Protocol Guides for HEY-Sponsored CTIMPS and non-CTIMPS

These are guides to writing a protocol for clinical trials sponsored by Hull and East Yorkshire Hospitals NHS Trust. There is a protocol guide for a clinical trial involving an investigational medicinal product (CTIMP protocol guide) and a guide for clinical trials not using medicines (non-CTIMP protocol guide). The aim of the guides are to help researchers with points to consider for the content of protocols.  Using the guides should reduce the number of queries raised by the Ethics Committee and MHRA during their review of the trial. This is the expected standard for Trust R&D approval.