Part I. Preliminaries

Table of Contents

1. Introduction
1.1. Objective
1.2. Approach
1.3. The Kit
1.4. Instructions
1.5. Notes
2. ATK Worksheet
2.1. Using the Worksheet
2.2. Module 1: Installation and Initialization
2.3. Module 2: DFexplore Client Applications
2.4. Module 3: Study Setup
2.5. Module 4: EDC Data Entry
2.6. Module 5: Fax Data Entry
2.7. Module 6: User-Defined Query Category Types
2.8. Module 7: Multiple Queries Per Field
2.9. Module 8: Double Data Entry (DDE)
2.10. Module 9: Data Review
2.11. Module 10: External Query Reports
2.12. Module 11: Replying to EDC Queries, eSignatures
2.13. Module 12: Refaxing CRFs and Correcting Queries
2.14. Module 13: Data Export and DFsas
2.15. Module 14: PDF File Creation
2.16. Module 15: eCRF Creation for DFdiscover
2.17. Module 16: DFweb Data Entry
2.18. Module 17: DFcollect Mobile Data Collection
2.19. Signature and Date
3. Discrepancy Report
3.1. Problem
3.2. Immediate Workaround
3.3. Problem Resolution
3.4. Signature and Date