making oracle clinical and remote data capture 4.6 features work for you
TRANSCRIPT
Making Oracle Clinical
and Remote Data
Capture 4.6 Features
Work for You
Mari Clovis
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)
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
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
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
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
Terminology
• OC – Oracle Clinical
• RDC – Remote Data Capture
• DCI – Data Collection Instrument
• DCM – Data Collection Module
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
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
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
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
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
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
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
What can a Data Manger See?
Data Manager can see all CRFs (Both Interpretations)
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)
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
Conditional Questions “Grayed Out”
Conditional Questions “Hidden”
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
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
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
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
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
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
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
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 …
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? …
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? …
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? …
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? …
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? …
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?
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
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
Additional Updates
• Customizable Patient Identifier
• Easier assignment of DCI Book
• Continued batch validation when records are locked
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
Effect of the Patient Identifier Field …
Effect of the Patient Identifier Field
Holding Mouse over the Patient icon
will display the Patient Identifier, too
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
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
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.
Demonstration
Q&A
Closing
Thank you for attending!
This webinar will be posted on www.biopharm.com
within 24 hours
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