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The CDISC ODM documentation can be freely downloaded from here. We recommend that anyone intending to work with and understand the ClinSpark data model spend some time getting familiar with the ODM, as it provides valuable insights into both design and intended usage.
Study Data Tabulation Model (CDISC SDTM)
The SDTM defines a standard structure for study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). The ClinSpark data model is influenced by this specification where applicable. The SDTM specification documentation can be found on the CDISC site.
Laboratory Data Model (CDISC LAB)
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- Base Specimen
- Base BatteryBase Test
- Base Result
Additionally the way that ClinSpark handles the concept of Assession comes directly from the CDISC LAB standard, section 3.4.8. Here is the guidance from this section:
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An activity plan is a schedule of events for a given cohort. Activity Plans do not appear in CDSIC. In ODM, there is the notion of a FormRef. However, this design doesn't fit well with ph1 trials where forms are commonly repeated for a given study event (ie many PKs in a given day). As such, FormRef is implicitly available by way Scheduled Activities that are a part of a Segment / Activity Plan.
| Table | From CDISC? | Notes | |
|---|---|---|---|
| 1 | Study | Yes | This element collects static structural information about an individual study. A study is related to a given clinical trial protocol. |
| 2 | Activity Plan | No | A schedule of events for a given cohort. Plans can be assigned to multiple cohorts. A timed plan must have a reference time in order to properly provide UI feedback as segments and scheduled activities are set. Untimed Activity Plan:
Activity Plan fills the role of the FormRef in the ODM. |
| 3 | Segment | Partially | Holds a group of scheduled activities in an activity plan. The segment's offset seconds is essentially the time of the reference event, all scheduled activities are relative to this. Modeled somewhat of off CDISC SDM: "Segments are often seen as the basic building blocks of study design. A segment usually specifies a combination of planned observations and interventions, which may or may not involve treatment, during a period of time." |
| 4 | Scheduled Activity | No | Wraps a form, but adds metadata including timing. |
| 5 | Form | Yes | A form is basically a container for item groups. |
| 6 | Study Event | Yes | A study event represents a given 'visit'. In phase 1 trials this will commonly simply refer to a 'day'. When scheduling forms for a given schedule, the builder must associate the study event. Note: there are common study events that are typically reserved for special events: unscheduled, common (AE, CM), etc |
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| Table | From CDISC? | Notes | |
|---|---|---|---|
| 1 | item_data | Yes | A piece of collected data. Note that lab orders and all results are associated to a given Item Data. You will need to join through Item Data when working with lab data. |
| 2 | base_specimen | Yes (CDISC LAB) | Modeled off of CDISC Lab. A specimen is collected from a subject and assigned to a given item data instance. There can be multiple batteries (test groups) associated to a given specimen. Combines Accession Level and Base Specimen from spec. |
| 3 | base_battery | Yes (CDISC LAB) | A panel related to a specimen - typically this is just a 1:1. |
| 4 | base_test_result | Yes (CDISC LAB)Yes (CDISC LAB) | Combines CDISC Lab BaseTest and BaseResult. These are the results from the lab. |
| 5 | lab_order | No | When specimens are collected, this domain represents that an order is generated. It causes a manifest file to be created (PDF) and potentially a file order to be dumped on to the file system and made available to web services. |
| 6 | lab_interface | No | Encapsulates how to send and receive orders and results from a particular safety lab. Sites may have multiple labs, and if so each of these will have their own lab interface instance. |
| 7 | study_lab_panel | No | Something that can be ordered from item level |
| 8 | specimen_container | No | When setting up samples or labs, users can optionally choose a container. |
| 9 | lab_repeat | No | A domain that allows for the management of lab repeat workflows |
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