SOPs and guidance relevant to CI’s for studies (other than ATIMPs, CTIMPs and medical device studies) which are sponsored by ¹û¶³Ó°Ôº or ¹û¶³Ó°ÔºH 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 ¹û¶³Ó°Ôº and ¹û¶³Ó°ÔºH (Last updated 11/12/2023)Ìý
- Guidance for Researchers: JRO Peer Review Requirements for ¹û¶³Ó°Ôº/¹û¶³Ó°ÔºH Sponsorship
- ¹û¶³Ó°Ôº Insurance Registration Form
- Risk Assessment (CTIMPs & non-CTIMPs)
Standard Operating Procedure for JRO Administration of Research PassportsÌý(Last updated 11/12/2023)
¹û¶³Ó°Ôº Complaints from Research Subjects About ¹û¶³Ó°Ôº Sponsored StudiesÌýand TrialsÌýpolicyÌý
Protocol templates for ¹û¶³Ó°Ôº/¹û¶³Ó°ÔºH sponsored research
- ¹û¶³Ó°Ôº/¹û¶³Ó°ÔºHÌýObservational protocol template
- ¹û¶³Ó°Ôº/¹û¶³Ó°ÔºHÌýInterventional studiesÌýprotocol template
- ¹û¶³Ó°Ôº/¹û¶³Ó°ÔºHÌýData 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: