SOP 38b
SOP 38b - Trial data management systems [PDF 656KB]
- Associated document 1: CRF design guidance [DOC 75KB]
- Associated document 2: good documentation practice [DOC 26KB]
- Associated document 3: user acceptance testing [DOC 20KB]
- Templates 1: data management plan [DOC 28KB]
- Template 2: Database change control form [DOC 36KB]
- Template 3: Sign-off form [DOC 14KB]
- Template 4: requirements and specifications [DOC 203KB]
