SOPs and guidance relevant for research studies that are taking place at ×î×¼µÄÁùºÏ²ÊÂÛ̳H and are not managed by the JRO.
Note:Ìýsome documents are accessible to ×î×¼µÄÁùºÏ²ÊÂÛ̳H staff only; clicking on these links may take you to the ×î×¼µÄÁùºÏ²ÊÂÛ̳H intranet, my×î×¼µÄÁùºÏ²ÊÂÛ̳H
×î×¼µÄÁùºÏ²ÊÂÛ̳H SOP 2 - Definition of Responsibilities (Version 3, effective date 21/12/2023)
- ×î×¼µÄÁùºÏ²ÊÂÛ̳H study delegation log template
- ×î×¼µÄÁùºÏ²ÊÂÛ̳H guide for approved responsibilities of site staff
- ×î×¼µÄÁùºÏ²ÊÂÛ̳H Principal Investigator Responsibilities template
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 DownÌý(Last updated 11/12/203)
SOP for Archiving of ×î×¼µÄÁùºÏ²ÊÂÛ̳H Investigator Site File and Pharmacy Site File
The investigator site file (ISF) for all non-×î×¼µÄÁùºÏ²ÊÂÛ̳/×î×¼µÄÁùºÏ²ÊÂÛ̳H sponsored studies (this includes commercial sponsored and externally sponsored non-commercial studies, where ×î×¼µÄÁùºÏ²ÊÂÛ̳H 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 ×î×¼µÄÁùºÏ²ÊÂÛ̳H 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 ×î×¼µÄÁùºÏ²ÊÂÛ̳/×î×¼µÄÁùºÏ²ÊÂÛ̳H sponsored studies only)
Archive storage address
For all non- ×î×¼µÄÁùºÏ²ÊÂÛ̳/ ×î×¼µÄÁùºÏ²ÊÂÛ̳H studies studies (this includes commercial sponsored and externally sponsored non-commercial studies, where ×î×¼µÄÁùºÏ²ÊÂÛ̳H 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 ×î×¼µÄÁùºÏ²ÊÂÛ̳/×î×¼µÄÁùºÏ²ÊÂÛ̳H sponsored studies, files will be stored at below address:
×î×¼µÄÁùºÏ²ÊÂÛ̳ Library Services,
4 Fulmar Way,
Wickford, Essex,
SS11 8YW
Researchers will need to complete the exemption application form.
Ìýaccessible to ×î×¼µÄÁùºÏ²ÊÂÛ̳H staff via intranet
×î×¼µÄÁùºÏ²ÊÂÛ̳H Research Policies and Procedures
Consent to Participation in Research
Suspension of Recruitment to a Research Study Hosted at ×î×¼µÄÁùºÏ²ÊÂÛ̳H
New Interventional Procedures - Introduction at ×î×¼µÄÁùºÏ²ÊÂÛ̳H Policy and Procedure