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 […]
READ MOREP-value
The p-value is defined as the probability of obtaining a result equal to or “more extreme” than what was actually observed, when the null hypothesis (the hypothesis being tested) is […]
READ MOREPrincipal Investigator (PI)
The key individual designated to direct a research project. This person is responsible for scientific and technical direction for work performed by a party, particularly, a university.
READ MOREPrimary Purpose
The one main reason for the clinical trial. Types of primary purposes include treatment, prevention, diagnostic, supportive care, screening, health services research, and basic science. (See also Primary Purpose data […]
READ MOREPrimary Outcome Measure
The planned outcome measure in the protocol that is the most important for evaluating the effect of an intervention. Most clinical studies have one primary outcome measure, but some may […]
READ MOREPrimary Completion Date
The date that the last participant in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected. Whether the clinical study […]
READ MOREPrematurely Terminated
Study sites that are closed in which subjects have been enrolled and/or study drug dispensed, but the treatment regimen has not been completed. (Pfizer)
READ MOREPre-trial Visit
A visit that is conducted at the potential study site to assess the qualifications of the potential investigator and his/her study site team, and to determine if the site facilities […]
READ MOREPoint Estimate
The estimate of a parameter based on the study sample. (Pfizer) A single value rather than an interval or range of values, e.g., 10.3 rather than 10.0 to 10.6.
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