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SOPs for studies hosted at UCLH

SOPs and guidance relevant for research studies that are taking place at UCLH and are not managed by the JRO.

Note: some documents are accessible to UCLH staff only; clicking on these links may take you to the UCLH intranet, myUCLH

SOP for Definition of Responsibilities

SOP for Reporting Amendments

SOP for Reporting and Managing Incidents and Events in Research

SOP for Essential Documents and the Study File (TMF/ISF)

SOP for Study Close Down

SOP for Archiving of UCLH Investigator Site File and Pharmacy Site File (Please note: archiving services remain suspended at UCL until further notice)

SOP for Procedure for the review and approval of  Early-Phase 1/2a Clinical Trials or research studies with an Experimental Medicine Component at UCLH (in review; new version coming soon)

Research Monitor Access to UCLH EHRS (EpicCare Link UCLH) accessible to UCLH staff via intranet

On-site external research visits during COVID-19

UCLH Research Policies and Procedures

Consent to Participation in Research

Suspension of Recruitment to a Research Study Hosted at UCLH

Approval of Hosted Clinical Trials using Investigational Medicinal Products (IMPs) which are considered to be Genetically Modified Organisms

Risk Assessment process for clinical trials involving genetically modified organisms (GMO)

New Interventional Procedures - Introduction at UCLH Policy and Procedure

Scientific Fraud and Misconduct Policy