approaches to schedule of activities (soa) specification

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 Withdrawn From Study Visit?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 Richardsonandy.richardson@zenetar.com

www.Zenetar.com