SOP 11b

SOP 11b Sponsorship MHRA regulated studies (Process for the JRMO) [PDF 509KB]

• Associated Document 1:   Guidance for GCP and Governance section staff [DOC 92KB]
• Associated Document 2:   Sponsor confirmation of sponsorship email template (Not a public document)
• Associated Document 3:   Final governance meeting report [DOC 82KB]
• Associated Document 4a: Sponsor CI agreement (Barts_Health) [DOC 65KB]
• Associated Document 4b: Sponsor CI agreement (Queen Mary) [DOC 69KB]
• Associated Document 5:   Sponsor confirmation of sponsorship email template (Not a public document)

Following the implementation of ICH E6 (R3), guidance was finalised in relation to the improvement/requirements of quality, quality by design and risk-based quality within clinical trials and the connection with the requirements of ICH E8 (R1)

Clinical trials for medicines_ guidance on quality and risk proportionality - GOV.UK [PDF 245KB]