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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 of 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 . All scheduled activities are relative to this. Modeled somewhat of off CDISC of 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 | epoch | No | An epoch is typically specified in a study protocol and typically signifies some milestone type events within the trial. ie: screening, treatment, followup, etc |
| 2 | cohort | No | A cohort is a way to break up epochs into different groupings. Protocols will occasionally indicate that epochs should be broken up (perhaps in different trial arms to test different dose levels, etc), or this can just purely be an organizational thing |
| 3 | cohort_assignment | No | Binds a Volunteer as Subjects within a Subject within a given cohort along with an Activity Plan. We allow assigning different schedules, and we allow for later scheduling a subject. |
| 4 | activity_plan | No | A schedule of events for a given cohort. |
| 6 | subject | Yes | Someone participating in clinical research within the context of a given study. |
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With this in mind, below is a view of how these elements relate to each other.
Note that form_data can have linkage to forms through scheduled activities or unscheduled.
ItemGroupData has an item_group_repeat_key which is used to track repeats.
| Table | From CDISC? | Notes | |
|---|---|---|---|
| 1 | form | Yes | Basically a container for item groups. |
| 2 | form_data | Yes | Form data represents data collected for a given subject. Instead of storing the scheduled time on this domain, we leverage the relationship to the encapsulated scheduledActivity domain and thus its relationship to the segment. We purposely don't set formRepeatKey in the domain. It is calculated later on when building ODM. |
| 3 | item_group | Yes | A collection of related items in a given form |
| 4 | item_group_ref | Yes | A given item group within a form definition. |
| 5 | item_group_data | Yes | Aggregates item data |
| 6 | item | Yes | Represents the definition of a piece of data collected. |
| 7 | item_ref | Yes | A given item within an item group definition. |
| 8 | item_data | Yes | A piece of collected data |
| 9 | 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 |
| 10 | study_event_data | Yes | Clinical data for a study event (visit) for a given subject |
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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 :1to 1 relationship, meaning there is often 1 base_battery for a single specimen. |
| 4 | base_test_result | 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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| Table | From CDISC? | Notes | |
|---|---|---|---|
| 1 | volunteer | No | Someone who indicates that they are interested in participating in clinical research for the given org. Someone who indicates that they are interested in participating in clinical research for the given org. |
| 2 | volunteer_medical_condition | No | Associates a given condition to a given volunteer |
| 3 | volunteer_note | No | A simple note that can be attached to the volunteer record |
| 4 | volunteer_correspondence | No | Represents a call or text to / from a volunteer by way of Twilio |
| 5 | volunteer_substance_use | No | We purposely don't track SUOCCUR, it allows us to indicate that the vlunteer is not using the substance. |
| 6 | recruitment_appointment | No | Allows for a given volunteer to be assigned to a given time slot |
| 7 | study_site | No | An association between a study and a site |
| 8 | subject | Yes | Someone participating in clinical research within the context of a given study. |
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