Contents
1 Background
All research carried out at Rotherham, Doncaster and South Humber NHS Foundation Trust (RDaSH NHS FT) must have a site file which contains essential documents. The principal investigator (PI) has overall responsibility for the proper conduct of the study on this site. However, duties may be delegated to appropriately qualified staff, this must be recorded on the delegation log which forms part of the site file (see investigator site file SOP).
A study duty is any task essential to the research delivery that is documented in a study protocol, where that activity needs to be delegated to a specific person or role. A delegation of study duties log records all delegated duties and the staff they are delegated to.
2 Aim
To ensure all research projects within RDaSH NHS FT maintain an up-to date delegation log within the site file. This SOP has been produced in accordance with International Community of Harmonisation (ICH) or Good Clinical Practice (GCP) Guidelines and UK Framework for Health and Social Care Research 2017.
3 Scope
All staff internal and external to RDaSH NHS FT who are acting as principal investigator on a research study or who will conduct delegated tasks.
4 Link to overarching policy and, or procedure
5 Procedure or implementation
5.1 Knowledge, training, and experience
The PI will ensure the appropriateness of the personnel undertaking the duties, by ensuring that up to date curriculum vitae (CV) of all personnel reflect requisite skills and education. The CVs of staff involved in research (for example, research nurses, clinical studies officers, medical staff, research associates and study administrators) must be filed in the investigator site file. The research governance manager will work with the PI to agree training requirements for different study types and study roles.
The PI must provide appropriate training or provide access to appropriate training for delegated duties. The Grounded Research team can provide advice on accessing appropriate training.
The PI has a responsibility to ensure prior to the delegation of a study duty, that the study personnel concerned have a good knowledge and understanding of the trial protocol (and investigational product, where applicable) and are competent to undertake the delegated task.
Where study specific training is required an up-to-date training record must be kept in the investigator site file to evidence that appropriate training has been provided to staff with delegated duties.
All personnel involved in the clinical research must practice within their own code of professional conduct. Study duties must not jeopardise professional practice and accountability.
5.2 Procedure
The PI must comply with section 4.1.5 of ICH or GCP which specifies a list, which is kept in the investigator site file. The list should identify all the suitably qualified persons to whom the PI has delegated significant trial related duties (appendix A specimen delegation of study duties log).
The sponsor of the study at the time of study set up may agree with the PI the duties to be delegated. The range of duties to be delegated will vary between sponsors some sponsors will allow more flexibility than others.
The PI records the study personnel and the duties delegated to them on the delegation of study duties log, which is filed in the investigator site file.
All personnel accepting a delegated duty sign and record each duty accepted from those identified on the delegation of study duties log.
The PI must sign and date to validate all entries to the delegation of study duties log.
The PI will update and amend the delegation of study duties log if delegated duties or personnel change during the course of a study.
At the end of a study the PI will sign and date the delegation of study duties log to confirm end of study activity.
6 Appendices
6.1 Appendix A
Document control
- Version: 2.
- Unique reference number: 437.
- Approved by: Corporate policy approval group.
- Date approved: 20 May 2021.
- Name of originator or author: Research governance manager.
- Name of responsible individual: Research panel.
- Date issued: 28 May 2021.
- Review date: May 2024.
- Target audience: All staff involved in research.
Page last reviewed: April 15, 2024
Next review due: April 15, 2025