Conducting your research
After you have gained all of your approvals and secured your funding, you are ready to start your project. If you have not got all of your approvals yet but wish to prepare for your study launch, there are some things that you can do without approval. Please see our Readying for speedy recruitment guidance for more details.
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.
Roles and responsibilities
All members of the research team are expected to conduct projects to a high standard and to maintain strong governance throughout the life of the study. The chief investigator is the researcher with overall responsibility for the conduct and management of the study at all sites, while the principal investigator 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.
Commencing your study
Investigators are expected to start the study soon after Trust approval is issued and recruit the first participant within 70 days for all clinical trials. In the initial planning stage, when developing your feasibility review and recruitment plan, your Research Facilitator 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.
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 the Research Data Officer Nayab Chaudhury or Research Data Assistant Mohammed Sadiqur Rahman on firstname.lastname@example.org.
Reporting breaches and concerns
All staff have a duty of care toward our patients and are encouraged to report their concerns.
- all Good Clinical Practice breeches
- any instances of poor practice or misconduct
- Serious Unexpected Adverse Reactions (SUSARs)
- Adverse Incidents (AIs).
These issues must be registered on the Trust Datix system and can also be reported to:
- your sponsor
- your local governance meeting
- or the Research Office.
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.
Changes to your study
Any changes to documentation need to be registered with the Research Office, especially your research protocol. Any unreported changes would lead to a governance breach and the R&D 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.
Updates on progress
A condition of research ethics committee approval is to provide annual progress reports. You will be prompted by the REC that reviewed your project and will be required to complete and submit your report, and to supply a copy to the Research Office. You will need to notify us when recruitment is complete.
The Trust will also 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
Keep in touch with the Research Office 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.