Open CDISC / Pinnacle 21 (Tool) QC (See also Data Validation QC/QA Validation)

Supports SDTM 3.1.1 and 3.1.2

OpenCDISC SDTM Compliance Process Flow

A. Summary of issues image, do not pass OpenCDISC SDTM Compliance Report

B. Compliance (metadata, control term, data structure) or data issue image

C. QA checks failed image

D. Code to correct image, qa check passed, review/correct errors, warnings and notes based on guidelines

E. Correct SDTM dataset image, follow guidelines and pass OpenCDISC SDTM Compliance Report

1. Interpreting ADaM standards with OpenCDISC, Trupti Bal, Madhura Paranjape (Basetype)

2. Running OpenCDISC in SAS, Kevin Lee [HOW]

3. OpenCDISC: Beyond Point and Click, Frank DiIorio

4. Resolving OpenCDISC Error Messages Using SAS®, Virginia Redner and John Gerlach [Macros] 

5. Let SAS© Improve Your CDISC Data Quality, Wayne Zhong [Edit Checks]

6. CDISC SDTM Conformance and OpenCDISC, Micaela Salgado-Gomez [Presentation]

7. Adopted Changes for SDTMIG v3.1.3 and 2013 OpenCDISC Upgrades, Yi Liu, Stephen Read

8. A Standard SAS® Program for Corroborating OpenCDISC Error Messages, John Gerlach [Macros]

9. Let SAS handle your CDISC compliance check: automating OpenCDISC Validator in SAS, Edwin van Stein

10. Thanks CDISC – Free Utilities, Robert Agostinelli [OpenCDISC]

11. OpenCDISC Plus, Annie Guo

12. Improving Data Quality - Missing Data Can Be Your Friend!, Julie Che

13. Reading and Resolving OpenCDISC Messages, Penny Pang [Presentation]

14. Most Common Issues in ADaM Data, Sergiy Sirichenko and Michael DiGiantomasso [Presentation]

15. Usage of OpenCDISC Community Toolset 2.0 for Clinical Programmers, Sergiy Sirichenko, Michael DiGiantomasso, Travis Collopy [HOW]

16.  A Preventive Approach for Automatic Checking of CDISC ADaM Metadata to Detect Noncompliance

17. SAS and Open Source Tools for CDISC SDTM Compliance Checks for Regulatory Submissions, Peter Loonan, Sandeep Kottam, Sree K Tripuraneni

18. OpenCDISC Validator Implementation: A Complex Multiple Stakeholder Process, Terek Peterson, Gareth Adams

19. Validation Checks Performed by WebSDM Version 2.6 on SDTM version 3.1.1 Datasets

20. Common Programming Errors in CDISC Data, Sergiy Sirichenko

21. The Most Common Issues in Submission Data, Sergiy Sirichenko, Max Kanevsky

22. Pinnacle 21 Enterprise [Presentation]

23. De-Identification of Clinical Trials Data Demystified Jack Shostak

24. Usage of Pinnacle 21 Community Toolset 2.2.0 for Clinical Programmers, Sergiy Sirichenko and Michael DiGiantomasso [How-to]

25. Usage of Pinnacle 21 Community Toolset 2.1.1 for Clinical Programmers, Sergiy Sirichenko, Michael DiGiantomasso, Travis Collopy

26. Good Data Validation Practice, Sergiy Sirichenko, Max Kanevsky

27. Doctor's ‘Prescription’ to Re-engineer Process of Pinnacle 21 Community Version Friendly ADaM Development, Aakar Shah

28. Duplicate records - it may be a good time to contact your data management team Sergiy Sirichenko, Max Kanevsky

29. Seven Habits of Highly Effective Issue Managers, Amy Garrett

30. Common Pinnacle 21 Report Issues: Shall we Document or Fix?, Ajay Gupta

31. Achieving Zen: A Journey to ADaM Compliance, Kirsty Lauderdale, Kjersten Offenbecker, Alice Ehmann [QC checklist]

32. Exploring Common CDISC ADaM Conformance Findings, Trevor Mankus

33. Confusing Data Validation Rules Explained Michael Beers

34. The Truth About False Positives, Kristin Kelly, Michael Beers

35. Pinnacle 21 Community v3.0 - A Users Perspective, Ajay Gupta

36. How to Automate Validation with Pinnacle 21 Command Line Interface and SAS, Amy Garrett and Aleksey Vinokurov [Presentation]

37. Incorporating Pinnacle21 With LSAF, Sonali Garg, Sandeep Juneja, Aleksey Vinokurov [Presentation]

38. Usage of Pinnacle 21 Community Toolset 2.1.1 for Clinical Programmers, Sergiy Sirichenko, Michael DiGiantomasso, Travis Collopy

39. De-Identification of Data & Its Techniques, Shabbir Bookseller