Sponsored Clinical Trial of an Investigational Medicinal Product (CTIMP)

For reference, links are included for: CUH SOPs and CUH Document Library

Title of Document	Reference Number	Date ratified
CPFT SOP 001 Delegation of roles and responsibilities for CTIMPS.pdf	CPFT/SOP001	13/09/2018
CPFT SOP 002 Quality Assurance Audits	CPFT/SOP002	13/09/2018
CPFT SOP 003 Serious Breach of Protocol or GCP in CTIMPs	CPFT/SOP003	13/09/2018
CPFT SOP 005 Management of contracts for research projects	CPFT/SOP005	13/09/2018
CPFT SOP 006 GCP Training for Clinical staff	CPFT/SOP006	13/09/2018
CPFT SOP 008 Unblinding in an emergency situation	CPFT/SOP008	13/09/2018
CPFT SOP 009 Preparing for and Facilitating a Regulatory -MHRA- Inspection	CPFT/SOP009	13/09/2018
CPFT SOP 012 Facilitating Monitoring Visits for Clinical Trials at CPFT	CPFT/SOP012	13/09/2018
CPFT GD 008 Review of SAE Line Listing by Academic Research Leads	R&D/GD008	N/A
CPFT GD 009 Research Personnel Curriculum Vitae (CV)’s Guidance	R&D/GD009	N/A
CPFT Misconduct Policy	P153	05/09/2018
CPFT RD Review and set up process for confirming capacity and capability	P156	05/09/2018
IP Policy CPFT - Version 2 1	P154	05/09/2018
RP Policy CPFT - Version 2.1	N/A	05/09/2018