How to guide: Delegation of duties log (or delegation log)

Key information you should be aware of:

The delegation log (stored in the Site File, usually alongside research CVs and GCP certificates) is a list of study-related duties assigned to staff members It is a live document which must be kept up to date if staff working on the study change roles or leave etc. The Principal Investigator is responsible for duties carried out in connection with the study, but the delegation log enables them to delegate some specified duties to other staff. Staff members must only carry out duties to which they are assigned on the delegation log. Please note that some very simple studies (e.g. surveys) may not have a delegation log. If in doubt, staff should always check with the study team before handling any study-related task.

  • The practice is responsible for ongoing treatment for its patients, and for ensuring that patients and patient data are treated with due care.
  • Most studies will require that a PI be appointed at the practice. PIs are responsible for the conduct of a specific study at each research site (e.g. the GP practice). Tasks may be delegated but responsibility remains with the PI.
  • Many studies require that staff who will be involved in recruiting participants and receiving consent must have completed NIHR Good Clinical Practice (GCP) training. Check the protocol and/or with the study team for clarification.
  • NHS R&D departments and the RDN are responsible for advising practices with regard to their participation in research.
  • The practice is responsible for ensuring that all staff who may be involved in a study have an understanding of what this involves. The study team will ensure any study specific training is provided (this should be detailed in the OID).
  • The Clinical Negligence Scheme for General Practice is responsible for providing insurance for negligence in the delivery of research. The Sponsor insurance is responsible for insuring any problems with the design of the research.
  • Sponsors are responsible for the initiation, management and financing of a specific study.
  • Chief Investigators are responsible for the conduct of a specific study within the UK.

View additional site selection/initiation visit (SIV) guides

Full guide

Delegation of duties log (or delegation log)

  • A delegation log should exist for studies, apart from very simple studies (e.g. surveys).
  • Blank delegation logs are usually supplied by the study team as part of the Investigator Site File (ISF).  As an example, a template to a delegation log is available here: https://myresearchproject.org.uk/help/help%20documents/Signature_And_Delegation_Log_Template_v1-2.docx
  • The name of each staff member who will carry out a study-related task must appear on the delegation log. Alongside their name, the reference for the specific task(s) should be clearly marked. This should be initialled by the staff member and signed and dated by the PI.
  • The PI is responsible for ensuring that any staff member listed on the delegation log is sufficiently trained, qualified and/or experienced to carry out the task to which they are assigned.
  • The delegation log should be kept up to date, with start and end dates for staff that have been assigned and/or relieved of specific tasks. An end date should be entered if a staff member leaves the practice.
  • Some study teams may ask for up to date copies of the delegation log. This should be sent promptly when requested.
  • Additional pages of a delegation log should be clearly marked as such so that it is clear how many pages there are (e.g. 1 of 3).
  • As with all research documentation, any corrections on the delegation log should be marked with one straight line through the error. The person making the correction should initial and date the correction. Nothing should be deleted by being marked illegible or with correction fluid.

Glossary of Acronyms and Terms

  • NIHR – National Institute for Health Research
  • RDN – Research Delivery Network
  • GCP – Good Clinical Practice training
  • ISF – Investigator Site File (or Site File)
  • OID – Organisational Information Document
  • SIV – Site Initiation Visit
  • SOPs – Standard Operating Procedures
  • AEs – Adverse Events
  • PI – Principal Investigator
  • CI – Chief Investigator

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