Module 5 Presentations

eSystem Vendors and Data Integrity

• Audit trails incomplete, not available as data sets, sponsor not retaining all metadata and no review. • Contract deficiencies between eVendor and sponsor relating to GCP compliance, deviations/serious breach notification, Essential Documents and Data Retention. • eVendors do not realise that they have essential documents. • eVendors have no due diligence processes (relating to regulatory/REC approvals). • Documentation issues within CSV (no reference to protocol, inability to reconstruct process as decision/rationale not documented).

35

35

Other Useful Information

36

36

18