Glossaries
Glossaries
| Term | Definition |
|---|---|
| protocol |
A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. [ICH E6 Glossary]
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clinical protocol; study protocol |
| protected personal data (PPD) |
Any information relating to an identified or identifiable natural person (data subject); an identifiable person is one who can be identified directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his/her physical, psychological, mental, economic, cultural or social identity. Used in Europe [EU Directive 95/46/EC]
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| prospective study |
A study with planned observations collected predominantly after the start of the study (i.e. forward-looking). Note: Examples are interventional clinical trials, including clinical trials with an adaptive trial design. [After ClinicalTrials.gov] See also retrospective study, interventional clinical trial, observational study, adaptive design, clinical study.
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| proprietary name |
A commercial name for a drug product, granted by a naming authority for use in marketing a drug/device product. [After SPL; After FDA Best Practices in Developing Proprietary Names for Human Prescription Drug Products, Guidance for Industry, December 2020] See also generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name.
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Brand Name; Trade Name |
| prophylaxis |
Practices or interventions used to help people stay healthy and avoid disease. NOTE: Involves limiting the chances of illness, injuries, or reduced health status from occurring (primary prevention) and, when diseases occur, supporting people to manage them as effectively as possible in order to prevent progression or recurrence (secondary prevention). Prevention is achieved by applying vaccines, behavioral changes, life style changes, improved nutrition, etc. [After Prevention is better than cure, UK Department of Health and Social Care, Nov 5th 2018. After Primary, secondary and tertiary prevention, Institute for Work & Health, Toronto April 2015]
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prevention |
| PROMIS |
NIH-sponsored project for the development and evaluation of PRO item banks and computer adaptive testing for pain, fatigue, physical function, social function, and emotional well-being. [NIH]
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| product dose |
The amount of a product administered in a single dose at a point in time. Usually expressed as a weight, volume, or a number of items (e.g., dosage forms) administered. The expression refers to the substance(s) contained in the Product.
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| privacy breach |
A privacy breach is the loss of, unauthorized access to, or disclosure of, personal information. [Office of the Privacy Commissioner of Canada] See also serious breach.
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| principal investigator |
An individual responsible and accountable for conducting clinical research studies in human subjects and leading a team if more than one investigator is involved with a clinical trial. NOTE: While the term is defined inconsistently within some guidance, in common usage, the term is used as defined above and the accountabilities are assigned by the sponsor. [After ICH E6 and WHO].
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| primary outcome variable |
An outcome variable specified in the protocol to be of greatest importance to the primary objective of the trial, usually the one used in the sample size calculation. NOTE: Differences between groups in the primary and secondary variable(s) are believed to be the result of the group-specific interventions. [CONSORT Statement] See also primary objective, outcome, endpoint.
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| primary objective |
The primary objective(s) is the main question to be answered and drives any statistical planning for the trial (e.g., calculation of the sample size to provide the appropriate power for statistical testing). [ICH E6 6.3] See also objective, secondary objective.
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| primary completion date |
The date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome [measure], whether the clinical trial concluded according to the pre-specified protocol or was terminated. NOTE: The primary completion date may or may not be the same as the study completion date. [ClinicalTrials.gov]
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| prevalence |
The number of the existing cases of disease or injury in a defined population at a given point in time. NOTE: The relation between incidence and prevalence varies among diseases. There may be low incidence and a high prevalence - as for diabetes - or a high incidence and a low prevalence - as for the common cold. [After Basic Epidemiology, R. Bonita and others, WHO 2006; After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Lesson 3: Measures of Risk, CDC 2012] Compare to incidence. See also morbidity rate, morbidity, mortality, incidence rate.
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| preclinical studies |
Animal studies that support Phase 1 safety and tolerance studies and must comply with good laboratory practice (GLP). NOTE: Data about a drug's activities and effects in animals help establish boundaries for safe use of the drug in subsequent human testing (clinical studies or trials).
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| preamble |
A section preceding the text of a final FDA regulation published in the Federal Register. NOTE: "The preamble is to contain a thorough and comprehensible explanation of the reasons for the Commissioner's decision on each issue" raised in comments submitted in response to the proposed regulation. [After 21CFR10.40]
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