Taking Ownership of Custom Database Roles in Oracle Clinical and RDC
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Transcript of Taking Ownership of Custom Database Roles in Oracle Clinical and RDC
Taking Ownership of Custom Database Roles in OC/RDC
Tammy Dutkin, Director of Clinical Data Management & EDC, Life Sciences
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Perficient is a leading information technology consulting firm serving clients throughout
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We help clients implement business-driven technology solutions that integrate business
processes, improve worker productivity, increase customer loyalty and create a more agile
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About Perficient
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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
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
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
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
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
Grants for New Role …
• Add new role to the OPA_MENU_ROLES codelist … then …
Grants for New Role
– The new role (DEB) will then appear in the Menu Roles matrix report
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
Reference Codelists …
• Update reference codelists
– User Groups
Reference Codelists …
– User Group Roles
Reference Codelists …
– Discrepancy Rev Status Code
• If any additional options are needed for the new role(s)
Reference Codelists …
• Create new reference codelists (via DTK) … if new role user will be
doing discrepancy management via RDC
– Discrepancy Actions <new role>
Reference Codelists …
– Discrepancy Status <new role>
Reference Codelists
• Update other Discrepancy Actions <role> and Discrepancy Status
<role> codelists as applicable
OC Discrepancy Management …
• Update DM User Group Admin … if new role user will be doing
discrepancy management via OC
OC Discrepancy Management
• Create DM Profile (optional)… if new role user will be doing OC DM
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
…
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
RDC Study / Site Access
• Set Study and/or Study Site Access (at User level – new user with
new custom role = TESTBRWS)
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)
In RDC …
• Open a PE eCRF
PE form in Browse mode (see watermark)
In RDC …
• Open Demo eCRF
Demo form in Update
Discrepancy mode – can update/route
discrepancies on Demo form
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
11/13/2014 28
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