This document provides a 3 sentence summary of the key points from the document: The document outlines new features in Oracle Clinical 4.6 including enhanced page access controls, conditional branching in online data entry, flexible study design features like data-triggered rules and interval rules, and copying pages between case report forms. It describes how these features are configured and how they impact the user experience in online data entry. Examples are provided to illustrate how the new functionality works.

1. Study Setup
with the New
4.6
4 6 Features
Lori Tholkes Venable
15th Annual OHSUG Conference, Oct 2010 – San Antonio

2. Introduction
• OC/RDC v.4.6 is an incremental release
providing major enhancements to RDC V4 5 3
V4.5.3
• Functionality added to OC to support new
features in RDC
• Some older Oracle Clinical functionality has
also been enhanced for ease of use
• Many of the new features will not be covered
in this presentation due to time constraints
p
– Opted to present the most requested features
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3. Topics
• Page (DCI) Access (Admin / Definition)
• C diti
Conditional Bl Branching / C diti
hi Conditional l
Blocks (Definition)
• Flexible Study Design (Definition)
– Enhanced DCI Books
• DCI Expectedness Rules
• Interval Expectedness Rules
• Copying
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4. Page (DCI) Access …
• Pre-4.6 user access could be controlled by:
– Study level security
– Study Site level security
• V 4 6 also allows access at DCI (form) level
V.4.6
– At User Role level
• Default user role settings at installation level
– Either completely RESTRICTED or UNRESTRICTED
– Can override at study level for any user role
Note: if you create new user roles, you must define the
default DCI access for every role you plan to use or
that role will not be able to log in to RDC Onsite
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5. DCI Access …
• Installation level: for each user role, define
access as either:
– UNRESTRICTED – all DCIs visible to the user
– RESTRICTED – no DCI visible to the user
– for each role, OC sets default to UNRESTRICTED
• Study level: specify the exceptions:
– for User Roles with UNRESTRICTED access, you
EXCLUDE certain DCIs from their access
– for User Roles with RESTRICTED access, you
INCLUDE certain DCIs they can access
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6. DCI Access … Installation level
Admin Users and Roles Default DCI Access by Role
Default – all roles are
UNRESTRICTED
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7. DCI Access … Installation level
Admin Users and Roles Default DCI Access by Role
Edited – at the installation level –
across all studies, unless study
, y
level specificity defined
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8. DCI Access …Study level
Definition DCIs DCI Access (upper block)
BIOSTAT role RESTRICTED
at Installation level
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9. DCI Access …Study level
Definition DCIs DCI Access (lower block)
BIOSTAT role has this Access to
only these DCIs at Study level;
NO Access to TRTMNT DCI
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10. DCI Access …Study level
Definition DCIs DCI Access (CRA user role)
CRA role UNRESTRICTED at
Installation level
CRA role h li it d A
l has limited Access
to these DCIs at Study level;
full access to all other DCIs
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11. DCI Access …Study level …
What CRA will see in RDC Onsite – DEMO DCI:
CRA role has BROWSE only
access to DEMO DCI
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12. DCI Access …Study level …
What CRA will see in RDC Onsite – TRTMNT DCI:
CRA role has NO access to
TRTMNT DCI (collected at
Baseline Visit)
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13. DCI Access …Study level
What others see in RDC Onsite – TRTMNT DCI:
DM role has access to
TRTMNT DCI
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14. Conditional Branching in Onsite …
• Conditional Branching previously available
only in Character DE (OC & RDC Classic)
– Not available in Onsite (except Indicator
Question functionality) until v.4.6
• Setup in OC: DCM Question definition and
DCM Graphic Layout
– DCM Question definition uses same screens used
by character mode conditional branching
• Options of “hiding” or “greying out” the
hiding greying out
disabled questions
– Admin level setting can be overridden for study
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15. Conditional Branching in Onsite …
Admin DCI Form Local Database Settings (system level)
Can be overridden at
the study level
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16. Conditional Branching in Onsite …
• Conditional Branch defined at DCM Question
– DEMO … GENDER
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17. Conditional Branching in Onsite …
then…
then
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18. Conditional Branching in Onsite …
Upon clicking [OK] – before editing – need to edit
the blocks
Source Question = magenta
S Q ti t
Target Question = green
g g
Conditional Block of
Questions = orange
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19. Conditional Branching in Onsite …
Edited – moved ‘Begin Block’ and ‘End Block’ lines
Moved ‘End Block’ to include
PREGDT in PREG_YN block
i PREG YN bl k
Moved ‘End Block’ to include
OTHTX in RACE block
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20. Conditional Branching in Onsite …
What you see in Onsite DE -
‘Represent Disabled Blocks as’
Represent as
set as GREYED
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21. Conditional Branching in Onsite …
During
D i DE - G d = MALE
Gender MALE;
Pregnancy block remains GREYED
and cursor moves to RACE
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22. Conditional Branching in Onsite
During DE - Gender = FEMALE;
