approaches to schedule of activities (soa) specification
TRANSCRIPT
Approaches to Schedule of Activities (SOA) Specification for Automated Implementation
PHUSE EU Connect 2020: ML05
Andy Richardson Zenetar Ltd
PHUSE EU Connect 2020: ML05[ ML05:2 ]
SOA SpecificationIntroduction
The Clinical Trial Protocol Schedule of Activities lies at the heart of each clinical study
The Schedule of Activities (SOA), usually in table form, is the primary study specification document
The SOA always requires various degrees of interpretation and manual intervention before optionally functional tools and processes are ready
Industry initiatives - CDISC 360, Transcelerate Digital Data Flow & HL7 FHIR – all recognise the central role of the SOA in driving efficient operational implementation
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SOA SpecificationIntroduction
Presentation Overview
A review of the role of the SOA and its constituent parts
To develop an alternative method for SOA specification
Demonstrate the method can generate machine-readable SOA specifications
Lessons learned and other thoughts
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SOA SpecificationSOA Parts
HL7 BR&R Connectathon 2018-08 Scenario 4Lilly Xanomeline Clinical Study Protocol
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SOA SpecificationRole of the SOA
SOA Automation Use Cases
Automatic semi-automatic EDC / CDM / PRO study builds Data conversions (Raw – SDTM – ADaM)EHR data specificationData source integration
IVRS/IWRS integrationClinical supplies managementClinical monitoring
Site proceduresCompliance alertsSubject visit diaries and reminders
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SOA SpecificationProtocol SOA
The ideal sequence of subject review and data collection pointstogether with…
The activities or data that are requested to be collected at this time point
… which are explicitly stated or requested by implication
and subject to…
The following caveats depending upon certain subject or timing conditions
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SOA SpecificationSOA Clinical Operations
Distinct contact ‘visit’ types Unscheduled Contact? Withdrawn From Study Visit?
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SOA SpecificationSOA Subject Path / Subject Experience
Protocol SOA: Visit 1
Site Task Order: Visit 1
Department Administrative Procedures
Site Study Team
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SOA SpecificationSOA Definition
Objective: To establish a flexible and extensible SOA model to support any SOA use case
• Able to accommodate all reasonable study SOA specifications• Able to generate directly or indirectly machine-readable definitions• Not restricted to defining only regulated clinical trials
Terms of Reference
• Focus on the specification of a subjects possible study paths• Limited (in the first instance) to addressing the SOA scheduling • Target SOA specifications using FHIR and/or CDISC standards
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SOA SpecificationSOA Definition
Solution needs to be network, graph based using state modelling principles
INTERACTION path – define once in protocol SOAs
ACTIVITY paths – defined for each INTERACTION in protocol SOA
ACTIVITY consistency – same task(s) at each INTERACTION
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SOA SpecificationSOA Definition
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SOA SpecificationSOA Definition
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SOA SpecificationSOA Definition
Interactions
Activities
Visit CyclePath PriorityVisit Timings
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SOA SpecificationSOA Implementation: Example
Specification
Expanded SOA
SOA Table
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SOA SpecificationSOA Implementation: Example
Specification
Expanded SOA
SOA Table
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SOA SpecificationSOA Implementation: Example
Specification
Detail
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SOA SpecificationSOA Implementation: Example
Expanded SOA(Hierarchical Layout)
start
finish
Expanded SOA(Organic Layout)
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SOA SpecificationSOA Implementation: Example
start
finish
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SOA SpecificationSOA Implementation: Example
Recovered SOA Table
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SOA SpecificationSOA Implementation: Example
SOA Table As Input
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SOA Specification
Automatically Generated CompactSpecification
SOA Implementation: Example
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SOA Specification
Re-Generated SOA Table
SOA Implementation: Example
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SOA SpecificationMachine Readable SOA: Objective
SOA Table
Compact SOA
SOA Table
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SOA SpecificationMachine Readable SOA
SOA Graph to FHIR PlanDefinitionHow can a SOA graph (adjacency matrix) be represented using FHIR PlanDefinition elements?
Study ID
SOA Action Type (Interaction or Activity)
Interactions (Visits) or Activities
Visit-ID
Timing details
FHIR Grouping and Selection Behaviour (controls next step in SOA – only 1 choicepermitted)
Next step options
Tasks to be completed for this Action (Reference to FHIR Activity Definition)
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SOA SpecificationMachine Readable SOA
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SOA SpecificationSummary
This work was undertaken to review the role and constituent parts of the SOA as the primary driver for operational implementation
An alternative, network based, methodology for SOA specification has been developed that has the potential to reduce manual intervention and interpretation
Practical examples of the approach have been developed and machine-readable SOA specifications using FHIR standards generated
To exploit the approach fully more work is needed to reflect and extend to basic model to include all use cases
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SOA SpecificationContact Details
Thank you for your interest in this work.
If you have any questions you are welcome to contact me at…
Andy [email protected]
www.Zenetar.com