Page 56 - Terminology-Clinical-Research

particular interest included in clinical trials to ensure that the variance.
their specific characteristics are considered in interpretation
of data (e.g., geriatric). Standard error: The standard deviation of the sampling
distribution of a statistic. Measurements taken from a
Specific paediatric formulation: Formulation specifically sample of the population will vary from sample to sample.
developed for paediatric use. The standard error is a measure of the variation in the
sample statistic over all possible samples of the same size.
Specific vulnerable populations: Clinical trial includes The standard error decreases as the sample size increases.
subjects (healthy volunteers or patients), who are
considered to be part of a population at risk. Standard operating procedures (SOP): Detailed, written
instructions to achieve uniformity of the performance of a
Sponsor: 1. An individual, company, institution, or specific function.
organization that takes responsibility for the initiation and
management of a clinical trial, although may or may not be Standard treatment: A treatment currently in wide use
the main funding organization. If there is also a secondary and approved by the FDA, considered to be effective in the
sponsor, this entity would be considered the primary treatment of a specific disease or condition.
sponsor. 2. A corporation or agency whose employees
conduct the investigation is considered a sponsor and the Standard: Criterion or specification established by
employees are considered investigators. authority or consensus for 1. Measuring performance or
quality; 2. Specifying conventions that support interchange
Sponsor (lead): The Sponsor is the organization or person of common materials and information. Note: CDISC
who oversees the clinical study and is responsible for standards exist to support the exchange of clinical data, for
analyzing the study data. example, at both the syntactic and semantic levels.

Sponsor Country: Country name of the organisation or Start Date: The date upon which the clinical trial
individual who is providing the finance or resources for the commenced.
clinical trial.
Statistical analysis plan: A document that contains a more
Sponsor-investigator: An individual who both initiates technical and detailed elaboration of the principal features
and conducts, alone or with others, a clinical trial and under of the analysis described in the protocol, and includes
whose immediate direction the investigational product detailed procedures for executing the statistical analysis of
is administered to, dispensed to, or used by a subject. the primary and secondary variables and other data.
Note: The term does not include any person other than
an individual (i.e., it does not include a corporation or an Statistical method: The particular mathematical tests and
agency). The obligations of a sponsor-investigator include techniques that are to be used to evaluate the clinical data
both those of a sponsor and those of an investigator. in a trial.

Sponsor’s protocol code number: Unique Identifier Statistical significance: State that applies when a
number for the Protocol e.g. Trial acronym and Year (MAG hypothesis is rejected. Whether or not a given result is
98). significant depends on the significance level adopted. For
example, one may say “significant at the 5% level.” This
Sponsor-investigator: The person who both initiates and implies that when the null hypothesis is true there is only a
conducts the clinical study. 1 in 20 chance of rejecting it.

Stakeholder (environmental assessment): A person Statistician: One versed in or engaged in compiling
who: 1. has a shared interest in the project, through their statistics.
involvement in the project; or 2. may be in the geographic
locality where the proposal takes place; or 3. may be Status of the sponsor: Indication of whether the sponsor is
affected by the environmental effects of the proposal. commercial or non-commercial.

Standard care: Treatment regimen or medical Status: See Recruitment status.
management based on state of the art participant care.
Stem cells: Stem cells are different from other cells of the
Standard deviation (SD): Indicator of the relative body in that they have the ability to differentiate into other
variability of a variable around its mean; the square root of cell/tissue types. This ability allows them to replace cells

56 AlphaScienceLabs.com