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SOPs and guidance relevant for research studies that are taking place at Â鶹´«Ã½ÊÓƵÍøÕ¾H and are not managed by the JRO.

Note:Ìýsome documents are accessible to Â鶹´«Ã½ÊÓƵÍøÕ¾H staff only; clicking on these links may take you to the Â鶹´«Ã½ÊÓƵÍøÕ¾H intranet, myÂ鶹´«Ã½ÊÓƵÍøÕ¾H

Â鶹´«Ã½ÊÓƵÍøÕ¾H SOP 2 - Definition of Responsibilities (Version 3, effective date 21/12/2023)

• Â鶹´«Ã½ÊÓƵÍøÕ¾H study delegation log template
• Â鶹´«Ã½ÊÓƵÍøÕ¾H guide for approved responsibilities of site staff
• Â鶹´«Ã½ÊÓƵÍøÕ¾H 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 Â鶹´«Ã½ÊÓƵÍøÕ¾ File (TMF/ISF)

• Â鶹´«Ã½ÊÓƵÍøÕ¾H Site File Index Checklist

SOP for Â鶹´«Ã½ÊÓƵÍøÕ¾ Close DownÌý(Last updated 11/12/203)

• Â鶹´«Ã½ÊÓƵÍøÕ¾ Close Down Checklist for Â鶹´«Ã½ÊÓƵÍøÕ¾H-Hosted Studies

SOP for Archiving of Â鶹´«Ã½ÊÓƵÍøÕ¾H Investigator Site File and Pharmacy Site File

The investigator site file (ISF) for all non-Â鶹´«Ã½ÊÓƵÍøÕ¾/Â鶹´«Ã½ÊÓƵÍøÕ¾H sponsored studies (this includes commercial sponsored and externally sponsored non-commercial studies, where Â鶹´«Ã½ÊÓƵÍøÕ¾H 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 () 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 numberÌý 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 Â鶹´«Ã½ÊÓƵÍøÕ¾H 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 FormÌý(for Â鶹´«Ã½ÊÓƵÍøÕ¾/Â鶹´«Ã½ÊÓƵÍøÕ¾H sponsored studies only)

Archive storage address

For all non- Â鶹´«Ã½ÊÓƵÍøÕ¾/ Â鶹´«Ã½ÊÓƵÍøÕ¾H studies studies (this includes commercial sponsored and externally sponsored non-commercial studies, where Â鶹´«Ã½ÊÓƵÍøÕ¾H is a site), archiving will go to Iron Mountain: Iron Mountain Cody 4,
Unit 3C,
Cody Road Trading Estate,
Canning Town, London,
E16 4TG

For Â鶹´«Ã½ÊÓƵÍøÕ¾/Â鶹´«Ã½ÊÓƵÍøÕ¾H sponsored studies, files will be stored at below address:
Â鶹´«Ã½ÊÓƵÍøÕ¾ Library Services,
4 Fulmar Way,
Wickford, Essex,
SS11 8YW

SOP for Procedure for the review and approval of ÌýEarly-Phase 1/2a Clinical Trials or research studies with an Experimental Medicine Component at Â鶹´«Ã½ÊÓƵÍøÕ¾H

Researchers will need to complete the exemption application form.

Ìýaccessible to Â鶹´«Ã½ÊÓƵÍøÕ¾H staff via intranet

• Â鶹´«Ã½ÊÓƵÍøÕ¾H R&D Guidance Document for Sponsors & CROs on Accessing Â鶹´«Ã½ÊÓƵÍøÕ¾H EHRS (EpicCare Link)

Â鶹´«Ã½ÊÓƵÍøÕ¾H Research Policies and Procedures

Consent to Participation in Research

Suspension of Recruitment to a Research Â鶹´«Ã½ÊÓƵÍøÕ¾ Hosted at Â鶹´«Ã½ÊÓƵÍøÕ¾H

Use of Advanced Therapy Medicinal Products (ATMPs) and Genetically Modified Organisms (new ATIMP policy released 03.06.2024)

New Interventional Procedures - Introduction at Â鶹´«Ã½ÊÓƵÍøÕ¾H Policy and Procedure