Joint Research Office


SOPs and guides for Investigators

SOP for granting UCL sponsorship for Clinical Trials of Investigational Medicinal Products (CTIMPs)

SOP for Obtaining REC and CTA Approvals for CTIMPS

SOP for Preparation of Maintenance of TMF-ISF

SOP for Recording Management and Reporting of Adverse Events by Investigators

SOP for the Preparation of a Study, Randomisation, Binding and Code Break

SOP on Training Requirements for Staff Participating in CTIMPS

SOP for the Classification, Review and Submission of Clinical Trial Amendments

SOP for the Recording and Reporting (of Protocol and/or GCP) Deviations, Violations, Serious Breaches and Urgent Safety Measures

SOP for the Preparation and Submission of Development Safety Update Reports (DSUR)

 SOP for Creating and Maintaining an Investigators' Brochure for UCL Developed Products

SOP for Investigators for End of Trial Notification, Close Out and Trial Reporting Procedures

SOP for Archiving Essential Documents relating to CTIMPS

Additional Documents

SOP for Data Management Template Guide for Investigators

UCL Case Report Form Template

UCL Case Report Form Chief Investigator and Statistician Signature Page