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

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.

About Perficient

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• Founded in 1997

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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

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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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)