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- Study Closeout
- Database Lock
- Reconciliation of Electronic Lab Data
- Serious Adverse Event Reconciliation
- Study Close Audit (typically handled by the QA/QC department)
- Audit of Data Extraction and Output
- Generation and Review of Archive Media
- Maintenance of Coding Dictionaries
- Vendor Audits/Management
Original Documentation: View file name 10-EDC Study Closeout Oct 2013.pdf height 250Click here