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

For Pharma, supports SDTM 3.1.1 and 3.1.2

For Medical Devices, supports SDTM-IG 3.2 and 3.3

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

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Common Pinnacle 21 Issues

1. Inconsistent value for AEDECOD within AETERM - Acceptable if AETERM contains to events and is split into individual events.  AEMODIFY is populated with the individual events so they are consistent with AETERM collected.

2. AESTDTC is after RFPENDTC - RFPENDTC should contain the last date that the patient was considered to still be participating in the study- so it could be an AE start/end date, visit date, or any other date indicating that data was still being collected for them.

3. AEACN value 'MULTIPLE' is not in non-extensible codelist (70%) - Should correct to report AEACN1 - 4 for each Action Taken with Study Treatment instead of one MULTIPLE response.  Other examples are RACE and DTYPE

RACE - Both subjects selected “Other, specify” on the CRF. Per the SDTM IG, DM.RACE=”OTHER”. Details of race can be found in SUPPDM.  

DTYPE set to “SUM” which is not a part of the DTYPE codelist in the 2017-03-31 ADaM terminology package. A value of “SUM” indicates that AVAL/AVALC was derived by adding values from prior observed records. 

4. Required variable not present (51%) - Could be false-positive messages

5. Variable label does not match standard (50%) - Should correct label.

6. INCONSISTENT VALUE FOR PARCAT WITHIN A UNIQUE PARAMCD (24%) - Correct PARAMCD to be 1:1 with PARCAT1 

7. Duplicate records exist - Correct data issue, Below are possible cases:

 Records with all variables having the exact same value (except --SEQ)

 Different results for the same laboratory test and collection time-point (e.g. one Normal and one Abnormal)

 Records with same Original Result, but different Original Units

 One record with actual result and another record on the same time-point as “NOT DONE”

 Records with same Results and Collection Dates/Times, but different Visits

 Records that are only different in LBSPID variable, which is not described in define.xml or SDRG 

8. Missing values in required variables - Ex. PRTRT, HOTERM, EXTRT variables are missing.

9. --STRF, --ENRF AND MISSING VALUE IN RFSTDTC, RFENDTC - maybe use --STRTPT and --STTPT

10. INCONSISTENT --STRESU - correct data to be 1:1 between LBTESTCD and LBSTRESU

11. Impute SDTM study day - do not impute in SDTM, impute in ADaMs

12. MISSING AE TREATMENT EMERGENT FLAG IN SUPPAE - Add variable

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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




 





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