This document provides an overview of a webinar on flexible study design using Oracle Clinical/RDC. The webinar demonstrates how to create a flexible study with conditional logic that enables or disables visits and forms based on entered data. Key aspects covered include defining intervals and visits, setting up rules in an enhanced DCI book to control which visits and forms are expected based on data, and examples showing how visits and forms are dynamically enabled or disabled based on the defined rules. The webinar aims to help both current and new users of Oracle Clinical/RDC understand and leverage the flexible study design capabilities.

1. Working
with Oracle Clinical/RDC:
Flexible Study Design
Steven Rifkin

2. Welcome and Introduction
Steven Rifkin
Chief Application Expert
• 15+ years of experience with
Oracle Clinical, TMS and RDC;
doing Database Design, Study
Conduct and custom
programming

3. Today’s Agenda
Time Topic
10:00-10:05 Welcome and Introduction
10:05-10:10 Who, What and Why?
10:10-10:30 Flexible Study Design Discussion
and Demonstrations
10:30-10:45 Flexible Study Setup
10:45-10:55 Q&A
10:55-11:00 Wrap-up and Contact Information

4. Who, What and Why?
• Who is the intended audience?
– Current OC/RDC users contemplating an upgrade
to version 4.6
– New users of OC/RDC 4.6 who want to learn
more about flexible study design
– Non-OC/RDC users evaluating the features of the
application who perhaps previously reviewed an
earlier OC/RDC version

5. Who, What and Why?
• What features are we examining today?
– Demonstrate a flexible study showing ability to
enable or disable entire forms or visits based on
data responses
– Setting up a Flexible Study via an Enhanced DCI
Book

6. Who, What and Why?
• Why are these features important?
– Organizations need the ability to create a study
schedule which is flexible for more complex
clinical trials
– Especially important when the sites will perform
the entry in an EDC system so that users are
presented only with the forms/visits they need

7. Flexible Study Design …
• Prior to Release 4.6, Oracle Clinical required
strict sequential navigation through a set of
Clinical Planned Events in a DCI book
• Some trials require complex (or flexible)
studies with multiple treatment arms with
different patient groups receiving different
assessments
– Common for Oncology trials

8. Flexible Study Design
• Release 4.6 allows multiple pathways to be
defined in a single DCI Book using
conditional logic based on data for a specific
patient
– Logic will make a new set of visits and CRFs
expected for the patient
• The RDC Onsite interface now has a
dynamic display of newly expected visit and
CRF data as patient data is entered

9. Example Study
Screening Completion
A:Cycle 2 A:Cycle 3A:Cycle 1
B:Cycle 2B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B

10. Rules for Example Study
1. Until any data for Demography form is entered, only
the Screening Visit is expected; after demography
data, the Completion and AE Log visits are expected
2. The Enrollment CRF during the screening Visit will
determine and schedule the Cycle 1 visits in either
Arm A or Arm B
3. Response to a question during Interim Visit in a cycle
with schedule next cycle or end the study for subject
4. If treatment not given during any treatment visit,
subject will leave the study
5. If treatment is given, a new expected form is added
for the visit

11. Example Study: Rule 1
Screening Completion
A:Cycle 2 A:Cycle 3A:Cycle 1
B:Cycle 2B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
Only the Screening Visit is expected until data entered on the Demography
form. Demog entry will enable the Completion Visit and the AE Log

12. Flexible Study Design
Demonstration

13. Example Study: Rule 2
Screening Completion
A:Cycle 2 A:Cycle 3A:Cycle 1
B:Cycle 2B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
Enrollment CRF specifies if Patient is in Arm A or Arm B and schedules cycle 1 treatments

14. Flexible Study Design
Demonstration

15. Example Study: Rule 3
Screening Completion
A:Cycle 2 A:Cycle 3A:Cycle 1
B:Cycle 2B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
YES to “continue to next cycle” in any Interim Visit will schedule the next Treatment Cycle
NO to “continue to next cycle” in any Interim Visit bypass remaining cycles

16. Flexible Study Design
Demonstration

17. Example Study: Rule 4
Screening Completion
A:Cycle 2 A:Cycle 3A:Cycle 1
B:Cycle 2B:Cycle 1
Logs
Treatment 1
Treatment 2 Treatment 3
Interim
Treatment 1 Treatment 2
Treatment 3 Interim
Treatment 4
Arm A
Arm B
NO to “give treatment” in any treatment will bypass remaining visits and cycles

18. Flexible Study Design
Demonstration

19. Example Study: Rule 5
YES to “should drug be given” in any treatment will
schedule a new form to be completed at the visit
HEMATOLOGY FORM
Should Drug be given?
Yes
INFUSION FORM

20. Flexible Study Design
Demonstration

21. Setup of a Flexible Study
1. Identify the Study as Flexible during initial
study setup to set the Clinical Study State
2. Define Intervals and Clinical Planned
Events for the study
3. Set up “Enhanced” DCI Book with DCI
Book Rules

22. Creating a Flexible Study
Conduct  Security  Clinical Study States

23. Intervals
• An Interval is a time span in which there are one or more visits
(Clinical Planned Events)
• Types of Intervals
– Phase
– Periods
– Sub-periods
Modeling the study will involve placing visits in specific Intervals
• Need to plan since visits in an interval will be enabled by logic in Flex
Study Design
Phase
Period
Sub-Period
Intervals

24. Modeling Intervals
Periods
Treatment
Phase
Completion
Phase
Screening
Phase
Logs
Phases
Sub-periods
Arm A Arm B
A: Cycle 1 A: Cycle 3A: Cycle 2 B: Cycle 1 B: Cycle 2
indicate intervals where visits (CPEs) will be placed
Each Interval must have a unique name

25. Defining Intervals
Intervals are defined from the Easy Study Design Screen
Design  Studies  Easy Study Design

26. Defining Clinical Planned Events …
• Each Clinical Planned Event used in your study must be
defined and associated with an Interval (Phase, Period or
Sub-period)
• Each CPE in the study must have a unique name – use a
shorthand to indicate parent phase, period and sub-period
– Treatment 1 visit is defined in multiple intervals
• Visit for Treatment Phase, Arm A, Cycle 1 named AC1 TREATMENT 1
• Visit for Treatment Phase, Arm A, Cycle 2 named AC2 TREATMENT 1
• Visit for Treatment Phase, Arm B, Cycle 1 named BC1 TREATMENT 1
• Visit No. field reflects the sequence in the schedule and will
not reflect the actual sequence of events for a patient
• Duration fields are required but have no effect on the flexible
study definition

27. Enhanced DCI Books …
• Function for Enhanced DCI Books has four
sections
– Navigator: Display screen listing the visits
defined for the study and the interval to which
each is assigned
– Constraints: Limit the unplanned use of specific
DCIs (no change from earlier versions)
– Interval Rules: Define when an interval and its
associated visits and DCIs will become expected
– DCI Rules: Define when a specific DCI becomes
expected in a visit or over all visits
27

28. Enhanced DCI Books
Definition  DCIs  Enhanced DCI Books
Buttons will be disabled for non-flexible studies

29. Enhanced DCI Books: Navigator …
Definition  DCIs  Enhanced DCI Books, [Navigator]
This column will be blank
for non-flexible studies
Select a Visit and click [DCI Book Pages for CPE]
to define which DCIs are expected for that Visit
Counts will update
dynamically as DCIs are
added to Visits and
Rules defined
CPE and Intervals are
pre-populated with
Events for the Study

30. Enhanced DCI Books: Navigator …
Definition  DCIs  Enhanced DCI Books, [Navigator], [DCI Book Pages for CPE]
Enter (or select with LOV) a DCI that may be
expected at this Visit
Use the buttons to
change the Visit to
which DCIs will be
assigned

31. Enhanced DCI Books: Rules
• Book Rules are available only for Flexible Studies
• Rules apply to all patients to which the book is
assigned
• Interval Rules enable an interval and the visits
within the intervals
• DCI Rules enable a specific DCI
– DCI within the current visit
or
– DCI across all visits in which the DCI is defined
• Rules determine “expectedness”

32. Enhanced DCI Books:
Interval Rules
• All Intervals are considered enabled unless a target
of an Interval Rule
• Interval Rules are specified for a specific DCI
– will apply to all visits where the DCI is entered
• Triggers at a DCI determine if an interval is
enabled
– Trigger Conditions
• Trigger an interval when any data is entered in the DCI
• Trigger an interval when there is a specified response to a
question
– Trigger Actions
• Enable one or more named target intervals
• Enable Next Interval
• Bypass to a specified target interval

33. Enhanced DCI Books: Rules
Prior to definition of any Book Rules all DCIs in all
CPEs in all intervals will appear in the RDC surround

34. Enhanced DCI Books:
Interval Rules …
Definitions  DCIs  Enhanced DCI Books, [Interval Rules]
RULE: Enable the Completion and Logs Intervals if any data is entered on Demography

35. Enhanced DCI Books:
Interval Rules …
Before Demography Entered:
Completion and Logs Intervals
do not appear -- they are now
Targets of Rules

36. Enhanced DCI Books:
Interval Rules …
After Demography Entered:
Completion and Logs Intervals
appear -- the Interval Rule
enables them
Treatment intervals still appear
because these are not yet targets
of an interval rule!

37. Enhanced DCI Books:
Interval Rules …
Definitions  DCIs  Enhanced DCI Books, [Interval Rules]
RULE: enable the “A Cycle 1” Interval or the “B Cycle 1” Interval dependent
on the Arm assigned on Enrollment DCI

38. Enhanced DCI Books:
Interval Rules …
Before Enrollment DCI is completed, no visits in either the “A Cycle 1” Interval or
the “B Cycle 1” Interval will be present because both intervals are now targets

39. Enhanced DCI Books:
Interval Rules …
When Enrollment DCI is completed, the visits in either the “A Cycle 1” Interval or
the “B Cycle 1” Interval will be added as enabled
Enrolled in A Arm

40. Enhanced DCI Books:
Interval Rules …
RULE: At last (INTERIM) visit for any cycle, if response to the NEXT_CYCLE_YN
question is NO, bypass to the COMPLETION Interval; if response is YES, then
enable the next sequential interval

41. Enhanced DCI Books:
Interval Rules …
Without DEMOGRAPHY, only Screening Interval is enabled since use of [Next Interval] at
the end of all cycles makes each treatment cycle a target of a rule

42. Enhanced DCI Books:
Interval Rules …
With DEMOGRAPHY, Completion and Logs Intervals are enabled

43. Enhanced DCI Books:
Interval Rules …
If Enrolled in Arm A, Cycle 1 for Arm A enabled

44. Enhanced DCI Books:
Interval Rules …
At INTERIM Visit for Arm A Cycle 1, specify YES to continue to next cycle --
and Arm A Cycle 2 Visits are enabled

45. Enhanced DCI Books:
Interval Rules …
At INTERIM Visit for Arm A Cycle 1, specify NO to continue to next cycle --
and Arm A Cycle 2 Visits are not enabled: bypassed other cycles

46. Enhanced DCI Books:
Interval Rules …
At INTERIM Visit for Cycle 2, specify YES to continue to next cycle --
and Arm A Cycle 3 Visits are enabled

47. Enhanced DCI Books:
Interval Rules
At AC1 Treatment 2, Dose was not given. Only Visits in the Completion and Logs
Intervals are enabled; Visits after the current visit in the current interval are disabled!

48. Enhanced DCI Books:
DCI Rules …
• Within an Interval, rules can be defined to
enable specific DCIs in the visit or across all
visits which contain that DCI
– Only DCIs which contain one or more questions
associated with a DVG can be have DCI rules

49. Enhanced DCI Books:
DCI Rules …
RULE: At a Treatment Visit, if the Dose is given (GIVE_DOSE_YN=YES) then an
infusion form must be made “expected” in that visit

50. Enhanced DCI Books:
DCI Rules
Before GIVE_DOSE_YN was completed,
no INFUSION form expected at visit
After GIVE_DOSE_YN was completed, an
INFUSION form is expected at visit!

51. Q&A

52. Closing
Thank you for attending!
This webinar will be posted on
www.biopharm.com
within 24 hours
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