SEND (Preview)
The Standard for Exchange of Nonclinical Data (SEND) extends SDTM for animal studies.
Note
SEND support is planned for a future release of Trial Submission Studio.
What is SEND?
SEND (Standard for Exchange of Nonclinical Data) provides:
- Standardized format for nonclinical (animal) study data
- Based on SDTM structure
- Required for FDA nonclinical submissions
- Supports toxicology and pharmacology studies
SEND vs SDTM
| Aspect | SDTM | SEND |
|---|---|---|
| Subjects | Human | Animal |
| Studies | Clinical trials | Nonclinical studies |
| Domains | Clinical domains | Nonclinical domains |
| Requirements | NDA, BLA | IND, NDA (nonclinical) |
SEND Domains
Special Purpose
| Domain | Name |
|---|---|
| DM | Demographics |
| DS | Disposition |
| TA | Trial Arms |
| TE | Trial Elements |
| TS | Trial Summary |
| TX | Trial Sets |
Findings
| Domain | Name |
|---|---|
| BW | Body Weight |
| BG | Body Weight Gain |
| CL | Clinical Observations |
| DD | Death Diagnosis |
| FW | Food/Water Consumption |
| LB | Laboratory Results |
| MA | Macroscopic Findings |
| MI | Microscopic Findings |
| OM | Organ Measurements |
| PC | Pharmacokinetic Concentrations |
| PP | Pharmacokinetic Parameters |
| TF | Tumor Findings |
| VS | Vital Signs |
Interventions
| Domain | Name |
|---|---|
| EX | Exposure |
Key Differences from SDTM
Subject Identification
- USUBJID format differs for animals
- Species and strain information required
- Group/cage identification
Domain-Specific Variables
SEND includes nonclinical-specific variables:
- Species, strain, sex
- Dose group information
- Study day calculations
- Sacrifice/necropsy data
Controlled Terminology
SEND uses specific CT:
- Animal species
- Strain/substrain
- Route of administration (nonclinical)
- Specimen types
Planned Features
When SEND support is added, Trial Submission Studio will provide:
SEND Import/Mapping
- Support nonclinical data formats
- Map to SEND domains
- Handle group-level data
SEND Validation
- SEND-IG compliance checking
- Nonclinical-specific rules
- Controlled terminology for SEND
SEND Export
- XPT V5 format
- Define-XML for SEND
- Submission-ready packages
Current Workarounds
Until SEND support is available:
-
Manual Mapping
- Use current SDTM workflow
- Manually adjust for SEND differences
- Export to XPT
-
External Tools
- Use specialized nonclinical tools
- Validate with SEND validators
SEND Versions
| Version | Description |
|---|---|
| SEND 3.1.1 | Current FDA standard |
| SEND 3.1 | Previous version |
| SEND 3.0 | Initial release |