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SOPs for UCL and UCLH sponsored CTIMPs

SOPs and guidance relevant to CI’s for ATIMPs, CTIMPs and medical device studies which are sponsored by UCL or UCLH and managed through the JRO (only).

SOP for granting UCL sponsorship 

SOP for the preparation and maintenance of the TMF and ISF

SOP for obtaining REC, CTA & HRA for CTIMPs

SOP for creating and maintaining an IB 

SOP for preparation for randomisation blinding and code breaks 

SOP on training

SOP for AE and SAE Reporting by Investigators

SOP for the oversight and monitoring of UCL sponsored CTIMPs

SOP for Recording and Reporting of Deviations, Violations, Serious Breaches and Urgent Safety Measure 

SOP for the classification, review and submission of Amendments 

SOP on DSUR

SOP for End of Trial Notification 

SOP for Archiving 

SOP for Electronic Signature 

Protocol templates for UCL/UCLH 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)

  • UCL/UCLH Medical device trial protocol templates (CE marked, non-CE marked, in-house health exemption studies) – coming soon

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 and UCLH 

Standard Operating Procedure for JRO Administration of Research Passports

UCL Complaints from Research Subjects About UCL Sponsored Studies and Trials policy