Practical Guide to Clinical Data Management
eBook - PDF

Practical Guide to Clinical Data Management

  1. 296 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Practical Guide to Clinical Data Management

About this book

Clinical data management (CDM) has gone from predominantly relying on the collection of data on paper forms to using electronic data capture (EDC). Today, the assumption is that a trial will be conducted using EDC and that extenuating circumstances might lead to it being conducted using paper. This third edition emphasizes the EDC process. The chapters in the text are organized to represent the main elements of CDM: study startup, study conduct, and study closeout. In addition, a new chapter on the clinical trial process explains the high level flow of a clinical trial from creation of the protocol through the study lock and provides the context for the clinical data management activities that follow.

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Yes, you can access Practical Guide to Clinical Data Management by Susanne Prokscha in PDF and/or ePUB format, as well as other popular books in Computer Science & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2011
Print ISBN
9781498767446
eBook ISBN
9781439848319
Edition
3
Topic
Computer Science
Subtopic
Pharmacology
Index
Computer Science

Table of contents

  1. Front Cover
  2. Contents
  3. Preface
  4. Introduction
  5. Chapter 1: The Data Management Plan
  6. Chapter 2: CRF Design Considerations
  7. Chapter 3: Database Design Considerations
  8. Chapter 4: Edit Checks
  9. Chapter 5: Preparing to Receive Data
  10. Chapter 6: Receiving Data on Paper
  11. Chapter 7: Overseeing Data Collection
  12. Chapter 8: Cleaning Data
  13. Chapter 9: Managing Lab Data
  14. Chapter 10: Non-CRF Data
  15. Chapter 11: Collecting Adverse Event Data
  16. Chapter 12: Creating Reports and Transferring Data
  17. Chapter 13: Study Database Lock
  18. Chapter 14: After Database Lock
  19. Chapter 15: Standard Operating Procedures (SOPs)
  20. Chapter 16: Training
  21. Chapter 17: Controlling Access and Security
  22. Chapter 18: Working with CROs
  23. Chapter 19: Clinical Data Management Systems
  24. Chapter 20: EDC Systems
  25. Chapter 21: Choosing Vendor Products
  26. Chapter 22: Implementing New Systems
  27. Chapter 23: System Validation
  28. Chapter 24: Test Procedures
  29. Chapter 25: Change Control
  30. Chapter 26: Coding Dictionaries and Systems
  31. Chapter 27: Migrating and Archiving Data
  32. Appendix A: Data Management Plan Outline
  33. Appendix B: Clinical Data Management SOPs
  34. Appendix C: CRO-Sponsor Responsibility Matrix
  35. Appendix D: Implementation Plan Outline
  36. Appendix E: Validation Plan Outline
  37. Appendix F: CDISC and HIPAA
  38. Bibliography
  39. Back Cover