Resources for clinical research governance

University sponsor SOPs, safety reporting documents, and protocol and report templates

NOTICE: Webpage being updated

Update December 2024: In line with the iPassport (RGEA) QMS Change Implementation Plan this RGEA webpage is in the process of being updated.

As part of the change to the RGEA QMS, the University of Oxford “core SOPs” have been recategorized as University “sponsor SOPs”. The indexing of the SOPs (i.e. the numbering system employed for them) has been maintained. The documents have been up-versioned onto a new template with a new footer reflecting the new category and index, and cross references to other documents have been updated but there has otherwise been no change to the content of the SOPs.

  • The items listed below as “CORE SOP 002” and “CORE SOP 007” have been recategorized as Sponsor Guidance Documents and will be relocated to another section of the webpages in 2025.
  • A detailed note of all changes will be made available here for download when the implementation has been completed.
  • UoO CTUs do not need to confirm compliance with the up-versioned SOPs.

University sponsor SOPs should be used for all clinical trials sponsored by the University, and clinical research where appropriate.

If you require more detail than appears in a relevant University sponsor SOP, unit SOPs or work instructions may be developed, provided they are compliant with University sponsor SOPs. An editable version of the sponsor SOP is available on request by emailing RGEA.SOP@admin.ox.ac.uk.

Other templates can be adapted for use in any department conducting clinical research where there are no such templates in place. Content should be reviewed in conjunction with guidelines/procedures that are unique to each department and the text altered accordingly.

Text highlighted in yellow within documents is advisory and should be deleted when documents are finalised. If there is a footnote with details of the original author and the copyright logo of the University of Oxford, please retain them.

Please refer to this page for the latest approved version of each document and for new sponsor SOPs.

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Subscribe to the RGEA SOPs mailing list to receive updates and information related to the University sponsor SOPs. Please send an email to: rgeacoresop-subscribe@maillist.ox.ac.uk from the email address you wish to subscribe from. This is an automated email, so you will not need to include a message or subject. You will receive an automated email back asking you to confirm your subscription. Simply reply to that automated subscription email (message can be blank) to complete your subscription.

You can unsubscribe from the RGEA SOPs mailing list at any time. Simply send an email (using the email address you subscribed with) to rgeacoresop-unsubscribe@maillist.ox.ac.uk or by clicking the unsubscribe link at the bottom of one of our mailing list emails.

Please note: This mailing list is for Oxford University staff only (although members of Oxford's JRO are also welcome to subscribe). Please provide your work email address to subscribe to the list. Subscription to this list is moderated and RGEA reserves the right to reject subscription requests. Registration to this mailing list is a requirement for Oxford CTU colleagues with Quality Assurance responsibilities (e.g QA Managers, CTU Operations Leads) and all of RGEA. 

Contacts

RGEA TEAM  

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