Sponsored Clinical Trial of an Investigational Medicinal Product (CTIMP)

Here you can find R&D department SOPs for sponsored CTIMPs

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

 

 

The page was last updated on 05 November 2018 by jonathan.lewis.

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