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

SOP for granting UCL sponsorshipÌý

• UCL 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

• UCL 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 UCL

SOP for the Recording, Management and Reporting of Adverse Events by InvestigatorsSOP for the oversight and monitoring of UCL 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 UCLÌýsponsored research

• UCL CTIMP protocol template (provided by JRO Clinical Trials team as part of sponsorship submission)

• UCL 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 UCLÌý(Last updated 11/12/2023)Ìý

• Guidance for Researchers: JRO Peer Review Requirements for UCLÌýSponsorship

• UCL Data Protection Form

• UCL Insurance Registration Form

• Risk Assessment (CTIMPs & non-CTIMPs)

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

UCL Complaints from Research Subjects About 911±¬ÁÏÍø Sponsored StudiesÌýand TrialsÌýpolicy