Document Types

A Document Type is a recognized kind of clinical document in Study Setup. Every document that enters or exits the system — whether an uploaded source file or a generated output artifact — is an instance of exactly one Document Type.

Document Types are the shared vocabulary that connects Source Ingestion, Templates, and the study Outputs workflow. Each module references Document Types as a stable identifier; this page is the single source of truth for the full set.

Recognized Document Types

Document Type	Abbreviation	Has Output Templates	Ingestion Pipeline
Statement of Work	SOW	—	Yes
Protocol	Protocol	—	Yes
Project Specification Document	PSD	Yes	Yes
Laboratory Manual	Lab Manual	Yes	Yes
Kit Design File	KDF	Yes	Yes
Protocol Operations Plan	POP	Yes	Yes
Kit Request Form	KRF	Yes	Yes
Sample Request Form	SRF	Yes	Yes

Input types are source documents uploaded to a study; they feed the ingestion pipeline but are never generated by Study Setup. Output types are artifacts generated from a study model; they are the deliverables of the study setup process.

Note on historical processing

For new studies, typically only SOW and Protocol are uploaded. For historical studies, data will be ingested from a variety of sources, including PSD, POP, Lab Manual, KDF, KRF, SRF, and other documents.

Relationships

Templates

Output Document Types each have zero or more Templates associated with them. Multiple templates may exist for the same type (e.g. different sponsors, legacy formats, or customized variants). SOW and Protocol are input-only types and have no templates.

See Templates for template authoring, versioning, and lifecycle.

Ingestion Pipelines

Every Document Type has one Ingestion Pipeline — a specialized set of LLM parsers that extract structured study model attributes from documents of that type. Input types (SOW, Protocol) are the primary extraction sources for go-forward studies; output types (PSD, POP, Lab Manual, KDF, etc.) are processed when reconstructing historical studies.

See Source Ingestion for pipeline details.

Study Outputs

For each study, the SDL selects a template per output Document Type, forming the study's set of Study Outputs. A study need not have an output for every Document Type; types can be added or removed from the study's outputs as needed.

See Studies – Outputs for the output management workflow.

Relationships Diagram

erDiagram
    DocumentType ||--o{ Template : "has (output types only)"
    DocumentType ||--|| IngestionPipeline : "has one"
    Study ||--o{ StudyOutput : "has"
    StudyOutput }o--|| DocumentType : "is of type"
    StudyOutput }o--|| Template : "uses"

Notes

Canonical Names

The table above establishes the canonical full names for each type. PRD articles (ingestion.md, templates.md) have been aligned to these names ("Kit Design File", "Protocol Operations Plan").