SOPs for set up and sponsorship of Clinical Trials of Medicinal Products (CTIMPs)

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

• UCL First Contact Questionnaire
• UCL Protocol Template - CTIMPS
• UCL Protocol Template - Devices
• UCL Investigators Brochure

SOP for Obtaining REC and CTA Approvals for CTIMPS

SOP for Recording Management and Reporting of Adverse Events by Investigators

• AE Recording and Reporting Log
• SAE Reporting Form
• Pregnancy Form

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

SOP on Training Requirements for Staff Participating in CTIMPS

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

Lab Index and feasibility questionnaire templates

• Trial lab file index
• Reflection paper for laboratories that perform the analysis or evaluation of clinical trial sample
• GCP lab feasibility questionnaire