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

• UCLH study delegation log template
• UCLH guide for approved responsibilities of site staff
• UCLH Principal Investigator Responsibilities template

SOP for Reporting Amendments

SOP for Reporting and Managing Incidents and Events in Research

• Reference safety information (RSI) hints and tips sheet

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

• UCLH Site File Index Checklist

SOP for Study Close Down

• Study Close Down Checklist for UCLH-Hosted Studies

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

• JRO Research Records Transfer Form

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

• UCLH R&D Guidance Document for Sponsors & CROs on Accessing UCLH EHRS (EpicCare Link)

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)

• UCLH GM Clinical Use Risk Assessment Form

New Interventional Procedures - Introduction at UCLH Policy and Procedure

Scientific Fraud and Misconduct Policy