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  • Accessible record

    In the context of the Data Protection Act 1998, an 'accessible record' means:

    a) a health record which is any record that:

    i. consists of information relating to the physical or mental health or condition of an individual, and

    ii. has been made by, or on behalf of, a health professional in connection with the care of that individual

    b) an educational record

    c) an accessible public record

     

  • 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. freezer failure resulting in the 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 the 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. Please note that NHS RECs do not require notification of non-substantial amendments.

    Please see Protocol amendments for more information.

     

  • Anonymised data / information

    Anonymised data are data prepared from personal information, but from which the person cannot be identified by the recipient of the information. The term is used within the Data and Tissues Tool Kit when referring to robustly pseudonymised / linked anonymised 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 research 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(s) 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 Archiving Research Scenario for more guidance.

     

  • 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 requirements.

    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 participant 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 by those conducting the research 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'.

     


Glossary