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Taking Ownership of Custom Database Roles in Oracle Clinical and RDC


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One of the fundamental requirements of 21 CFR Part 11 is controlling user access in clinical trial applications. You do not want to unintentionally give someone access to something he or she should not have. To avoid these situations, Oracle Clinical and Remote Data Capture (RDC) comes with a set of predefined database roles that system administrators can set to enable users to perform specific tasks, yet prevent them from taking actions they are not authorized to take.

While the predefined roles serve as a good starting point, it is critical for organizations to decide which roles make sense for the way they do business. In such cases, it may be beneficial to create new custom roles. While this process is not overly complex, it is easy to overlook several aspects that can make all the difference.

Perficient’s Tammy Dutkin, director of Clinical Data Management and EDC, showed organizations how to take ownership of their own database roles to ensure they remain compliant.

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Taking Ownership of Custom Database Roles in Oracle Clinical and RDC

  1. 1. Taking Ownership of Custom Database Roles in OC/RDC Tammy Dutkin, Director of Clinical Data Management & EDC, Life Sciences
  2. 2. About Perficient 2 Perficient is a leading information technology consulting firm serving clients throughout North America. We help clients implement business-driven technology solutions that integrate business processes, improve worker productivity, increase customer loyalty and create a more agile enterprise to better respond to new business opportunities.
  3. 3. Perficient Profile 3 • Founded in 1997 • Public, NASDAQ: PRFT • 2013 revenue $373 million • Major market locations: • Allentown, Atlanta, Boston, Charlotte, Chicago, Cincinnati, Columbus, Dallas, Denver, Detroit, Fairfax, Houston, Indianapolis, Minneapolis, New York City, Northern California, Oxford (UK), Philadelphia, Southern California, St. Louis, Toronto, Washington, D.C. • Global delivery centers in China and India • >2,200 colleagues • Dedicated solution practices • ~90% repeat business rate • Alliance partnerships with major technology vendors • Multiple vendor/industry technology and growth awards
  4. 4. Business Process Management Customer Relationship Management Enterprise Performance Management Enterprise Information Solutions Enterprise Resource Planning Experience Design Portal / Collaboration Content Management Information Management Mobile BUSINESS SOLUTIONS 50+ PARTNERS Safety / PV Clinical Data Management Electronic Data Capture Medical Coding Clinical Data Warehousing Clinical Data Analytics Clinical Trial Management Healthcare Data Warehousing Healthcare Analytics CLINICAL / HEALTHCARE IT Consulting Implementation Integration Migration Upgrade Managed Services Private Cloud Hosting Validation Study Setup Project Management Application Development Software Licensing Application Support Staff Augmentation Training SERVICES
  5. 5. Introduction Tammy Dutkin Director of Clinical Data Management & EDC Life Sciences, Perficient • Background – 20+ years of clinical research and data management experience – Previously SVP at DSP Clinical Research and VP at Advanced Clinical
  6. 6. Agenda • Topics to Cover – Why create custom roles – Creating a custom role – Granting the necessary access and privileges to a new role – Granting the new role to the appropriate user accounts – Updating reference codelists, and other administrative settings and accesses, etc – Testing
  7. 7. Why? • Why create custom roles – May be necessary if the default roles provided do not fit or cannot be modified to fit your business processes • This could be for OC tasks/roles, but is probably more commonly needed for RDC users • Usually to further limit what RDC users can see and/or do
  8. 8. Creating Role • Creating a Custom Database Role – Log on to SQL*Plus as SYSTEM user – Create the custom role (prefix with RXC for OC/RDC role) • e.g., RXC_BRWS • SQL> create role RXC_BRWS; – Explicitly grant all database privileges required for the users with this role to do the tasks intended
  9. 9. Grants for New Role … • Grant the new role access to menu items (via DTK) – In OC, RXC_BRWS will have access to only DE Browse
  10. 10. Grants for New Role … • Add new role to the OPA_MENU_ROLES codelist … then …
  11. 11. Grants for New Role – The new role (DEB) will then appear in the Menu Roles matrix report
  12. 12. Create New User for New Role • Create new user account to use the new role – Via SQL*Plus as SYSTEM – Username: TESTBRWS • no ops$ prefix needed if v.5.0+ • no ops$ prefix needed if RDC-only user – Grant roles to the new user, e.g.: • CONNECT • RESOURCE • OCL_ACCESS • RXCLIN_READ • RXCLIN_MOD • RXCLIN_SEC • RXC_ANY • RXC_BRWS • RDC_ACCESS • RXC_RDC • RXC_RDCT
  13. 13. Reference Codelists … • Update reference codelists – User Groups
  14. 14. Reference Codelists … – User Group Roles
  15. 15. Reference Codelists … – Discrepancy Rev Status Code • If any additional options are needed for the new role(s)
  16. 16. Reference Codelists … • Create new reference codelists (via DTK) … if new role user will be doing discrepancy management via RDC – Discrepancy Actions <new role>
  17. 17. Reference Codelists … – Discrepancy Status <new role>
  18. 18. Reference Codelists • Update other Discrepancy Actions <role> and Discrepancy Status <role> codelists as applicable
  19. 19. OC Discrepancy Management … • Update DM User Group Admin … if new role user will be doing discrepancy management via OC
  20. 20. OC Discrepancy Management • Create DM Profile (optional)… if new role user will be doing OC DM
  21. 21. RDC DCI Access … • For RDC, add the new role to ‘Default DCI Access by Role’ window – Restricted or Unrestricted – Can then be overwritten at the study level DCIs …
  22. 22. RDC DCI Access • … set study-specific DCI Access (if applicable) Note: – No access to TRTMNT DCI – Browse only for PE, EXC, PREG – User’s privileges on other DCIs
  23. 23. RDC Study / Site Access • Set Study and/or Study Site Access (at User level – new user with new custom role = TESTBRWS)
  24. 24. In RDC … • Log on to RDC as TESTBRWS user: – Access to only one study Notice: No access to TRTMNT eCRF (page #7 in Baseline visit)
  25. 25. In RDC … • Open a PE eCRF PE form in Browse mode (see watermark)
  26. 26. In RDC … • Open Demo eCRF Demo form in Update Discrepancy mode – can update/route discrepancies on Demo form
  27. 27. Testing • TEST!! … TEST!! … TEST!! – THOROUGHLY test the results of your customizations against your original requirements – DOCUMENT … DOCUMENT … DOCUMENT! – Should have SOPs and/or WINs in place for such customizations
  28. 28. 11/13/2014 28
  29. 29. Thank You! For more information, please contact: (Sales) +44 (0) 1865 910200 (U.K. Sales) +1 919 462 6395 (U.S. Sales)