Drug Interventions
Drug intervention records extend the shared intervention form with drug-specific regulatory, scientific, storage, and handling fields.
Form shape
Drug interventions use the shared intervention shell plus four additional sections.
| Section | Fields |
|---|---|
| Basics | Name, Type, Sponsors, Description |
| Identifiers | Identifiers |
| Regulatory | Drug Regulatory Classification, Therapeutic Class |
| Science | Mechanism of Action |
| 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 drug interventions
Drug records add the classification and operational fields teams need for medicinal products.
| Section | Label | Why it matters |
|---|---|---|
| Regulatory | Drug Regulatory Classification | Distinguishes IND, NDA, OTC, orphan, fast-track, and related pathways |
| Regulatory | Therapeutic Class | Groups the drug by therapeutic use or mechanism family |
| Science | Mechanism of Action | Explains how the drug works for protocol and review context |
| Storage | Storage fields | Captures medicinal product stability and temperature limits |
| Handling | Handling fields | Captures cold-chain and shipping controls |
Shared with every intervention
- Basics always capture the intervention identity.
- Identifiers always support governed external or internal codes.
- Trials and media stay available as relationship tabs on the intervention record.
Trial dose units
Trial-specific administration units retain their existing stored values. The server adds a precise UCUM reference for supported choices, including explicit aliases such as mcg to ug and IU to [IU]. This changes neither the dose amount nor the meaning of an unchanged historical record. The source is the pinned UCUM 2.2 authoring subset, not a complete imported terminology release.
Cell and vector-genome choices remain available without a claimed UCUM binding. Unchanged legacy values remain unversioned if their original reference was unversioned. New USDM quantities retain a saved UCUM reference as an alias of the existing target unit code; this is not a new UCUM-to-CDISC projection rule. Product-level dosage metadata is outside this trial-administration change.