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

UCLH SOP 2 - Definition of Responsibilities (Version 3, effective date 21/12/2023)

• 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 (Last updated 11/12/203)

• Study Close Down Checklist for UCLH-Hosted Studies

SOP for Archiving of UCLH Investigator Site File and Pharmacy Site File

The investigator site file (ISF) for all non-UCL/UCLH sponsored studies (this includes commercial sponsored and externally sponsored non-commercial studies, where UCLH is a site) are to be archived with Iron Mountain. Staff are to request boxes, labels and arrange collection using their IM-Connect username and password.

If a department or user does not have access to Iron Mountain’s portal IM-Connect (www.ironmountainconnect.com) a request should be sent to uclh.medicalrecordsMH@nhs.net, with details of the department name, study budget code, the authorised user name with email address, address & telephone number  for where the deliveries and collections will be used which will then enable Medical Records to create an account.

View the SOP: Archiving of the UCLH Investigator Site File/Trial Master File

For more information, please contact the JRO: uclh.randd@nhs.net.

SOP for Iron Mountain.

• JRO Research Records Transfer Form (for UCL/UCLH sponsored studies only)

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

Researchers will need to complete the exemption application form.

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)

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