Building new tools needs clear vision. Kirsten Langendorf explains the shared vision of the CDISC 360 Project and the A3 Suite.
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The A3 suite (Figure 1), which contains an MDR and a Study Workbench (SWB), has been developed (and is being continuously improved) with the same vision in mind as the CDISC 360 project. Much of the vision of the CDISC 360 project is alive and already working today in the A3 suite.
Figure 1: Components of A3 Suite including future extensions
About the CDISC 360 Project
Looking at the description of the CDISC 360 project description the purpose is to: “support standards-based, metadata-driven automation across the end-to-end clinical research data lifecycle and represents a significant next step toward realizing an increased return on investment in standards implementation that our stakeholders expect – substantially improved efficiency, consistency, and re-usability.”
Three use cases will be assessed as part of the CDISC 360 project. The A3 suite is currently able to demonstrate many of these automated functions and thereby support the vision of the CDISC 360 project. These will be described below.
Use Case 1 (Populate MDR)
Create end-to-start specification – Demonstrate the ability to produce a standards-based, machine-readable specification for the data and analysis artefacts to be created in the study, see Figure 2.
Figure 2: End-2-end MDR content
A3 MDR Supporting Use Case 1
The overall functionality of the A3 MDR is:
- CDISC terminology and sponsor defined terminology
- CDISC models and IGs (e.g. SDTM/SDTMIG, ADaM/ADaMIG) and sponsor versions of the CDISC models (domains)
- Biomedical concepts
- definition of data to be collected in relation to relation to procedures being conducted on the subject in a study. e.g. the measurement of systolic blood pressure and the additional attributes (standing/sitting, unit)
- Standard Case Report Forms (CRFs)
- Collection of Biomedical concepts or questions on a logical page including instructions to user for completing the form.
Impact Assessment
In the MDR, the impact of the managed items (terminology, BCs, forms and domains), when a new model or a new terminology is being introduced, can be assessed. Based on the impact assessment, a new version of biomedical concepts, forms and sponsor defined terminology may be required.
The standards are made available for the other tools (e.g. the A3 SWB) for re-use and to ensure standardization of data collection.
Being built on graph technology, the different standards and metadata is linked together behind the scenes.
This allows for easy (push button) impact assessment (see Figure 3.1 & 3.2), changes to terminology (see Figure 4), and obtaining the annotated CRF (see Figure 5) for a standard form in the MDR by a simple push of a button – no annotation needed (see figure 6).
Figure 3.1 Impact Assessment
Figure 3.2: Impact Assessment
Figure 4: Terminology Changes
Figure 5: Push Button aCRF
Figure 6: Annotate CRF of standard form in the MDR
A3 MDR & SWB Supporting Use Case 2 (Specific Study Metadata)
Generate start-to-end metadata – Demonstrate the ability to generate study-specific artefacts given the standards specification from Use Case 1, see Figure 7 and Figure 8.
Figure 7: Select Study Metadata from MDR
Figure 8: Study Build based on Study Metadata
The A3 SWB uses the A3 MDR metadata to specify what to collect on a study. The overall functionality of the A3 SWB is:
The A3 SWB is a tool designed with the Data Manager in mind to help setting up data collection for studies in an organisation. In the A3 SWB, metadata on what data to collect is specified, see Figure 9.
Figure 9 SoA for a sample study
The A3 SWB uses the forms defined in A3 MDR. The output of this process is one or more export file(s) to the EDC system (see Figure 10), facilitating a quicker EDC system setup for the study, and specification to other data collections means (Lab and ePRO).
Figure 10 EDC export files and export for define.xml by push of a button
The CRF can be displayed, printed as a report or exported for e.g. EDC load. In addition, the annotated CRF (aCRF) can be displayed/exported (see Figure 11) and the define.xml can be generated and exported (see Figure 10). The define.xml picks all relevant metadata from the forms selected to populate domains, value level metadata and controlled terms, see Figure 12.
Figure 11 Generated aCRF for the sample study(excerpt)
Figure 12 Automated metadata for define.xml
The support for the trial design domains will be available in a future release.
A3 SWB & MDR Supporting Use Case 3 (Study metadata-driven data transformation)
Transform data start-to-end – Demonstrate the ability to process data and execute data transformations given the study specification from Use Case 2, see Figure 13.
Figure 13 Automate data transformation using study metadata
This end-to-end use case is in alignment with the A3 vision. However, being built on graph technology, we envision that the actual data will co-exist with the metadata for the study. Viewing and using data, e.g. in BI and SCE tools, will then access the data from the graph by a query. Putting the subject data together with the study metadata has been demonstrated earlier in this blog.
The CDISC 360 project is trying to break down the data silos that are often seen in organisations to ensure better data and more effective data processing and traceability. This is very much in alignment with the vision of the A3 Suite. If we have sparked your interest, please get in touch and we can discuss our solution to the challenges in your organisation.