Documentation / Connections / Interventions
Biological Interventions
Biological intervention records extend the shared intervention form with biologic-specific regulatory, scientific, storage, and handling fields.
Form shape
Biological interventions use the shared intervention shell plus four additional sections.
| Section | Fields |
|---|---|
| Basics | Name, Type, Sponsors, Description |
| Identifiers | Identifiers |
| Regulatory | Biologic Regulatory Classification, Biologic Subtype |
| Science | Molecular Target, Vector Type, Mechanism of Action, Cell Source, Cell Type |
| Storage | Storage Category, Regulatory Reference, Min Temp, Max Temp, Target Temp, Temp. Unit, Light Sensitivity, Container Type, Shelf Life, Shelf Life Unit, Do Not Freeze, Do Not Refrigerate, Desiccant Required |
| Handling | Cold Chain Monitoring, Special Handling Requirements, Additional Handling Notes, Cold Chain Required, Validated Shipper Required |
What is specific to biological interventions
Biological records carry the extra context needed for antibodies, vaccines, cell therapies, and gene-therapy style products.
| Section | Label | Why it matters |
|---|---|---|
| Regulatory | Biologic Regulatory Classification | Distinguishes BLA, biosimilar, ATMP, RMAT, and related pathways |
| Regulatory | Biologic Subtype | Clarifies what kind of biologic product the record represents |
| Science | Molecular Target | Captures the biological target when applicable |
| Science | Vector Type | Describes the delivery vector for gene-therapy-style products |
| Science | Mechanism of Action | Explains the biologic mode of action |
| Science | Cell Source | Captures the origin of cell-therapy material |
| Science | Cell Type | Captures the therapy cell class such as CAR-T |
| Storage | Storage fields | Captures biologic stability and storage constraints |
| Handling | Handling fields | Captures cold-chain and special handling requirements |