SOPs for the management, in-progress and close down of all UCLH studies

SOP for Definition of Responsibilities

• UCLH study delegation log template
• UCLH guide for approved responsibilities of site staff

SOP for Reporting Amendments

SOP for Reporting and Managing Incidents and Events in Research

Reference safety information (RSI) hints and tips sheet

SOP for Essential Documents and the Study File (TMF/ISF)

• UCLH Site File Index Checklist

SOP for Study Close Down

• Study Close Down Checklist for UCLH-Hosted Studies

SOP for Non-commercial study archiving of Investigator Site File and Pharmacy Site File

• JRO Research Records Transfer Form

SOP for Procedure for the review and approval of  Early-Phase 1/2a Clinical Trials or research studies with an Experimental Medicine Component at UCLH

SOP for Commercial Archiving (further details to follow. For more information, contact uclh.randd@nhs.net )

For all UCLH-hosted research, please refer to the UCLH ‘Consent to Participation in Research’ Policy which is available via myUCLH