Flexible Study Design in Oracle Clinical and Remote Data Capture 4.6

Working

with Oracle Clinical/RDC:

Flexible Study Design

Steven Rifkin

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

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

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

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

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

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


• 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

Example Study

Screening Completion

A:Cycle 2 A:Cycle 3 A:Cycle 1

B:Cycle 2 B:Cycle 1

Logs

Treatment 1

Treatment 2 Treatment 3

Interim


Treatment 3 Interim

Treatment 4

Arm A

Arm B

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

Example Study: Rule 1



B:Cycle 2 B:Cycle 1

Logs

Treatment 1


Interim


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


Demonstration




B:Cycle 2 B:Cycle 1

Logs

Treatment 1


Interim


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


Demonstration




B:Cycle 2 B:Cycle 1

Logs

Treatment 1


Interim


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


Demonstration




B:Cycle 2 B:Cycle 1

Logs

Treatment 1


Interim


Treatment 3 Interim

Treatment 4

Arm A

Arm B

NO to “give treatment” in any treatment will bypass remaining visits and cycles


Demonstration


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


Demonstration

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

Creating a Flexible Study

Conduct Security Clinical Study States

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

Modeling Intervals

Periods

Treatment

Phase

Completion

Phase Screening

Phase Logs

Phases

Sub-periods

Arm A Arm B

A: Cycle 1 A: Cycle 3 A: Cycle 2 B: Cycle 1 B: Cycle 2

indicate intervals where visits (CPEs) will be placed

Each Interval must have a unique name

Defining Intervals

Intervals are defined from the Easy Study Design Screen

Design Studies Easy Study Design

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

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

Enhanced DCI Books

Definition DCIs Enhanced DCI Books

Buttons will be disabled for non-flexible studies

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

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

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”

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

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

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


Before Demography Entered:

Completion and Logs Intervals

do not appear -- they are now

Targets of 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!


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


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


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


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


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


With DEMOGRAPHY, Completion and Logs Intervals are enabled


If Enrolled in Arm A, Cycle 1 for Arm A enabled


At INTERIM Visit for Arm A Cycle 1, specify YES to continue to next cycle --

and Arm A Cycle 2 Visits are enabled


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


At INTERIM Visit for Cycle 2, specify YES to continue to next cycle --

and Arm A Cycle 3 Visits are enabled

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!

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

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

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!

Q&A

Closing

Thank you for attending!

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Flexible Study Design in Oracle Clinical and Remote Data Capture 4.6