1. Status
Status: Released
Version: 1.1.0 - 2026-01
2. Abstract
The human template provides standardized metadata fields for human proteomics experiments. It extends the base template with clinical and demographic metadata required for human samples.
This template is appropriate for:
-
Clinical proteomics studies
-
Healthy human donor samples
-
Cancer and disease biomarker studies
-
Drug treatment and pharmacoproteomics studies
3. Template Hierarchy
base (construction artifact)
└── human (SAMPLE layer - must combine with TECHNOLOGY template)
The human template extends the base template, adding disease annotation and human-specific clinical metadata fields.
|
Important
|
The human template cannot be used alone. You must combine it with a technology template:
|
4. Checklist
4.1. Inherited Columns
All columns from the base template are inherited (source name, organism, organism part, biological replicate, assay name, technology type, instrument, technical replicate, data file). Technology-specific columns (cleavage agent, label, fraction identifier, etc.) come from the technology template (ms-proteomics or affinity-proteomics).
4.2. Human-Specific Columns
| Column | Requirement | Description | Section |
|---|---|---|---|
characteristics[disease] |
REQUIRED | Disease state of the sample | Sample Metadata |
characteristics[age] |
REQUIRED | Age of the donor at sample collection | Sample Metadata |
characteristics[sex] |
REQUIRED | Biological sex of the donor | Sample Metadata |
characteristics[individual] |
RECOMMENDED | Unique identifier for the donor | Individual Identifier |
characteristics[ancestry category] |
RECOMMENDED | Ancestry or ethnic background | Ancestry Category |
characteristics[developmental stage] |
OPTIONAL | Developmental stage (adult, fetal, etc.) | Sample Metadata |
4.3. Clinical Study Columns (Optional)
| Column | Requirement | Description | Section |
|---|---|---|---|
characteristics[pre-existing condition] |
OPTIONAL | Pre-existing medical conditions | Pre-existing Condition |
characteristics[disease staging] |
OPTIONAL | Disease stage (I, II, III, IV) | Disease Staging |
characteristics[clinical data] |
OPTIONAL | Clinical measurements (e.g., glucose level) | Clinical Data |
characteristics[tumor stage] |
OPTIONAL | TNM staging for cancer | Tumor Stage |
characteristics[tumor grade] |
OPTIONAL | Tumor differentiation grade | Tumor Grading |
characteristics[treatment] |
OPTIONAL | Treatment administered | Treatment |
characteristics[compound] |
OPTIONAL | Drug or compound used | Compound |
5. Validation
Validate SDRF files using sdrf-pipelines:
pip install sdrf-pipelines
parse_sdrf validate-sdrf --sdrf_file your_file.sdrf.tsv --template human
6. Example
| source name | characteristics[organism] | characteristics[disease] | characteristics[organism part] | characteristics[age] | characteristics[sex] | characteristics[individual] | characteristics[biological replicate] | assay name | comment[data file] | factor value[disease] |
|---|---|---|---|---|---|---|---|---|---|---|
| patient_001 | homo sapiens | hepatocellular carcinoma | liver | 55Y | male | P001 | 1 | run_001 | patient_001.raw | hepatocellular carcinoma |
| patient_002 | homo sapiens | hepatocellular carcinoma | liver | 62Y | female | P002 | 1 | run_002 | patient_002.raw | hepatocellular carcinoma |
| control_001 | homo sapiens | normal | liver | 48Y | male | C001 | 1 | run_003 | control_001.raw | normal |
7. Detailed Column Guidelines
This section provides detailed guidelines for each human-specific metadata column, organized by category:
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Chapter 8 - Basic donor/patient information
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Chapter 9 - Clinical study metadata
-
Chapter 10 - Tumor characterization
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Chapter 11 - Anatomical location specificity
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Chapter 12 - Biomarker annotations
-
Chapter 13 - Drug treatments
8. General Human Metadata
This section describes basic metadata columns applicable to all human samples, including healthy donors and patients.
8.1. Individual Identifier
| Term | Ontology | Requirement |
|---|---|---|
characteristics[individual] |
EFO:0000542 | Recommended |
Format: Alphanumeric pseudonymized identifier (e.g., patient_001, P023455, donor_1).
|
Important
|
Never use actual patient names. Use pseudonymized identifiers only. Consider GDPR, HIPAA regulations. |
Enables tracking of:
-
Biological replicates from the same individual
-
Matched samples (tumor/normal pairs from same patient)
-
Longitudinal samples (same patient over time)
-
Family/pedigree studies
Examples:
characteristics[individual]: patient_001
characteristics[individual]: individual 234
characteristics[individual]: donor_1
When multiple samples come from the same patient, use consistent identifier:
| source name | characteristics[individual] | characteristics[organism part] |
|---|---|---|
| sample_001 | patient_001 | tumor |
| sample_002 | patient_001 | adjacent normal |
8.2. Ancestry Category
| Term | Ontology | Requirement |
|---|---|---|
characteristics[ancestry category] |
HANCESTRO | Recommended |
| Value | HANCESTRO ID | Description |
|---|---|---|
African |
HANCESTRO:0010 |
African ancestry |
European |
HANCESTRO:0005 |
European ancestry |
East Asian |
HANCESTRO:0009 |
East Asian ancestry |
South Asian |
HANCESTRO:0006 |
South Asian ancestry |
American |
HANCESTRO:0013 |
American ancestry (Indigenous peoples of the Americas) |
|
Note
|
Ancestry category values retain proper noun capitalization (e.g., African, European) since they refer to geographic populations. This is an exception to the general lowercase rule for controlled vocabulary terms. Use the short form (e.g., African) rather than the full label (e.g., African ancestry).
|
Use not available when ancestry is unknown, not applicable for non-human samples or cell lines where ancestry doesn’t apply.
8.3. Body Measurements
| Column | Ontology | Format | Example |
|---|---|---|---|
|
EFO:0004340 |
Numeric (kg/m²) |
25.5 |
|
EFO:0004324 |
{value} kg |
70 kg |
|
EFO:0004339 |
{value} cm |
175 cm |
8.4. Sampling Time Point
| Term | Ontology | Requirement |
|---|---|---|
characteristics[sampling time point] |
EFO:0000688 | Optional |
For longitudinal studies, indicates when sample was collected relative to a reference point.
Values: baseline, week 1, day 7, post-treatment, follow-up.
9. Clinical-Specific Terms
This section describes columns for capturing clinical metadata in human studies, applicable to patient samples regardless of disease type.
9.1. Pre-existing Condition
| Term | Ontology | Requirement |
|---|---|---|
characteristics[pre-existing condition] |
MONDO | Optional |
Comorbidities or pre-existing medical conditions. For multiple conditions, use multiple columns (preferred) or semicolon-separated values.
| Condition | SDRF Value | MONDO ID |
|---|---|---|
High blood pressure |
hypertension |
MONDO:0005044 |
Diabetes |
type 2 diabetes mellitus |
MONDO:0005148 |
Heart disease |
coronary artery disease |
MONDO:0005010 |
Obesity |
obesity |
MONDO:0011122 |
9.2. Disease Staging
| Term | Ontology | Requirement |
|---|---|---|
characteristics[disease staging] |
NCIT, EFO:0000410 | Optional |
Disease staging captures overall disease progression, including cancer staging, chronic disease phases, and severity classifications.
| Value | NCIT ID | Description | Use Case |
|---|---|---|---|
stage I |
NCIT:C27966 |
Early localized disease |
Solid tumors |
stage II |
? |
Locally advanced disease |
Solid tumors (use disease-specific staging) |
stage III |
NCIT:C27970 |
Regional spread |
Solid tumors |
stage IV |
NCIT:C27971 |
Distant metastasis |
Solid tumors |
chronic phase |
? |
Stable chronic disease |
Leukemia, chronic conditions (use disease-specific terms) |
end stage |
? |
Terminal disease phase |
End-stage organ failure (use disease-specific terms) |
|
Note
|
Some staging terms like "stage II", "chronic phase", and "end stage" do not have generic NCIT codes. For these, use disease-specific staging terms when available (e.g., NCIT:C3175 for Chronic Phase CML). |
Examples:
characteristics[disease staging]: chronic phase
characteristics[disease staging]: end stage
characteristics[disease staging]: stage 1
characteristics[disease staging]: mild inflammation
Use not available when staging is unknown, not applicable for non-disease samples.
9.3. Clinical Data
| Term | Ontology | Requirement |
|---|---|---|
characteristics[clinical data] |
EFO:0030083 | Optional |
Free-text or structured clinical details about samples that don’t fit into other structured fields. Use this column for receptor status, treatment history, surgical details, and other clinical annotations.
|
Note
|
Use the term clinical data (EFO:0030083) rather than clinical information to align with EFO ontology.
|
Examples:
characteristics[clinical data]: breast reduction mammoplasty tissue explant
characteristics[clinical data]: lesional
characteristics[clinical data]: estrogen-receptor-positive, progesterone-receptor-positive, epidermal growth-factor-2-negative
characteristics[clinical data]: no cytogenetic response to imatinib
Best Practice: Consider using structured columns (e.g., separate columns for ER/PR/HER2 status) when possible. Use clinical data for additional context that doesn’t fit elsewhere.
9.4. Clinical History
| Term | Ontology | Requirement |
|---|---|---|
characteristics[clinical history] |
EFO:0000352 | Optional |
Captures relevant medical history information for the patient.
10. Cancer-Specific Terms
This section describes columns specific to cancer proteomics studies. These terms are distinct from general clinical staging and provide detailed tumor characterization.
10.1. Tumor Stage (TNM Staging)
| Term | Ontology | Requirement |
|---|---|---|
characteristics[tumor stage]Alt: characteristics[TNM staging] |
NCIT, EFO:0004925 | Optional |
TNM staging describes the extent of cancer spread. Format: T{0-4}N{0-3}M{0-1} where T = tumor size/extent, N = lymph node involvement, M = distant metastasis. Prefix p indicates pathological staging (post-surgery), c indicates clinical staging.
| Value | Description | Staging Type |
|---|---|---|
T1N0M0 |
Small tumor, no lymph nodes, no metastasis |
Clinical or pathological |
pT2pN1M0 |
Pathological staging after surgery |
Pathological |
Type IV |
Stage IV disease |
Roman numeral notation |
IIB |
Stage IIB |
Roman numeral with substage |
Examples:
characteristics[tumor stage]: Type IV
characteristics[tumor stage]: IIB
characteristics[tumor stage]: T3N0M0
10.2. Tumor Grading
| Term | Ontology | Requirement |
|---|---|---|
characteristics[tumor grading]Alt: characteristics[tumor grade] |
NCIT:C28076 | Optional |
Histological tumor grade describes how abnormal cancer cells look under a microscope. Grade correlates with tumor aggressiveness.
| Value | NCIT ID | Description |
|---|---|---|
grade 1 |
NCIT:C28077 |
Well differentiated (low grade) |
grade 2 |
NCIT:C28078 |
Moderately differentiated (intermediate grade) |
grade 3 |
NCIT:C28079 |
Poorly differentiated (high grade) |
grade 4 |
NCIT:C28082 |
Undifferentiated (high grade) |
Examples:
characteristics[tumor grading]: grade 2
characteristics[tumor grading]: grade 3
10.3. Metastasis Site
| Term | Ontology | Requirement |
|---|---|---|
characteristics[metastasis site] |
EFO:0009708, UBERON | Optional |
Location where cancer has spread from the primary site.
| Value | Description |
|---|---|
lymph node |
Metastasis to lymph nodes |
liver |
Hepatic metastasis |
lung |
Pulmonary metastasis |
bone |
Bone metastasis |
brain |
Brain metastasis |
pleura |
Pleural metastasis |
10.4. Tumor Size and Mass
| Term | Ontology | Requirement |
|---|---|---|
characteristics[tumor size]Alt: characteristics[tumor mass] |
EFO:0004134, EFO:0007062 | Optional |
Format: {value} {unit} (e.g., 2.5 cm, 15 mm, 50 g)
10.5. Biopsy Site
| Term | Ontology | Requirement |
|---|---|---|
characteristics[biopsy site] |
EFO:0000288, UBERON | Optional |
Specific anatomical location where biopsy was performed.
Examples: left leg, right breast, Brodmann area 46, liver segment 7
10.6. Survival Time
| Term | Ontology | Requirement |
|---|---|---|
characteristics[survival time] |
EFO:0000714 | Optional |
Format: {value} {unit} (e.g., 24 months, 3 years)
Used for survival analysis studies to track patient outcomes.
10.7. Last Follow Up
| Term | Ontology | Requirement |
|---|---|---|
characteristics[last follow up] |
EFO:0007058 | Optional |
Format: {value} {unit} (e.g., 12 months, 2 years)
Time of last clinical follow-up for longitudinal studies.
10.8. Mitotic Rate
| Term | Ontology | Requirement |
|---|---|---|
characteristics[mitotic rate] |
— | Optional |
Number of mitoses per high-power field. Used for histological grading in some cancer types.
10.9. Cancer Subtype Classifications
Breast cancer subtype (characteristics[breast cancer subtype]):
| Value | NCIT ID | Description |
|---|---|---|
luminal A |
NCIT:C53554 |
ER+/PR+, HER2-, low Ki67 |
luminal B |
NCIT:C53555 |
ER+/PR+, HER2+/- , high Ki67 |
HER2-enriched |
NCIT:C53556 |
ER-/PR-, HER2+ |
triple-negative |
NCIT:C71732 |
ER-/PR-/HER2- |
Other cancer-specific staging systems:
-
characteristics[Dukes stage]- Colorectal cancer staging (A, B, C, D) -
characteristics[Ann Arbor stage]- Lymphoma staging (I, II, III, IV) -
characteristics[Gleason score]- Prostate cancer grading -
characteristics[Weiss grade]- Adrenal cortical carcinoma (low, high)
11. Sampling Site
| Term | Ontology | Requirement |
|---|---|---|
characteristics[sampling site] |
EFO:0000688, UBERON, BTO | Optional |
Specifies the exact sampling location within an organ or tissue, providing more detail than characteristics[organism part]. This column is critical for cancer proteomics studies to distinguish tumor tissue from normal tissue.
11.1. Relationship with characteristics[organism part]
These two columns work together to provide hierarchical anatomical information:
-
characteristics[organism part]= General anatomical structure (e.g., "breast", "liver", "heart") -
characteristics[sampling site]= Specific location or context within that structure (e.g., "tumor", "normal tissue adjacent to tumor", "left ventricle")
11.2. When to Use Sampling Site
Use characteristics[sampling site] when you need to specify:
-
Tumor vs. normal distinction - Critical for matched tumor/normal studies
-
Specific anatomical sub-regions - e.g., "left ventricle" within "heart"
-
Disease-specific locations - e.g., "adenoma" within "colorectum"
-
Developmental zones - e.g., "root differentiation zone" (for plant studies)
11.3. Usage Patterns
Pattern 1: Cancer Studies (Tumor/Normal/Adjacent)
| characteristics[organism part] | characteristics[sampling site] | Use Case |
|---|---|---|
breast |
tumor |
Primary tumor tissue |
breast |
normal tissue adjacent to tumor |
Adjacent normal tissue (may have field effects) |
breast |
tumor-distant section |
Normal tissue from same organ, distant from tumor |
colorectum |
tumor |
Colorectal tumor |
colorectum |
normal tissue |
Normal colorectal tissue |
liver |
normal tissue |
Unaffected liver tissue |
Examples:
characteristics[organism part]: breast
characteristics[sampling site]: tumor-distant section
characteristics[organism part]: colorectum
characteristics[sampling site]: normal tissue adjacent to tumor
Pattern 2: Anatomical Sub-Regions
| characteristics[organism part] | characteristics[sampling site] | Use Case |
|---|---|---|
heart |
left ventricle |
Specific heart chamber |
brain |
frontal cortex |
Specific brain region |
cerebellum |
posterior inferior cerebellum |
Detailed cerebellar location |
colonic mucosa |
sigmoid colon |
Specific colon region |
11.4. Annotation Preferences
There are two valid approaches for anatomical annotation:
Option 1: Most specific level in organism part (preferred for simple cases)
When no additional context is needed, use the most specific anatomical term directly:
characteristics[organism part]: left ventricle
characteristics[organism part]: cerebral cortex
characteristics[organism part]: sigmoid colon
Option 2: General + sampling site (preferred for complex cases)
When you need additional context (e.g., tumor vs. normal), use both columns:
characteristics[organism part]: heart
characteristics[sampling site]: left ventricle
characteristics[organism part]: breast
characteristics[sampling site]: tumor
Guidelines:
-
Prefer most specific level in
organism partwhen simple anatomical annotation is sufficient -
Use
sampling sitewhen you need to capture tumor/normal distinction, disease context, or other qualitative information -
Do NOT use multiple organism part columns - This pattern is not recommended
-
Use lowercase for all values
12. Phenotype and Biomarkers
For general phenotype annotation guidelines applicable to all organisms, see Sample Metadata Guidelines - Phenotype.
This section focuses on human-specific biomarker applications of the phenotype column.
12.1. Clinical Biomarkers
| Term | Ontology | Requirement |
|---|---|---|
characteristics[phenotype] |
PATO, HP | Optional |
In clinical proteomics, phenotype is commonly used to capture biomarker status for patient stratification:
| Biomarker Type | Example Values | Clinical Application |
|---|---|---|
Hormone receptor status |
ER positive, PR negative |
Breast cancer treatment selection |
Growth factor receptors |
HER2 positive, EGFR positive |
Targeted therapy eligibility |
Immune markers |
PD-L1 high, CD8+ infiltrating |
Immunotherapy response prediction |
Stem cell markers |
CD34 positive, ALDH+ |
Stem cell identification |
Examples:
characteristics[phenotype]: HER2 positive
characteristics[phenotype]: ER positive
characteristics[phenotype]: triple negative
characteristics[phenotype]: PD-L1 high expression
12.2. Drug Response in Human Studies
For pharmacoproteomics and precision medicine studies:
characteristics[phenotype]: gefitinib sensitive
characteristics[phenotype]: cisplatin resistant
characteristics[phenotype]: tamoxifen resistant
characteristics[phenotype]: imatinib responder
12.3. Genotype for Human Variants
| Term | Ontology | Requirement |
|---|---|---|
characteristics[genotype] |
EFO | Optional |
For human genetic variants, use genotype to capture specific mutations:
characteristics[genotype]: BRCA1 mutation carrier
characteristics[genotype]: KRAS G12D mutant
characteristics[genotype]: wild type
characteristics[genotype]: TP53 R175H
12.4. Biomarker vs Genotype vs Phenotype
| Concept | Column | Example | Use Case |
|---|---|---|---|
Genetic mutation |
|
BRCA1 mutation |
Known genetic variant |
Protein expression status |
|
HER2 positive |
Biomarker measured by IHC/proteomics |
Drug sensitivity |
|
cisplatin resistant |
Functional drug response |
13. Treatment and Perturbation Metadata
This section describes columns for capturing drug treatment, compound exposure, and perturbation information. These fields are critical for pharmacoproteomics studies and treatment comparison experiments.
13.1. Treatment
| Term | Ontology | Requirement |
|---|---|---|
characteristics[treatment] |
NCIT | Optional |
General treatment or intervention applied to samples. Use for treatment categories when more general than specific compounds.
| Value | NCIT ID | Description |
|---|---|---|
chemotherapy |
NCIT:C15632 |
Chemical drug treatment |
immunotherapy |
NCIT:C15262 |
Immune-based treatment |
radiation therapy |
NCIT:C15313 |
Radiation-based treatment |
surgery |
NCIT:C17173 |
Surgical intervention |
untreated |
NCIT:C48660 |
No treatment applied |
Examples:
characteristics[treatment]: untreated
characteristics[treatment]: Mycobacterium tuberculosis H37Rv whole cell lysate
characteristics[treatment]: LPS stimulation
Use untreated for no treatment, not available when unknown.
13.2. Compound
| Term | Ontology | Requirement |
|---|---|---|
characteristics[compound] |
ChEBI, NCIT, EFO | Optional |
Chemical compound, drug, or biological agent applied to samples. Use ChEBI ontology for standardized compound identification.
| Compound | ChEBI ID | Drug Class |
|---|---|---|
doxorubicin |
CHEBI:28748 |
Anthracycline chemotherapy |
cisplatin |
CHEBI:27899 |
Platinum chemotherapy |
tamoxifen |
CHEBI:41774 |
Selective estrogen receptor modulator |
dexamethasone |
CHEBI:41879 |
Glucocorticoid |
none |
EFO:0001461 |
Control (no compound) |
Examples:
characteristics[compound]: tamoxifen (CHEBI_41774)
characteristics[compound]: dexamethasone
characteristics[compound]: none (EFO:0001461)
characteristics[compound]: lipopolysaccharide
characteristics[compound]: interferon gamma
Best Practice: Include ChEBI accession in format compound_name (CHEBI:XXXXX) when available.
13.3. Dose
| Term | Ontology | Requirement |
|---|---|---|
characteristics[dose] |
UO | Optional |
Format: {value} {unit}
| Concentration Unit | Example | Use Case |
|---|---|---|
nanomolar |
100 nanomolar |
Cell culture experiments |
micromolar |
10 micromolar |
In vitro studies |
millimolar |
1 millimolar |
High concentration studies |
mg/kg |
5 mg/kg |
Animal studies (body weight-based) |
ng/ml |
50 ng/ml |
Serum/media concentration |
μg/ml |
10 μg/ml |
Protein/antibody concentration |
Examples:
characteristics[dose]: 100 nanomolar
characteristics[dose]: 10 micromolar
characteristics[dose]: 50 nanogram per millilitre
13.4. Treatment Time
| Term | Ontology | Requirement |
|---|---|---|
characteristics[treatment time] |
UO | Optional |
Format: {value} {unit} where unit is hour, day, week, month (or h, d, w abbreviations)
Duration of treatment exposure.
| Value | Description |
|---|---|
24 hour |
One day treatment |
4 hours |
Short-term treatment |
5 days |
Multi-day treatment |
2 weeks |
Extended treatment |
Examples:
characteristics[treatment time]: 24 hour
characteristics[treatment time]: 4 hours
characteristics[treatment time]: 5 days
13.5. Treatment Status
| Term | Ontology | Requirement |
|---|---|---|
characteristics[treatment status] |
— | Optional |
Values: pre-treatment, on treatment, post-treatment, treatment naive.
13.6. Treatment Response
| Term | Ontology | Requirement |
|---|---|---|
characteristics[treatment response] |
NCIT:C50995 | Optional |
| Value | NCIT ID | Description |
|---|---|---|
complete response |
NCIT:C4870 |
No detectable disease (complete remission) |
partial response |
NCIT:C18058 |
Tumor size reduced (partial remission) |
stable disease |
NCIT:C18213 |
No significant change |
progressive disease |
NCIT:C17747 |
Disease progression |
13.7. Genetic Modification
| Term | Ontology | Requirement |
|---|---|---|
characteristics[genetic modification] |
EFO | Optional |
Describes the method or type of genetic modification applied to samples (particularly relevant for engineered cell lines and model organisms).
|
Note
|
This is distinct from characteristics[genotype] which describes WHAT variant is present. genetic modification describes HOW the modification was done.
