After you have gained the necessary approvals and secured funding, you are ready to start your project. This section outlines key responsibilities during the life of your study to ensure your research is not interrupted and is not in breach of any regulations.
Your roles and responsibilities
We expect all members of the research team to conduct their projects to a high standard and to maintain strong governance throughout the life of the study.
The Chief Investigator (CI) is the researcher with overall responsibility for the conduct and management of the study at all sites.
The Principal Investigator (PI) has responsibility for the conduct and management of a study at a particular site. All research must be conducted in line with the approved protocol, Trust policy, and national frameworks.
When you complete your IRAS form when applying for approval, you would have officially signed off on a list of responsibilities for conducting your research study and agreed to adhere to them.
Starting your study
Investigators are expected to start their study soon after Trust approval is issued and recruit the first participant within 70 days for all clinical trials.
When developing your feasibility review and recruitment plan, your Research Support Officer would have explained the Department of Health benchmark, designed to promote readiness and swiftness by measuring the time taken to recruit the first participant to studies at each site, and to identify best practices and barriers to conducting research in the UK (see Time and Target page).
You must report when you have recruited your first participant by uploading all accrual to EDGE. This is reported as part of our national benchmarks on research performance, as required by the National Institute for Health Research (NIHR).
For further details about EDGE please contact your Research Support Officer.
How to report breaches and concerns
All staff have a duty of care toward our patients and are encouraged to report their concerns.
- all Good Clinical Practice breaches
- any instances of poor practice or misconduct
- Serious Unexpected Incidents (SUI)
These issues must be registered on the Trust’s Datix system and can also be reported to:
- your sponsor
- your local governance meeting
- or the Research and Innovation team.
All allegations will be investigated by the Trust’s Governance lead, Research and Innovation manager and the relevant Research and Innovation lead. Outcomes of an investigation can include suspension of work, destruction of data, and disciplinary action, as described in the Trust Policy on Research Conduct and Misconduct.
Making changes to your study
If you make any changes to the documentation for your study, they must be registered with the Research and Innovation team, especially your research protocol. Any unreported changes would lead to a governance breach and the Research and Innovation team would then need to carry out a compliance review and audit.
For further guidance on reporting amendments to your study, please see the HRA website.
You will need to provide annual progress reports as a condition of the approval from the Research Ethics Committee (REC). You will be prompted by the REC and will be required to complete and submit your report, and to supply a copy to the Research and Innovation team. You will need to notify the Research and Innovation team when recruitment is complete.
Our Trust will monitor performance to avoid any risk to reputation if the project is not delivered. This may jeopardise future funding and contribute towards financial penalties to the Trust. You will be contacted regularly to provide information relating to your project, such as recruitment figures, publications or other outputs of your work, such as changes to clinical practice.
Further support and guidance
Please keep in touch with the Research and Innovation team throughout your research for regular advice on how to:
- amend your protocol and paperwork and notify the relevant REC and HRA
- ensure all researchers involved meet the latest training requirements
- report recruitment figures to UKCRN and EDGE.