Documents required for a valid application to R&D for Trust approval: 
Document	Received	Version number & date	Document(s) reviewed by	
Copy of the final IRAS Form
				
Copy of SoE / SoECAT  (non-commercial only)
				
Copy of ICT finalised budget (commercial only)				
Copy of finalised OID (commercial and non-commercial.  OID used as final contract for most Non-Commercial studies)				
Copy of delegation log				
CV for PI (valid for three years)				
HRA/REC approval letter with list of all REC approved documents 				
HRA/REC approval letter(s) for amendments approved prior to trust approval				
Latest HRA/REC approved versions:
Protocol, PIS and Consent form				

Finalised Clinical Trial Agreement (contract)/ funding arrangements				
Material Transfer Agreement if required (included within most contract templates)				
CTIMP/Non CE marked Device studies only		
MHRA approvals including amendments				
GCP certificate for PI (valid for 3 years)				
Other regulatory authority approvals e.g. GTAC, CAG, NOMS, ARSAC				

Checks to be undertaken by R&D Team prior to approval:
Action	Completed	Confirmed by 	
CV & GCP certificate for PI (valid for three years)			
Check a monitoring plan is in place			
Risk Assessment score calculated			
Directorate & service department  approvals received
CADs/TSMG/Pathology/Radiology/Pharmacy/Cardiology/Transplant/Surgery			
Information Asset Register completed / assigned			
EDGE governance workflow completed			
EDGE red level checks completed 			
All other outstanding actions resolved			
Regulatory / Sponsors Green Light issued: 									
Date	Signed	Name