SOPs and guidance relevant to CI’s for studies (other than ATIMPs, CTIMPs and medical device studies) which are sponsored by UCL or UCLH and managed through the JRO (only).
SOP for Reporting Research Incidents and Events in non-CTIMPs
- AE Log
- SAE Log
- Protocol Deviation Log
- Protocol Violation Log
- Participant Screening Log
- Participant Enrolment/Withdrawal/Completion Log
SOP for Peer Review for studies sponsored by UCL and UCLH (Last updated 11/12/2023)Ìý
- Guidance for Researchers: JRO Peer Review Requirements for UCL/UCLH Sponsorship
- UCL Insurance Registration Form
- Risk Assessment (CTIMPs & non-CTIMPs)
Standard Operating Procedure for JRO Administration of Research PassportsÌý(Last updated 11/12/2023)
UCL Complaints from Research Subjects About »Ê¼Ò»ªÈË Sponsored StudiesÌýand TrialsÌýpolicyÌý
Protocol templates for UCL/UCLH sponsored research
- UCL/UCLHÌýObservational protocol template
- UCL/UCLHÌýInterventional studiesÌýprotocol template
- UCL/UCLHÌýData only studies
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: