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.

1. Taking Ownership of Custom Database Roles in OC/RDC
Tammy Dutkin, Director of Clinical Data Management & EDC, Life Sciences
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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. Perficient Profile
3
• Founded in 1997
• Public, NASDAQ: PRFT
• 2013 revenue $373 million
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5. Introduction
Tammy Dutkin
Director of Clinical Data Management & EDC
Life Sciences, Perficient
Tammy.Dutkin@perficient.com
• Background
– 20+ years of clinical research and data management
experience
– Previously SVP at DSP Clinical Research and VP at
Advanced Clinical

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. 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. 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. 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. Grants for New Role …
• Add new role to the OPA_MENU_ROLES codelist … then …

11. Grants for New Role
– The new role (DEB) will then appear in the Menu Roles matrix report

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. Reference Codelists …
• Update reference codelists
– User Groups

14. Reference Codelists …
– User Group Roles

15. Reference Codelists …
– Discrepancy Rev Status Code
• If any additional options are needed for the new role(s)

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. Reference Codelists …
– Discrepancy Status <new role>

18. Reference Codelists
• Update other Discrepancy Actions <role> and Discrepancy Status
<role> codelists as applicable

19. OC Discrepancy Management …
• Update DM User Group Admin … if new role user will be doing
discrepancy management via OC

20. OC Discrepancy Management
• Create DM Profile (optional)… if new role user will be doing OC DM

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. 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. RDC Study / Site Access
• Set Study and/or Study Site Access (at User level – new user with
new custom role = TESTBRWS)

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. In RDC …
• Open a PE eCRF
PE form in Browse mode
(see watermark)

26. In RDC …
• Open Demo eCRF
Demo form in
Update
Discrepancy mode
– can update/route
discrepancies on
Demo form

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. 11/13/2014 28

29. Thank You!
For more information, please contact:
Tammy.Dutkin@perficient.com
LifeSciencesInfo@perficient.com (Sales)
+44 (0) 1865 910200 (U.K. Sales)
+1 919 462 6395 (U.S. Sales)
www.perficient.com
www.facebook.com/perficient
www.twitter.com/perficient_LS