Initial approvals required
You cannot initiate your study until all the relevant approvals and permissions have been obtained for your research these include:
- Internal College approvals
- Divisional/Departmental approvals
- RGIT approval
- Trust permission – if your research is conducted in NHS
- Divisional approval from feasibility team
- Imaging approval – If your research involve ionisation and radiation
- Pathology approval – If your study need pathology samples
- Pharmacy approval – If a drug or IMP is involved
- Research Ethics Committee (REC) approval
- Local ethics approvals
- Greenlight release in the form Study start approval form issued by RGIT monitors once the CCC is confirmed. This is only applicable for college sponsored CTIMP studies.
If NHS research then:
- Health Research Authority (HRA) approval
- Other applicable regulatory approvals such as
- Medicines and Healthcare Product Regulatory Agency (MHRA)
- Human Fertilisation and Embryology Authority (HFEA)
- Confidentiality Advisory Group (CAG)
- ARSAC approval – This includes study wide ARSAC and local site level ARSAC.
- NHS Trust R&D Confirmation of Capacity and Capability (CCC)
If your study is a clinical trial, as defined by the International Committee of Medical Journal Editors, or an interventional study as defined by the HRA then you should also register it on a public access database before you enrol your first participant. Some journals will not publish studies which have not been registered on a public database before enrollment of the first participant. For help with registration on clinicaltrials.gov or EudraCT, please contact the Research Integrity Officer.
If your research will involve collecting and processing of personal data including pseudonymised data, to ensure compliance with the General Data Project Regulations and Data Protection Act 2018, register the study on Research Data Privacy Impact Assessment (RDPIA) database.
Once you are confident you have all the necessary internal, regulatory and/or NHS Trust R&D Office Confirmation of Capacity and Capability for your project as appropriate and have registered it on a public access database (if it is a clinical trial as defined by the International Committee of Journal Editors) you can initiate your study.