsor action at the someone other than the patient and distinguishes the origin
completion of protocol development that is marked when of the outcome from a self-report (PRO) directly from
the signature of the last reviewer on the protocol approval
form has been obtained, signifying that all reviewer the patient. Note: The term proxy helps qualify outcomes
measures that record feelings and symptoms reported by
changes to the protocol have been incorporated. Note:

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