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• Adverse event / incident

  An adverse event or incident is any undesirable occurrence on a particular study.

  In relation to a study participant, it can be described as any unfavourable and unintended sign, symptom or disease temporally associated with participation in the research project.

  The term has also been used to describe unfortunate events that may have serious consequences for the research project, e.g. breaking down of a freezer and loss of tissue samples.

   

• Amendment

  A change made to the terms of the Research Ethics Committee (REC) application, the protocol or any supporting documentation after the study has started. A study is normally considered to start after the commencement of any protocol procedures. Amendments can be 'substantial' or 'non-substantial’.

  Substantial amendments
  

  These require the issue of a favourable opinion from the main REC and NHS R&D departments. If the amendment has implications for study in terms of the scientific peer review, the funding body should also be consulted.

  Non-substantial amendments

  The REC, NHS R&D departments (if appropriate) and sponsor(s) may require notification of non-substantial amendments. NHS RECs do not require notification of non-substantial amendments.

  For more information please see the Protocol amendments station in the Data and Tissues Tool Kit.

   

• Anonymised data / information

  Anonymised data are data prepared from information from which the person to whom is relates cannot be identified. The term is used when referring to robustly pseudonymised / linked data or unlinked anonymised data.

  Pseudonymised data, also referred to as linked anonymised

  This is anonymous to the people who receive and hold it (e.g. a research team), but contains information or codes that would allow others (e.g. those responsible for the individual’s care) to identify an individual from it.

  Unlinked anonymised data, or truly anonymised data

  This contains no information that could reasonably be used, by anyone, to identify the individual or study participant.

   

• Anonymised tissue

  The Human Tissue Authority consider that tissue is anonymised if the researcher is not in possession, and is not likely to come into possession, of information from which the individual can be identified. This does not mean that samples must be permanently unlinked, and coding samples meets these requirements.

   

• Archiving

  The retention of valuable research data which may have secondary use, or may be analysed further to verify results or as part of a meta-study; and the retention of study files which demonstrate the compliance of the investigator and sponsor with GCP and regulatory requirements.

  During archiving it should be ensured that data are properly selected, stored, can be accessed and that logical and physical integrity are maintained over time, including security and authenticity.

  Periods of retention will depend on the nature of the research and sponsor’s and funder’s requirements. Please see the Research Scenarios section of the Data and Tissues Tool Kit for more guidance on this area.

   

• Audit

  A systematic and independent examination of study-related activities and documents, to determine whether the evaluated study-related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor's standard operating procedures (SOP’s), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

  The Department of Health’s minimum standards for research governance state that at least 10% of projects should be routinely audited. Audit should look at areas such as: protocol amendments, start and stop dates, changes to inclusion/exclusion criteria, changes to the consent procedure, changes to recruitment, funding, research team or the patient information sheet, approvals for amendments, adverse events, health and safety, intellectual property, subject logs, recruitment, consent, and changes to data management.

  A distinction should be made between monitoring and auditing. All research activity should be monitored routinely. In addition, an organisation should conduct formal audit of a selection of research projects/activity.

   

• Authorisation

  The Human Tissue Act 2004 uses the term ‘consent’, whereas the Human Tissue (Scotland) Act 2006 uses the term ‘authorisation’.