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SOPs and guidance relevant to CI’s for ATIMPs, CTIMPs and medical device studies which are sponsored by ×î×¼µÄÁùºÏ²ÊÂÛ̳ and managed through the JRO (only).

SOP for granting ×î×¼µÄÁùºÏ²ÊÂÛ̳ sponsorshipÌý

• ×î×¼µÄÁùºÏ²ÊÂÛ̳ First Contact QuestionnaireÌý

• CTIMP Protocol Template

SOP for the preparation and maintenance of the TMF and ISFÌý(Updated 5 August 2024)

• JRO IMP Pharmacy Site File Review ChecklistÌý(Updated 5 August)

• JRO IMP Pharmacy Site File IndexÌý(Updated 5 August 2024)

• JRO TMF Review ChecklistÌý(Updated 5 August 2024)

• JRO TMF IndexÌý(Updated 5 August 2024)

• JRO ISF Review ChecklistÌý(Updated 5 August 2024)

• JRO ISF IndexÌý(Updated 5 August 2024)

SOP for obtaining REC, CTA & HRA for CTIMPs

SOP for creating and maintaining anÌýIBÌý

• ×î×¼µÄÁùºÏ²ÊÂÛ̳ JRO IB Template

SOP for preparation for randomisation blinding and code breaksÌý(Updated 13 August 2024)

• Code Break Log Template

SOP on training for staff Ìýparticipating in CTIMPs Sponsored by ×î×¼µÄÁùºÏ²ÊÂÛ̳

SOP for the Recording, Management and Reporting of Adverse Events by InvestigatorsSOP for the oversight and monitoring of ×î×¼µÄÁùºÏ²ÊÂÛ̳ sponsored CTIMPs

SOP for Recording and Reporting of Deviations, Violations, Serious Breaches and Urgent Safety MeasureÌý[updated 3 July 2024]

• SOP Log of Deviations, Violations, Potential Serious Breaches, Serious Breaches, Urgent safety measure

SOP for the classification, review and submission of AmendmentsÌý(Updated 5 August 2024)

SOP on DSUR

• DSUR template

SOP for End of Trial NotificationÌý

SOP for ArchivingÌý

SOP for Electronic SignatureÌý

Protocol templates for ×î×¼µÄÁùºÏ²ÊÂÛ̳Ìýsponsored research

• ×î×¼µÄÁùºÏ²ÊÂÛ̳ CTIMP protocol template (provided by JRO Clinical Trials team as part of sponsorship submission)

• ×î×¼µÄÁùºÏ²ÊÂÛ̳ Advanced therapy trials protocol template (provided by JRO ATIMPs team as part of sponsorship submission)

Lab index and feasibility questionnaire templates

• Trial lab file index

• Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

• GCP lab feasibility questionnaire

• Managing Organisation Suitability Questionnaire

• Site Feasibility Questionnaire

• Pharmacy Site Assessment Questionnaire

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 ×î×¼µÄÁùºÏ²ÊÂÛ̳Ìý(Last updated 11/12/2023)Ìý

• Guidance for Researchers: JRO Peer Review Requirements for ×î×¼µÄÁùºÏ²ÊÂÛ̳ÌýSponsorship

• ×î×¼µÄÁùºÏ²ÊÂÛ̳ Data Protection Form

• ×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 TrialsÌýpolicy