SOPs and guides for Investigators

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

• Pharmacy Site Assessment Questionnaire
• UCL First Contact Questionnaire
• UCL Site Feasibility Questionnaire
• SOPs and Process Overview
• Overview of Sponsorship Pathway
• Peer Review Requirements to secure UCL/UCLH Sponsorship
• UCL Protocol Template 
• UCL Patient Information Sheet (PIS) Template
• UCL Informed Consent Form (ICF) Template 

SOP for Obtaining REC and CTA Approvals for CTIMPS

SOP for Preparation of Maintenance of TMF-ISF

• CI Trial Master File Index
• Investigator Site File Index

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

• Code Break Log Template
• 24 Hour Contract Card Template
• Randomisation SOP Template

SOP on Training Requirements for Staff Participating in CTIMPS

• Individual Staff SOP and Course Log

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

• Log Associated with 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

• CI/PI Log 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)

• UCL DSUR Template

 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