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• Sensitive information

  Information that when used incurs a need for extra care, e.g. 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” includes all information about physical as well as mental health or condition, or sexual life.

   

• Serious advise event (SAE)

  The HTA describe a serious adverse event as any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissue and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients, or which might result in, or prolong, hospitalisation or morbidity.

  NRES define a serious adverse event as an untoward and unexpected occurrence that:

  1. results in death;
  2. is life-threatening;
  3. requires hospitalisation or prolongation of existing hospitalisation;
  4. results in persistent or significant disability or incapacity;
  5. consists of a congenital anomaly or birth defect.

   

• Source data verification

  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 takes on responsibility for confirming there are proper arrangements to initiate, manage and monitor, and finance a study. Responsibilities are defined by the Research Governance Frameworks and by the Clinical Trial Regulations.