SOPs and guidance relevant to CI’s for ATIMPs, CTIMPs and medical device studies which are sponsored by UCL and managed through the JRO (only).
SOP for granting UCL sponsorship
SOP for the preparation and maintenance of the TMF and ISF (Updated 5 August 2024)
JRO IMP Pharmacy Site File Review Checklist (Updated 5 August)
JRO IMP Pharmacy Site File Index (Updated 5 August 2024)
JRO TMF Review Checklist (Updated 5 August 2024)
JRO TMF Index (Updated 5 August 2024)
JRO ISF Review Checklist (Updated 5 August 2024)
JRO ISF Index (Updated 5 August 2024)
SOP for obtaining REC, CTA & HRA for CTIMPs
SOP for creating and maintaining an IB
SOP for preparation for randomisation blinding and code breaks (Updated 13 August 2024)
SOP on training for staff participating in CTIMPs Sponsored by UCL
SOP for the Recording, Management and Reporting of Adverse Events by InvestigatorsSOP for the oversight and monitoring of UCL sponsored CTIMPs
SOP for Recording and Reporting of Deviations, Violations, Serious Breaches and Urgent Safety Measure [updated 3 July 2024]
SOP for the classification, review and submission of Amendments (Updated 5 August 2024)
SOP for End of Trial Notification
SOP for Archiving
Protocol templates for UCL sponsored research
UCL CTIMP protocol template (provided by JRO Clinical Trials team as part of sponsorship submission)
UCL Advanced therapy trials protocol template (provided by JRO ATIMPs team as part of sponsorship submission)
Lab index and feasibility questionnaire templates
Templates for supporting documents
The package of supporting documents you will need to provide will depend on the type of application and the type of research activity that is planned. Supporting documents include:
SOP for Peer Review for studies sponsored by UCL (Last updated 11/12/2023)
Standard Operating Procedure for JRO Administration of Research Passports (Last updated 11/12/2023)
UCL Complaints from Research Subjects About UCL Sponsored Studies and Trials policy