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Glossary

S

  • Scottish MREC

    The Research Ethics Committee able to give ethical opinions on studies involving adults not able to consent for themselves in Scotland.

  • Screening

    Screening is a process, usually preceded by consent, in which members of a population are tested to identify those individuals who are suitable for inclusion in a study.

  • Serious Adverse Event (SAE)

    A serious adverse event is an untoward occurrence that:results in deathis life-threateningrequires hospitalisation or prolongation of existing hospitalisationresults in persistent or significant disability or incapacityconsists of a congenital anomaly or birth defectis otherwise considered medically significant by the investigator

  • Significance

    There is a difference between statistical and clinical significance. Statistical significance means that a discovered difference between populations could not have occurred by chance alone. Clinical significance is largely a matter of judgement e.g. the difference between populations may be statistically significant but, if the difference isn't worth achieving, not clinically significant. Differences may be found to be statistically significant, but of no clinical significance.

  • Site Specific Assessment (SSA)

    Site Specific Assessment

  • Site Specific Information (SSI)

    Site Specific Information form

  • Source Data Verification (SDV)

    Source data verification (SDV) is a check that the data collected on a research study (e.g. on a CRF or in a database) can be verified by looking at a primary data source (e.g. medical record): checking for consistency and accuracy in transcribing data from one place to another. Auditors will often wish to see SDV documented when the risks involved indicate it should be used.

  • Sponsor

    The sponsor is the individual, organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project. Responsibilities are defined by the UK policy framework for health and social care research and by the Clinical Trial Regulations.

  • Stem cells

    Immature cells that have not yet developed into specialized cells.  They are found throughout the human body: in early embryos (embryonic stem cells) and in adulthood.  Stem cells can be considered to be medicinal products or investigational medicinal products, if they are being presented as exerting principally a pharmacological, immunological or metabolic action.

  • Summary of Product Characteristics (SmPC)

    Summary of Product Characteristics (associated with a marketing licence for a drug)

  • Support departments

    Departments, often service departments with the NHS, which provide input into the conduct of a research project by providing a specific service i.e. Pharmacy, as opposed to a collaborating department which provide intellectual input into study design and /or interpretation.

  • Suspected Unexpected Serious Adverse Reaction (SUSAR)

    All suspected adverse reactions related to an investigational medicinal product (the tested investigational medicinal products and comparators) which occur in the concerned trial, and that are both unexpected and serious. For more detailed guidance please see Clinical Trials Tool Kit.


Glossary