SOP 38b - SOP 38b Electronic data management systems for MHRA-regulated studies [PDF 259KB]

• Associated document 1: SOP 38b AD 1 Requiements and specifications [DOC 205KB]
• Associated document 2: SOP 38b AD 2 CRF design guidance [PDF 146KB]
• Associated document 3: SOP 38b AD 3 Template Test Plan [DOC 167KB]
• Associated document 4: SOP 38b AD 4 Test Script Template [XLS 20KB]
• Associated document 5: SOP 38b AD 5 Database Change Control Log [DOC 73KB]
• Associated document 6: SOP 38b AD 6 Test Report Template [DOC 144KB]
• Associated document 7: SOP 38b AD 7 End of study activities [PDF 56KB]
• Associated document 8: SOP 38b AD 8 Data Management Systems Approval [DOC 82KB]