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SOPs and guidance relevant to CI鈥檚 for ATIMPs, CTIMPs and medical device studies which are sponsored by 麻豆传媒视频网站 and managed through the JRO (only).
SOP for granting 麻豆传媒视频网站 sponsorship听
SOP for the preparation and maintenance of the TMF and ISF听(Updated 5 August 2024)
JRO IMP Pharmacy Site File Review Checklist听(Updated 5 August)
JRO IMP Pharmacy Site File Index听(Updated 5 August 2024)
JRO TMF Review Checklist听(Updated 5 August 2024)
JRO TMF Index听(Updated 5 August 2024)
JRO ISF Review Checklist听(Updated 5 August 2024)
JRO ISF Index听(Updated 5 August 2024)
SOP for obtaining REC, CTA & HRA for CTIMPs
SOP for creating and maintaining an听IB听
SOP for preparation for randomisation blinding and code breaks听(Updated 13 August 2024)
SOP on training for staff 听participating in CTIMPs Sponsored by 麻豆传媒视频网站
SOP for the Recording, Management and Reporting of Adverse Events by InvestigatorsSOP for the oversight and monitoring of 麻豆传媒视频网站 sponsored CTIMPs
SOP for Recording and Reporting of Deviations, Violations, Serious Breaches and Urgent Safety Measure听[updated 3 July 2024]
SOP for the classification, review and submission of Amendments听(Updated 5 August 2024)
SOP for End of Trial Notification听
SOP for Archiving听
Protocol templates for 麻豆传媒视频网站听sponsored research
麻豆传媒视频网站 CTIMP protocol template (provided by JRO Clinical Trials team as part of sponsorship submission)
麻豆传媒视频网站 Advanced therapy trials protocol template (provided by JRO ATIMPs team as part of sponsorship submission)
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 麻豆传媒视频网站听(Last updated 11/12/2023)听
Standard Operating Procedure for JRO Administration of Research Passports听(Last updated 11/12/2023)
麻豆传媒视频网站 Complaints from Research Subjects About 麻豆传媒视频网站 Sponsored Studies听and Trials听policy