SOPs for management, in-progress, and close down of sponsored clinical trials of medicinal products

SOP for Preparation of Maintenance of TMF-ISF

SOP for Recording Management and Reporting of Adverse Events by Investigators

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

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 Oversight and Monitoring of UCL CTIMPs

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

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

SOP for Archiving Essential Documents relating to CTIMPS