Â鶹´«Ã½ÊÓƵÍøÕ¾

SOPs and guidance relevant to CI’s for studies (other than ATIMPs, CTIMPs and medical device studies) which are sponsored by Â鶹´«Ã½ÊÓƵÍøÕ¾ or Â鶹´«Ã½ÊÓƵÍøÕ¾H 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 Â鶹´«Ã½ÊÓƵÍøÕ¾ and Â鶹´«Ã½ÊÓƵÍøÕ¾H (Last updated 11/12/2023)Ìý

• Guidance for Researchers: JRO Peer Review Requirements for Â鶹´«Ã½ÊÓƵÍøÕ¾/Â鶹´«Ã½ÊÓƵÍøÕ¾H Sponsorship
• Â鶹´«Ã½ÊÓƵÍøÕ¾ Insurance Registration Form
• Risk Assessment (CTIMPs & non-CTIMPs)

Standard Operating Procedure for JRO Administration of Research PassportsÌý(Last updated 11/12/2023)

Â鶹´«Ã½ÊÓƵÍøÕ¾ Complaints from Research Subjects About Â鶹´«Ã½ÊÓƵÍøÕ¾ Sponsored StudiesÌýand TrialsÌýpolicyÌý

Protocol templates for Â鶹´«Ã½ÊÓƵÍøÕ¾/Â鶹´«Ã½ÊÓƵÍøÕ¾H sponsored research

• Â鶹´«Ã½ÊÓƵÍøÕ¾/Â鶹´«Ã½ÊÓƵÍøÕ¾HÌýObservational protocol template
• Â鶹´«Ã½ÊÓƵÍøÕ¾/Â鶹´«Ã½ÊÓƵÍøÕ¾HÌýInterventional studiesÌýprotocol template
• Â鶹´«Ã½ÊÓƵÍøÕ¾/Â鶹´«Ã½ÊÓƵÍøÕ¾HÌýData 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: