Making Oracle Clinical and Remote Data Capture 4.6 Features Work for You
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Transcript of Making Oracle Clinical and Remote Data Capture 4.6 Features Work for You
![Page 1: Making Oracle Clinical and Remote Data Capture 4.6 Features Work for You](https://reader035.fdocuments.us/reader035/viewer/2022062513/557acf6dd8b42a2c0f8b4f62/html5/thumbnails/1.jpg)
Making Oracle Clinical
and Remote Data
Capture 4.6 Features
Work for You
Mari Clovis
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Welcome & Introductions
Mari Clovis Principal Consultant
• 12+ years of experience in clinical trial design and creation
• Experienced with Oracle Clinical, Thesaurus Management System (TMS) and Remote Data Capture (RDC)
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Today’s Agenda
Time Topic
2:00-2:05 Welcome and Introductions
2:05-2:10 Who, What and Why?
2:10-2:15 Meeting Data Blinding Requirements
2:15-2:25 Conditional Branching Options
2:25-2:35 Flexible Studies
2:35-2:40 Additional minor updates and features
2:40-2:50 Demonstration
2:50-3:00 Q&A
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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 a preview of the features
– Non-OC/RDC Users evaluating the features of the application who perhaps previously reviewed an earlier OC/RDC version
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Who, What and Why?
• What features are we examining today?
– Ability to blind or secure data from update by particular users
– Ability to enable or skip sections of forms based on data responses
– Ability to enable or disable entire forms, visits or intervals based on data responses
– Support for adaptive/flexible trials
– Additional updates
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Who, What and Why?
• Why are these features important?
– Many of the features found in the version 4.6 release address issues users have encountered with data blinding, site ease of use, and the ability to create a study schedule which is flexible for more complex clinical trials
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Terminology
• OC – Oracle Clinical
• RDC – Remote Data Capture
• DCI – Data Collection Instrument
• DCM – Data Collection Module
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Why is Data Blinding Useful?
• Information added by the sponsor which has no clinical value but may influence results should not be visible at the sites
• Data loaded from labs or other sources may have potential to “unblind” a study and is of no significance in patient care
• May want independent interpretation of data without influence of existing interpretation
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DCI Blinding
• Blinding of DCIs is controlled by membership in specific User Groups
• System level configuration controls the default access of User Groups
– Unrestricted sees all DCIs by default
– Restricted sees no DCIs by Default
• For each study, DCIs can be hidden or made available to a User Group
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DCI Blinding
• Can also control whether a group member’s normal study/site privileges apply to a specific DCI of if they will only be allowed to browse the form
• All Setup is in OC but the blinding is effective only for viewing in RDC
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DCI Blinding Example
• X-rays sent to two Radiologists for reading and entry of results via RDC – Don’t want either Radiologist to see the other’s
interpretation
– Don’t want either Radiologist to see any data other than Demography (browse only)
– Want Site Coordinators to see (but not update) one interpretation only
– Want Data Managers to see both interpretations
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What can Radiologist 1 See and Do?
Radiologist 1 sees only DCI for his
Measurements which he can update
Radiologist 1 sees only DEMOG CRF for browse
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What can Radiologist 2 See and Do?
Radiologist 2 sees only DCI for her
Measurements which she can update
Radiologist 2 sees only DEMOG CRF for browse
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What can a Site Coordinator See and Do?
Site Coordinator cannot see
Measurement 1, and can only browse
second interpretation
Coordinator can See and update all other CRFs
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What can a Data Manger See?
