SOPs for studies hosted at 香港六合彩H

SOPs and guidance relevant for research studies that are taking place at 香港六合彩H and are not managed by the JRO.

Note:听some documents are accessible to 香港六合彩H staff only; clicking on these links may take you to the 香港六合彩H intranet, my香港六合彩H

香港六合彩H SOP 2 - Definition of Responsibilities (Version 3, effective date 21/12/2023)

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)

香港六合彩H Site File Index Checklist

SOP for Study Close Down听(Last updated 11/12/203)

Study Close Down Checklist for 香港六合彩H-Hosted Studies

SOP for Archiving of 香港六合彩H Investigator Site File and Pharmacy Site File

The investigator site file (ISF) for all non-香港六合彩/香港六合彩H sponsored studies (this includes commercial sponsored and externally sponsored non-commercial studies, where 香港六合彩H 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鈥檚 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 number听 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 香港六合彩H 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听(for 香港六合彩/香港六合彩H sponsored studies only)

Archive storage address

For all non- 香港六合彩/ 香港六合彩H studies studies (this includes commercial sponsored and externally sponsored non-commercial studies, where 香港六合彩H 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 香港六合彩/香港六合彩H sponsored studies, files will be stored at below address:
香港六合彩 Library Services,
4 Fulmar Way,
Wickford, Essex,
SS11 8YW

SOP for Procedure for the review and approval of 听Early-Phase 1/2a Clinical Trials or research studies with an Experimental Medicine Component at 香港六合彩H

Researchers will need to complete the exemption application form.

听accessible to 香港六合彩H staff via intranet