SOP 11a

SOP 11a Sponsorship of MHRA regulated studies (Process for Researchers) [PDF 518KB]

• Associated document 1: Associated Document 1Costing MHRA regulated studies guidance [PDF 297KB]
• Associated document 2: JRMO Protocol Template for MHRA regulated studies [DOC 392KB]
• Associated document 3: Associated Document 3 JRMO document submission checklist [DOC 79KB]
• Patient Information Sheet and Consent Form Guidance [PDF 212KB]

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]