Clinical SAS: Clinical Data Management and Analysis with SAS

A warm welcome to the Clinical SAS: Mastering Clinical Data Management and Analysis with SAS course by Uplatz.

Clinical SAS is a software suite developed by SAS Institute, a leading provider of analytics and business intelligence solutions. SAS Clinical is specifically designed to support the needs of clinical research organizations and pharmaceutical companies in managing, analysing, and reporting clinical trial data.

Some key features of Clinical SAS include:

1. Data Management: SAS Clinical enables users to efficiently manage and integrate clinical trial data from multiple sources, including electronic health records, case report forms, laboratory data, and patient diaries.

2. Statistical Analysis: The software provides a comprehensive set of statistical tools for analysing clinical trial data, including descriptive statistics, hypothesis testing, regression analysis, survival analysis, and more.

3. Reporting and Visualization: SAS Clinical offers powerful reporting and visualization capabilities, allowing users to create customized reports, tables, graphs, and dashboards to communicate findings and insights effectively.

4. Regulatory Compliance: SAS Clinical is designed to meet regulatory requirements and standards such as FDA's 21 CFR Part 11, ensuring data integrity, security, and compliance with industry regulations.

5. Integration with Other Systems: SAS Clinical can be integrated with other systems and platforms commonly used in clinical research, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and data warehouses.

SAS Clinical provides a robust and flexible platform for managing and analysing clinical trial data, helping researchers and organizations streamline the drug development process, make informed decisions, and accelerate time to market for new therapies.

Clinical SAS - Course Curriculum

1. SAS Clinical Research Overview

2. Historical and Ethical background of Clinical Research and ICH-GCP Guidelines

3. Essential Documents in Clinical Research

4. Drug Development

5. Clinical Trial Process and Roles

6. Clinical Trial Design

7. Clinical Trial Monitoring

8. Glossary of Clinical Research Terms

9. Responsibilities of Sponsor

10. Site Selection and Responsibilities of Investigator and CRC

11. QA and QC Audit and Inspection

12. Non-Compliance, Fraud and Misconduct

13. 21 CFR part 11

14. Protocol Understanding

15. Clinical Data Management

16. Protocol Assignment

17. CRF Design and Format

18. CRF Design and Format demo

19. Clinical Data Standards

20. CDM Study Start Up

21. CDM - EDC Setup Concept

22. CDM - EDC Study Conduct Concept

23. CDM - EDC Study Conduct Discrepancy Management

24. CDM - Discrepancy Management

25. Data Management Plan

26. Project Management for Data Manager

27. Vendor Selection and Management

28. Edit Check Design Principles

29. EDC Study Closeout

30. CDM Study Closeout

31. CRF Completion Guidelines

32. Database Validation and Programming

33. Laboratory Data Handling

34. External Data Transfer

35. Patient Reported Outcome

36. Investigator Meeting

37. Metrics in CDM

38. Assuring Data Quality

39. Measuring Data Quality

40. Safety Data Management

41. Safety Data Reconciliation

42. Medical Coding

43. Clinical Data Archiving

44. Data Entry and Processing

45. Role and Responsibilities of CDM

46. Medical Device Trials

47. Clinical Research Q and A

48. Clinical Data Management Q and A

49. Clinical Research CDM Fundamental Q and A

50. Working with CROs and SOPs

51. CDISC - part 1

52. CDISC - part 2