SOP 38b - SOP 38b Electronic data management systems for MHRA-regulated studies [PDF 241KB]

• Associated document 1: SOP 38b AD 1 Requiements and specifications [DOC 110KB]
• Associated document 2: SOP 38b AD 2 CRF design guidance [PDF 57KB]
• Associated document 3: SOP 38b AD 3 Template Test Plan [DOC 100KB]
• Associated document 4: SOP 38b AD 4 Test Script Template [XLS 21KB]
• Associated document 5: SOP 38b AD 5 Database Change Control Log [DOC 44KB]
• Associated document 6: SOP 38b AD 6 Test Report Template [DOC 94KB]
• Associated document 7: SOP 38b AD 7 End of study activities [PDF 43KB]
• Associated document 8: SOP 38b AD 8 Data Management Systems Approval [DOC 83KB]