Documents required for University-sponsored studies and hosted studies (with a non-commercial/commercial sponsor)
|IRAS full dataset (for HRA REC applications)|
|CUREC application forms (if applying to Medical Sciences IDREC)|
|Participant information sheet|
|Informed consent form|
|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|
|Statement of activities (SoA) and schedule of events (SoE) forms (see HRA website)|
|Non-NHS SSI form (if required)|
The HRA will require you to send additional relevant documentation:
- sponsorship letter (including a statement on insurance indemnity)
This will be supplied by CTRG following sponsorship review and is sent to the REC used for study approval.
- non-NHS SSI form (if required – generated from IRAS full dataset)
One form per site must be submitted to the REC local to that site for site approval.
For studies led from England with NHS involvement in England, a statement of activities and a schedule of events should be submitted with the application for HRA approval. Further information can be found on the HRA website.
This is required if there is NHS involvement outside England in the research and is generated from the IRAS full dataset. SSI forms must be submitted as part of the application for NHS permission for all NHS sites and for all study types.
All site-specific assessments (SSAs) for non-NHS sites are undertaken by the main REC carrying out the ethical review of the research ethics application. CTRG requires all study documents (see 'sponsorship review' above) for review before authorising your non-NHS SSI form and prior to submission into the REC.
If a non-NHS site is added to a clinical trial of an investigational medicinal product (CTIMP) after the ethical opinion for the main application has been given, a notice of substantial amendment, SSA and associated documents need to be submitted in the first instance to CTRG for authorisation, and then to the main research ethics committee (REC) for review and approval.
If a non-NHS site is added to a non-CTIMP at this stage, SSA and associated documents need to be submitted to CTRG. Following authorisation by CTRG only the SSA documents only need to be submitted to the main REC.
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. CTRG staff will be able to identify which SOPs are required for your study.