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  • Safe Haven

    All secure points at which confidential information is received.  Organisations should ensure that there are procedures in place to ensure that personal information is received to a secure and protected point. All points of receipt should be considered i.e. transcribing of phone messages, fax in-trays, electronic mailboxes, pigeon holes and in-trays for paper information etc.

     

  • Secondary data

    Data derived from use or analysis of primary data.  Often gathered or created by someone other than the primary data creator.  Secondary data can be generated for purposes different from those of the original research that produced the primary data.

     

  • Secondary use

    Secondary use is where any data generated as the result of a research study is used for a purpose different from those of the original research.  Secondary use can use both primary and/or secondary data.

     

  • Sensitive information

    Information that when used incurs a need for extra care, e.g. information about mental health, sexuality and other areas where revealing confidential information is especially likely to cause embarrassment or discrimination. According to the Data Protection Act 1998 'sensitive personal data' (defined below) includes all information about physical as well as mental health or condition, or sexual life.

     

  • Sensitive personal data

    In the context of the Data Protection Act 1998 'sensitive personal data' means personal data consisting of information as to:

    a)  the racial or ethnic origin of the data subject,

    b)  his political opinions,

    c)  his religious beliefs or other beliefs of a similar nature,

    d)  whether he is a member of a trade union (within the meaning of the Trade Union and Labour Relations (Consolidation) Act 1992),

    e)  his physical or mental health or condition, 

    f)  his sexual life,

    g)  the commission or alleged commission by him of any offence, or

    h)  any proceedings for any offence committed or alleged to have been committed by him, the disposal of such proceedings or the sentence of any court in such proceedings.

     

  • Serious Adverse Event (SAE)

    In research other than CTIMPs, a Serious Adverse Event is defined as an untoward occurrence that:
    (a) results in death;
    (b) is life-threatening;
    (c) requires hospitalisation or prolongation of existing hospitalisation;
    (d) results in persistent or significant disability or incapacity;
    (e) consists of a congenital anomaly or birth defect; or
    (f) is otherwise considered medically significant by the investigator.
    (HRA website).


    The HTA describe a serious adverse event as 'an unintended response, including a communicable disease, in a donor of tissue or cells intended for human application or a recipient of tissue or cells, which may be associated with the procurement or human application of tissue or cells and which is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.’ (HTA website).

  • Source data verification (SDV)

    Source data verification (SDV) is a check that the data collected on a research study (e.g. on a case report form or in a database) can be verified by looking at a primary source (e.g. medical record). In essence, 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.

    Sometimes the research record will be the source data, e.g. for electronic questionnaire-based studies. In these situations mechanisms should be built in to ensure that checks are in place to minimise the chances of error when completing the questionnaire.

     

  • Sponsor

    The sponsor is the individual, or organisation (or group of individuals or organisations) that take on responsibility for confirming that there are proper arrangements in place to initiate, manage and monitor, and finance a study. Responsibilities are defined by the UK Health Departments' Research Governance Frameworks and by the Clinical Trial Regulations.

     

  • Subject access

    The right of data subjects to receive a copy of the information held about them, a description of why their information is being processed, and details of anyone who may see a copy of their data, to whom it may be transferred, and the logic involved in any automated decisions taken on the basis of that data. Under the Data Protection Act 1998 research exemption, data subjects do not have a right of access to research data.

     

  • System Level Security Policy (SLSP)

    The System Level Security Policy (SLSP) was a means by which organisations' provided assurance of their confidentiality and security arrangements on a study by study basis. This is now replaced by completion of the Information Governance Toolkit.




Glossary