Data Manager can see all CRFs (Both Interpretations)
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Conditional Branching
• Conditional Branching controls cursor navigation and enabling of sections of a form based upon a data response given
– Example: Responding to the Gender field on the Demography form with value of Female enables additional fields regarding Pregnancy
– If the appropriate trigger response is not given the site user cannot enter data into the conditional fields and the cursor skips those fields (if they are displayed)
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Conditional Branching
• Conditional Branching previously available in OC Character Data Entry (and Classic RDC entry)
• Not available in RDC Onsite(except for indicator question structures) until V46
• Set-up for RDC utilizes existing Conditional Branching screens and additional definition in the graphic layout editor
• Choice of “hiding” or “graying out” the disabled conditional questions
– Choice can be at the study level
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Conditional Questions “Grayed Out”
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Conditional Questions “Hidden”
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Flexible Study Design …
• Some trials require complex (or flexible) studies with multiple treatment arms with different patient groups receiving different assessments
– Common for Oncology trials
• Prior to Release 4.6, Oracle Clinical required strict sequential navigation through a set of Clinical Planned Events in a DCI book
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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
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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 1 Treatment 2
Treatment 3 Interim
Arm A
Arm B Treatment 4
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Example Study – Rules to Implement
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 1 Treatment 2
Treatment 3 Interim
Arm A
Arm B
Any Data entered on the Demography form in
the Screening visit will enable Visits/Forms in
the Completion and Log Intervals
Treatment 4
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Example Study – Rules to Implement
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 1 Treatment 2
Treatment 3 Interim
Arm A
Arm B
The response to a field on the Enrollment form in the
Screening visit enables either Treatment Arm A or B
Treatment 4
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Example Study – Rules to Implement
The response of No to the question “Was a dose
given” or a response of No to the question “Will the
patient continue to the next cycle” routes the user to
the Completion Interval (bypassing intervening visits)
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 1 Treatment 2
Treatment 3 Interim
Arm A
Arm B
No
Dose
No Next
Cycle
Treatment 4
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Example Study – Rules to Implement
HEMATOLOGY FORM
Was a Dose Given?
The response of Yes to the question
“Was a dose given” will enable an
additional Infusion form
Yes
INFUSION FORM
Rules can also be created to control the
occurrence of particular forms in the study
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Flexible Study: What do you see? …
Without DEMOGRAPHY data, only CRFs at screening are enabled since not known if PT
enrolled and on which arm …
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If Enrolled in Arm A, Cycle 1 for Arm A enabled and, if enrolled, also have an End
of Study Visit and an AE Visit
Flexible Study: What do you see? …
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At INTERIM Visit for Arm A Cycle 1, specify YES to continue to next cycle --
and Arm A Cycle 2 Visits are enabled
Flexible Study: What do you see? …
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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
Flexible Study: What do you see? …
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At INTERIM Visit for Cycle 2, specify YES to continue to next cycle --
and Arm A Cycle 3 Visits are enabled
Flexible Study: What do you see? …
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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!
Flexible Study: What do you see? …
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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!
Flexible Study: What do you see?
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Flexible Study Design
• In Oracle Clinical a study is designated as being “Flexible”
• The study Intervals and Visits are defined
• The forms are assigned to each visit through an Enhanced DCI Book
• Rules are applied through the Enhanced DCI Book
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Enhanced DCI Books
Definition DCIs Enhanced DCI Books
Rules added to the book via Interval Rules and
DCI Rules (These two buttons will be disabled for
non-flexible studies)
DCIs added to the book via the Navigator
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Additional Updates
• Customizable Patient Identifier
• Easier assignment of DCI Book
• Continued batch validation when records are locked
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Custom Patient Identifier Field
• Identifier is an optional field in the OnSite Surround which contains user configured Patient Information
– Displayed and searchable on the Patient List (Home Page) and Casebook List (Casebook Page)
• Maybe useful for Flex Studies for display of Patient Treatment Arms
• Availability of the field is defined at the Study Level
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Effect of the Patient Identifier Field …
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Effect of the Patient Identifier Field
Holding Mouse over the Patient icon
will display the Patient Identifier, too
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Group Assignment of DCI Books
• Oracle Clinical 4.6 adds the option to assign or reassign groups of Patient Positions by range, site, or study
• In prior versions, assignment typically occurred one patient position at a time – time consuming for studies with large patient population
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Group Assignment of DCI Books
Enter a Patient Range
Enter Patients at a Particular Site
Select All the Patients for the Study
Choose Patients assigned to a
Particular Book, All Books or
Unassigned Choose the Target Book
and Click [Assign Book]
Assignment Options
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Batch Validation Processing
• Change to the way batch validation processes locked documents. If batch validation is attempted while a user is entering/updating data, the system will skip the document and process the next time Batch Validation is executed. A warning message will appear in the output file that the document is skipped or locked.
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Demonstration
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Q&A
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Closing
Thank you for attending!
This webinar will be posted on www.biopharm.com
within 24 hours
Contact BioPharm
United States: +1 877 654 0033 United Kingdom: +44 (0) 1865 910200
Email Address: [email protected]