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SOPs and guidance relevant to CI’s for studies (other than ATIMPs, CTIMPs and medical device studies) which are sponsored by ×î×¼µÄÁùºÏ²ÊÂÛ̳ or ×î×¼µÄÁùºÏ²ÊÂÛ̳H 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 ×î×¼µÄÁùºÏ²ÊÂÛ̳ and ×î×¼µÄÁùºÏ²ÊÂÛ̳H (Last updated 11/12/2023)Ìý

• Guidance for Researchers: JRO Peer Review Requirements for ×î×¼µÄÁùºÏ²ÊÂÛ̳/×î×¼µÄÁùºÏ²ÊÂÛ̳H Sponsorship
• ×î×¼µÄÁùºÏ²ÊÂÛ̳ Insurance Registration Form
• Risk Assessment (CTIMPs & non-CTIMPs)

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

×î×¼µÄÁùºÏ²ÊÂÛ̳ Complaints from Research Subjects About ×î×¼µÄÁùºÏ²ÊÂÛ̳ Sponsored StudiesÌýand TrialsÌýpolicyÌý

Protocol templates for ×î×¼µÄÁùºÏ²ÊÂÛ̳/×î×¼µÄÁùºÏ²ÊÂÛ̳H sponsored research

• ×î×¼µÄÁùºÏ²ÊÂÛ̳/×î×¼µÄÁùºÏ²ÊÂÛ̳HÌýObservational protocol template
• ×î×¼µÄÁùºÏ²ÊÂÛ̳/×î×¼µÄÁùºÏ²ÊÂÛ̳HÌýInterventional studiesÌýprotocol template
• ×î×¼µÄÁùºÏ²ÊÂÛ̳/×î×¼µÄÁùºÏ²ÊÂÛ̳HÌýData 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: