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Master Data

The Master Data module manages system-wide reference data that is shared across studies and artifacts. Study Setup organizes this reference data into four categories:

CategoryDescription
MaterialsThe catalog of physical kit components (collection tubes, shippers, packaging, labels, etc.) reconciled from Infor, the Kit Design File, and the Lab Manual.
SitesStudy Setup-owned location and address records — client sites, labs, depots, and shipment/pickup points — referenced in study artifacts and propagated to downstream systems.
CodeListsEnumerated reference value sets used to constrain study and artifact fields, including externally-owned lists referenced (but not owned) from systems such as BSI and Infor.
SponsorsThe master record of sponsor/client organizations that studies are registered against.

Materials is the primary entity in the current implementation and the only category with a mockup today.

Mockup

Materials list

/materials – Searchable, filterable table of all materials keyed by Infor item number, with class and status filters.

Materials list

Material detail

/materials/:id – Structured detail view showing identity, classification, specimen handling, sourcing, and provenance sections.

Material detail

Entities

Materials

EntityDescription
MaterialA physical kit component with a stable internal material ID and an Infor item number as its ERP crosswalk key. Reconciled across item master, kit design file, and lab manual.
Material ClassCategorizes the material and drives which optional fields apply. Classes: collection-tube, transfer-vial, cryovial, shipper, box, bag, absorbent, gel-pack/coolant, desiccant, label-stock, requisition-form, misc-consumable.
AliasVariant descriptions of a material found across lab manual, KDF, and PSD sources. Multiple aliases may exist per material.
ProvenanceRecords which upstream source last verified the material record: infor-item-master, kit-design-file, or lab-manual.

Material detail sections

SectionFields
IdentityMaterial ID, Infor item #, name, aliases
ClassificationMaterial class, item group, major purchasing class, stock UOM
Specimen handlingAdditive, nominal volume, temperature class (tubes/vials/cryovials only)
HandlingTemperature class (shippers, gel packs, coolants)
SourcingManufacturer, manufacturer part #, active status
ProvenanceSource system, last verified timestamp

Sites

EntityDescription
AddressA Study Setup-owned address record with a type of site, lab, shipment, or pickup. Referenced in study artifacts and propagated to downstream consumers (BSI, Infor).
Sample InstructionA reusable reference instruction (e.g. collection or processing step) maintained as shared reference data and used consistently across Lab Manuals and POPs.

CodeLists

EntityDescription
CodeListA named set of enumerated reference values used to constrain study and artifact fields.
External ReferenceAn externally-owned value (e.g. an Infor item-master selection or a BSI codelist entry) that a study may reference but Study Setup does not own or overwrite.

Sponsors

EntityDescription
SponsorA sponsor/client organization that studies are registered against, providing a shared identity reused across studies and artifacts.

Use Cases

Materials

  • Browse the full materials catalog; filter by material class and active/inactive status.
  • Search materials by Infor item number, name, alias, or manufacturer.
  • View detailed material specifications, classification, and provenance.

Sites

  • Maintain Study Setup-owned address records (create, update) for sites, labs, depots, and shipment/pickup points.
  • Maintain sample instruction reference data (create, update).
  • Propagate approved address changes to downstream targets (BSI, Infor, documents).
  • Detect address drift between downstream targets and the approved Study Setup value.

CodeLists & Sponsors

  • Reference external master/reference values (e.g. Infor item master selections, BSI codelists) from a study without owning them.
  • Assess the impact of a reference data or template change on studies and artifacts.

Notes

  • Infor item number is the crosswalk key to the ERP and is the display-primary identifier in lists (shown in monospace).
  • Aliases capture the variety of names used across source documents; supporting alias search is critical for reconciliation.
  • Active/Inactive status is driven by Infor sourcing; inactive materials should not be used in new kit designs.
  • Provenance tracking is essential for audit: it records which external system last confirmed a material record and when.
  • Address propagation requires an approved workflow to avoid unintended downstream mutations; address drift is detected and surfaced for resolution.
  • CodeLists and External References are referenceable but not overwritable: studies select from externally-owned values rather than mutating them, unless explicitly configured otherwise.
  • Beyond the Materials catalog, the Sites, CodeLists, and Sponsors categories are defined in the model but do not yet have dedicated mockup views.

Events

Events from the master_reference_data bounded context:

EventDescriptionRequirement
ExternalReferenceSelectedAn externally-owned master/reference value was referenced from a studyMD-001
SampleInstructionCreatedA reference sample instruction was createdMD-002
SampleInstructionUpdatedA reference sample instruction was updatedMD-002
AddressCreatedA Study Setup-owned address record was createdMD-003
AddressUpdatedAn address record was updatedMD-003
AddressPropagatedAn approved address change was propagated to downstream targetsMD-004
AddressDriftDetectedA downstream address value diverged from the approved Study Setup valueMD-004
ReferenceDataImpactAssessedThe impact of a reference or template change was assessed across studies and artifactsMD-005