1. OC/RDC 4.6.x -
the Good and
the Bad
Lori Tholkes Venable
16th Annual OHSUG Conference, Oct 2011 – Toronto

2. Topics
• Topics covered in 2010 presentation:
– Page (DCI) Access
– Conditional Branching / Conditional Blocks
– Flexible Study Design
• Topics covered this year
– Extended Text feature
– Some bugs & idiosyncracies discovered in 4.6.0
and 4.6.2
OHSUG 2011 2

3. Topics covered in 2010 presentation
• 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
OHSUG 2011 3

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
OHSUG 2011 4

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
OHSUG 2011 5

6. 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
OHSUG 2011 6

7. 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
OHSUG 2011 7

8. Topics covered this year
• Extended Text feature
•SSome bbugs & idiosyncracies
idi i
discovered in 4.6.0 and 4.6.2
OHSUG 2011 8

9. Extended Text …
• Extended Text Qs support lengthy freeform
text responses
– up to 10,000 characters
– Lengthy comments or narratives
• Cannot display full text in most places
– Q Length you define determines number of
characters displayed in these places
– OC, RDC Classic, Onsite discrepancy details, RDC
Audit hi t
A dit history
– System reserves the first 24 characters for the
attachment prefix
OHSUG 2011 9

10. Extended Text …
• Attachment Prefix
– ATTACHMENT V<x.y>:
– X = version number: number of consecutively
different changes saved in Onsite
– Y = subversion number: number of times focus
leaves the ET field but before ‘save’. (used for
internal auditing only)
• ET fields denoted by yellow note icon in RDC
– Icon not displayed in Graphic Layout Editor
– Be sure to leave space for it (~15 points)
• Once field has data, DEW displays the
, p y
beginning of the text followed by ellipsis (…)
OHSUG 2011 10

11. Extended Text … CRF in Onsite
Yellow Note icon
indicates an
Extended Text field
OHSUG 2011 11

12. Extended Text … CRF in Onsite
Click the icon to open
the Extended Text
window for entry /
y
review / editing
OHSUG 2011 12

13. Extended Text … CRF in Onsite
This is the Extended
Text as entered
This is what will appear
in the CRF window
OHSUG 2011 13

14. Extended Text … in Onsite
This is what appears in the Audit History pane,
Discrepancy Details pane, Data Extract view
OHSUG 2011 14

15. Extended Text … PDR
Patient Data Report –
CRF page
Patient Data Report
– Extended Text
ancillary page
OHSUG 2011 15

16. ET-
ET- Definition Restrictions
• No DVG
• No default
N d f lt response
• Cannot define as Mandatory or Derived
• Cannot d f
define as Repeating QG
• Enterable is unchecked (cannot be checked)
– Can enter/update via RDC Onsite only
– Cannot enter/update via OC, RDC Classic, MCU or
BDL
• Do not use as Indicator Q, trigger Q in flex
study, or source Q in conditional branching
OHSUG 2011 16

17. ET-
ET- Usage Restrictions
• ET Qs can be entered/updated only via RDC
Onsite
– Cannot enter/update via OC, RDC Classic, MCU or
BDL (can use Batch Data Delete to delete ET data)
• System cannot display full response in most
areas
– Truncated response displayed
• Validation Procs have access only to
truncated response
t t d
• Data extract does not support ET Qs
• S
Special characters may not display properly
i l h t t di l l
OHSUG 2011 17

18. ET-
ET- Database Storage
• OC stores responses to ET Qs in 2 tables
– RESPONSES: truncated version
– RESPONSES_LOBS: full text
• RESPONSES
– 24-character Attachment prefix plus response
entered up to defined Q Length
p g
– Number of characters = Q Length - 24
• RESPONSE_LOBS
– VALUE_TEXT_CLOB column
– Full text – maximum of 10,000 characters
– Version number in VERSION_SN column
OHSUG 2011 18

19. Issues / Bugs in 4.6.x …
Note: this is not intended to be a comprehensive list
• Clinical Study States
– Doesn’t always retain the saved checkmarks on
‘DCI Forms Definition Enabled’ & ‘DCI Forms Entry
Enabled’ flags … behaves inconsistently
– Work-around: re-query and re-check/re-save
• Cli i l St d St t – 2nd P
Clinical Study States Pass N t Required
Not R i d
– After running ‘Enable/Disable 2nd Pass Required’
job, Flex
job ‘Flex Study Enabled flag becomes unchecked
Enabled’
– BUG 9301831
– Work-around – re-check/re-save flag (
/ g (can be done
as long as not data entered for the study)
OHSUG 2011 19

20. Issues / Bugs in 4.6.x …
OHSUG 2011 20

21. Issues / Bugs in 4.6.x …
• Study Definition
– Cannot modify the QG Name of a study-level DCM
y Q y
QG
– BUG 10298223 … no work-around
OHSUG 2011 21

22. Issues / Bugs in 4.6.x …
• Lab Assignment Criteria
– Changes made to LAC for RDCMs not retained
g
– BUG 10350892 … no work-around
Change to Lab Tl2462z
not retained
OHSUG 2011 22

23. Issues / Bugs in 4.6.x
• Conditional Branching
– Doesn’t work if the source Q is defined as Multi-
line and the "Represent Disabled Blocks” is set to
GREYED
– BUG 12716558
– Work-arounds - either:
– Set the Multi-line property to “No” … or …
No
– Set the "Represent Disabled Blocks” to HIDDEN
• BDL - OSL
– OSL fails on Linux platform in 4.6.0
– Fixed in 4.6.2
OHSUG 2011 23

24. Contact information
Lori Venable
Principal Consultant
BioPharm Systems, Inc.
734-332-
734-332-1718
lvenable@biopharm.com
OHSUG 2011 24

25. Biography
Lori Venable
Lori is a Principal Consultant at BioPharm Systems, Inc. She has been in the industry
for over 23 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 on the
Executive Committee for several years. 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 OHSUG
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.
OHSUG 2011 25

26. Thank you!
Q
Questions
OHSUG 2011 26