Documents required
Resources for the preparation for a clinical trial or clinical research project
Documents required for University-sponsored studies and hosted studies (with a non-commercial/commercial sponsor)
-
IRAS full dataset (for HRA REC applications)
(if project is not peer reviewed as part of funding application)
- Principal/chief investigator CV
- GP letter (if applicable)
- Advertisement(s) including posters and texts of email or radio adverts (if applicable)
- Any other media text used to provide information to participants (eg reminder texts/emails)
- Study-specific documents (eg questionnaires, web-based tools)
- Investigator’s brochure (IB – for unlicensed IMPs) or summary of medicinal product characteristics (SmPC – for marketed IMPs) if research involves drug administration
- Confirmation of funding (evidence of external funding confirmation and for internal funding from department)
- UK local information pack (see HRA website)
- Non-NHS/HSC site assessment form (if required)
- Organisation information document guidance
The HRA will require you to send additional relevant documentation:
- sponsorship letter (including a statement on insurance indemnity)
This will be supplied by the Research Governance, Ethics & Assurance Team following sponsorship review and is sent to the REC used for study approval. - UK local information pack
This is required for studies involving the NHS/HSC in the UK. Further information can be found on the HRA website - non-NHS/HSC site assessment form only for clinical trials of investigational medicinal products (CTIMPs) and clinical investigations of medical devices – see HRA announcement of changes to the application process and IRAS information on non-NHS/HSC sites for details
For clinical trials of investigational medicinal products (CTIMPs) and clinical investigations of medical devices carried out on University premises (eg OCMR, FMRIB, CCVTM, OCDEM) a non-NHS/HSC site assessment form may be required. Contact the Research Governance, Ethics & Assurance Team for advice.
All site-specific assessments (SSAs) for non-NHS/HSC sites are undertaken by the main REC carrying out the ethical review of the research ethics application. The Research Governance, Ethics & Assurance Team requires all study documents (see 'sponsorship review' above) as well as the site assessment form for review before authorisation and submission to the REC.
If a non-NHS/HSC site is added to a clinical trial of an investigational medicinal product (CTIMP) or clinical investigation of a medical device after the ethical opinion for the main application has been given, a notice of substantial amendment, site assessment form and associated documents need to be submitted in the first instance to the Research Governance, Ethics & Assurance Team for authorisation, and then to the main research ethics committee (REC) for review and approval.
Standard operating procedures (SOPs) must be in place prior to recruitment of the first participant.
They should cover the range of activities involved in the research and ensure that practice is standard, regardless of who is carrying out the activity.
All research staff must be trained in the activities for which they are responsible and a clear concise SOP will guide anyone unused to that particular procedure.
Where they exist, University core SOPs should be used for all clinical trials sponsored by the University, and for clinical research where appropriate.
Other template SOPs can be adapted by individual investigators or departments. Staff in the Research Governance, Ethics & Assurance Team will be able to identify which SOPs are required for your study.
