SOPs for UCL and UCLH sponsored CTIMPs

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

SOP for granting UCL sponsorship 

• UCL First Contact Questionnaire 

• CTIMP Protocol Template

SOP for the preparation and maintenance of the TMF and ISF

• JRO IMP Pharmacy Site File Review Checklist

• JRO IMP Pharmacy Site File Index

• JRO TMF Review Checklist

• JRO TMF Index

• JRO ISF Review Checklist

• JRO ISF Index

SOP for obtaining REC, CTA & HRA for CTIMPs

SOP for creating and maintaining an IB 

• UCL JRO IB Template

SOP for preparation for randomisation blinding and code breaks 

• Code Break Log Template

SOP on training

SOP for AE and SAE Reporting by Investigators

• SAE reporting form

• Pregnancy reporting form

SOP for the oversight and monitoring of UCL sponsored CTIMPs

SOP for Recording and Reporting of Deviations, Violations, Serious Breaches and Urgent Safety Measure 

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

SOP for the classification, review and submission of Amendments 

SOP on DSUR

• DSUR template

SOP for End of Trial Notification 

SOP for Archiving 

SOP for Electronic Signature 

Protocol templates for UCL/UCLH sponsored 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)

• UCL/UCLH Medical device trial protocol templates (CE marked, non-CE marked, in-house health exemption studies) – coming soon

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:

• • Consent forms and participant information

  • Contracts and study agreements

    • Model Clinical Trial Agreement (mCTA) and CRO-mCTA

    • Commercial Primary Care Model Clinical Trial Agreement (PC-mCTA)

    • model Clinical Investigation Agreement (mCIA) and CRO-mCIA

    • Model non-commercial agreement (mNCA)

    • Model agreements for Participant Identification Centres (mC-PICA and mNC-PICA)

    • Model Material Transfer Agreement

    • Standalone Data Processing Agreements

    • Other model agreements

• • Costing template - interactive costing tool (commercially sponsored studies)

  • CV

  • Statement of Activities and UK Schedule of Events/SoECAT

SOP for Peer Review for studies sponsored by UCL and UCLH (Last updated 11/12/2023) 

• Guidance for Researchers: JRO Peer Review Requirements for UCL/UCLH Sponsorship

• UCL Data Protection Form

• UCL Insurance Registration Form

• Risk Assessment (CTIMPs & non-CTIMPs)

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

UCL Complaints from Research Subjects About UCL Sponsored Studies and Trials policy