Pregnancy block UN GREYs and
UN-GREYs
cursor moves to PREG_YN
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23. Enhanced DCI Books…
• Support for Flexible Studies
– Can use Enhanced DCI Books to take advantage of
the features, even if not a Flexible Design study
• Page Tracking not supported
g g pp
• Data-Triggered Rules
–Specify data responses that determine which CRFs,
CPEs, and/or Intervals are expected for each patient
• Copying
–Copy pages from one CPE to another
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24. Enhanced DCI Books…Navigator
Definition DCIs Enhanced DCI Books [Navigator] button
Summary
information
about every
y
CPE in the
study
Click to assign
pages by CPE
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25. Enhanced DCI Books…Navigator
Definition DCIs Enhanced DCI Books [Navigator] button
If ‘rules’
After pages
p g defined
assigned by CPE
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26. Enhanced DCI Books…DCI Rules
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27. Enhanced DCI Books…DCI Rules
Definition DCIs Enhanced DCI Books [DCI Rules] button
DCI Rule: PREG DCI (at all visits) only
( ) y
expected if DEMO.GENDER = “F”
Scroll to right to see ‘Target’ section
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28. What you see in Onsite…DCI Rule
DCI Rule: PREG DCI (at all visits) only
expected if DEMO.GENDER = “F”
PREG not
No data entered expected
yet for DEMO
tf
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29. What you see in Onsite…DCI Rule
R106 DEMO – Gender
entered as FEMALE
Save DEMO and PREG form
now expected for R106
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30. Enhanced DCI Books…Interval
Rules -- #1
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31. Enhanced DCI Books…Interval
Rules -- #2-3
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32. Enhanced DCI Books…Interval
Rules
Definition DCIs Enhanced DCI Books [Interval Rules] button
Interval Rules:
Scroll to right to see ‘Target’ section
1. Once any data is entered for DEMO, the
EOS and STUDY TIME intervals are
enabled (CRFs: TERM, AE, CM)
2. TREATMENT = A (at Baseline CPE,
TRTMNT CRF), enables interval
PHASE1 (CPEs: Week1 & Week3)
3.
3 TREATMENT = B enables interval
B,
PHASE2 (CPEs: Week2 & Week4)
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33. … in Onsite…Interval Rule #1…
Interval Rule #1: Once any data is entered for DEMO, the EOS and
STUDY TIME intervals are enabled (CRFs: TERM, AE, CM)
No other CPEs
enabled yet
No data entered
yet for DEMO
tf
then…
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34. … in Onsite…Interval Rule #1
DEMO data
entered
Rule-defined CPEs
now enabled
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35. … in Onsite…Interval Rule #2…
Interval Rule #2: TREATMENT = A (at Baseline CPE, TRTMNT
CRF), enables interval PHASE1 (CPEs: Week1 & Week3)
CPEs for
Dosing phases
not enabled
No data entered
yet for TRTMNT
tf
then…
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36. … in Onsite…Interval Rule #2
Treatment A entered
CPEs for Week1 &
Week3 now
enabled
Treatment A
T t t
saved
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37. … in Onsite…Interval Rule #3…
Interval Rule #3: TREATMENT = B (at Baseline CPE, TRTMNT
CRF), enables interval PHASE2 (CPEs: Week2 & Week4)
CPEs for
Dosing phases
not enabled
No data entered
yet for TRTMNT
tf
then…
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38. … in Onsite…Interval Rule #3
R107: Treatment B entered
CPEs for Week2 &
Week4 now
enabled
Treatment B
T t t
saved
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39. Enhanced DCI Books…Copying…
Definition DCIs Enhanced DCI Books [Navigator] button
2. Select to copy
pages from one
CPE to another
1. Highlight desired
‘source’ CPE
source
then…
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40. Enhanced DCI Books…Copying…
Select desired
‘target’ CPE from
drop-down list …
Click [Copy]
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41. Enhanced DCI Books…Copying…
Same DCIs now
exist in both visits
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42. Thank you!
Conditional Branching /
g
Conditional Blocks
Q
Questions
Page DCI Access
Flexible Study Design
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43. Contact information
Lori Venable
Principal Consultant
BioPharm Systems, Inc.
734-332-
734-332-1718
lvenable@biopharm.com
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44. Biography
Lori Venable
Lori is a Principal Consultant at BioPharm Systems, Inc. She has been in the industry
for over 22 years, representing a variety of pharma contract and device companies,
years pharma, contract, companies
both large and small.
Lori has been actively involved in Oracle Clinical implementation since 1995, starting
at Parke-Davis as a member of the OC implementation team. Prior to joining
BioPharm S t
Bi Ph Systems in 2004 she was at B t H lth
i 2004, h t Baxter Healthcare’s R’ Renal Di i i f 4
l Division for
years, functioning as Sr. Project Manager overseeing OC implementation and use.
Lori has been an active OHSUG (f.k.a. OCUG) member since its inception in Ann
Arbor in 1996. She served as Co-Chair of OCUG from 2003-2005 and currently y
serves on the Executive Committee. She’s been Co-Chair of the Global Library focus
group from 2002-2004 and 2007-2009, and actively participates on numerous other
focus groups. Lori also co-facilitated and still participates on the OCUG Website
Committee; and has served on (and/or facilitated) the Planning Committee for the
2003 through 2010 annual conferences.
Lori’s primary OC and RDC responsibilities have included: training / coaching /
consulting / troubleshooting; Global Librarian; Study Developer; Validation/Derivation
g g y p
Procedure developer; writing SOPs and guidelines; Application Administrator; and
System Validation.
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