|
| Value | EFO ID | Description |
|---|---|---|
gene knock out |
EFO:0000506 |
Complete gene deletion |
gene knock down |
EFO:0000513 |
Gene expression reduction (siRNA, shRNA) |
gene overexpression |
EFO:0000514 |
Increased gene expression |
transfection |
EFO:0000515 |
DNA introduction (non-viral) |
transduction |
EFO:0000516 |
DNA introduction (viral) |
wild type genotype |
EFO:0005168 |
No genetic modification |
Examples:
characteristics[genetic modification]: gene knock out (EFO:0000506)
characteristics[genetic modification]: AML1-ETO fusion gene transduction
characteristics[genetic modification]: transduction of hTERT, HPVE6
characteristics[genotype]: DNMT3a R882 mutant
characteristics[genotype]: wild type genotype
13.8. Complete Treatment Annotation Example
For comprehensive pharmacoproteomics annotation, combine compound, dose, and treatment time:
| source name | characteristics[compound] | characteristics[dose] | characteristics[treatment time] | characteristics[phenotype] |
|---|---|---|---|---|
sample_treated_1 |
tamoxifen (CHEBI:41774) |
1 micromolar |
48 hour |
tamoxifen sensitive |
sample_treated_2 |
tamoxifen (CHEBI:41774) |
1 micromolar |
48 hour |
tamoxifen resistant |
sample_control |
none (EFO:0001461) |
not applicable |
not applicable |
control |
14. Best Practices
14.1. General Guidelines
-
Protect privacy - Never include identifiable patient information. Use pseudonymized identifiers only.
-
Use ontology terms - Prefer MONDO for diseases, NCIT for staging/treatments, ChEBI for compounds, PATO for phenotypes.
-
Be consistent - Use the same format for all samples in a dataset.
-
Document unknowns - Use
not availablerather than leaving cells empty. -
Include temporal context - Specify when measurements were taken relative to treatment.
-
Ensure regulatory compliance - Follow GDPR, HIPAA, and other data protection regulations.
14.2. Clinical Proteomics Best Practices
-
Separate disease from staging - Use
characteristics[disease]for the condition andcharacteristics[disease staging]for progression. -
Use sampling site for tumor/normal - Distinguish tissue types using
characteristics[sampling site](e.g., "tumor", "normal tissue adjacent to tumor"). -
Track matched samples - Use consistent
characteristics[individual]identifiers for samples from the same patient. -
Document treatment context - Combine
characteristics[compound],characteristics[dose], andcharacteristics[treatment time]for complete treatment annotation. -
Use phenotype for biomarkers - Capture molecular markers and drug response status in
characteristics[phenotype].
14.3. Cancer-Specific Best Practices
-
Avoid embedding staging in disease - Don’t use "high grade serous ovarian cancer" in disease column; use separate staging columns.
-
Use standard staging systems - Prefer TNM notation for solid tumors, Ann Arbor for lymphomas.
-
Include grading when available - Tumor grade provides important prognostic information.
-
Document metastasis - Use
characteristics[metastasis site]for metastatic samples.
15. Additional Terms
This section contains optional metadata terms that may be useful in specific contexts.
15.1. Smoking Status
| Term | Ontology | Requirement |
|---|---|---|
characteristics[smoking status] |
NCIT:C19796 | Optional |
| Value | NCIT ID | Description |
|---|---|---|
never smoker |
NCIT:C65108 |
Never smoked |
former smoker |
NCIT:C65107 |
Previously smoked, now quit |
current smoker |
NCIT:C65106 |
Currently smoking |
15.2. Menopausal Status
| Term | Ontology | Requirement |
|---|---|---|
characteristics[menopausal status] |
NCIT:C16151 | Optional |
For female patients. Values: pre-menopausal, peri-menopausal, post-menopausal.
16. References
16.1. Disease and Clinical Ontologies
-
MONDO Disease Ontology: https://mondo.monarchinitiative.org/
-
NCI Thesaurus (NCIT): https://ncithesaurus.nci.nih.gov/
-
EFO Experimental Factor Ontology: https://www.ebi.ac.uk/efo/
16.2. Anatomy and Cell Ontologies
-
UBERON Anatomy Ontology: https://obofoundry.org/ontology/uberon.html
-
Cell Ontology (CL): https://obofoundry.org/ontology/cl.html
16.3. Phenotype and Quality Ontologies
-
PATO Phenotype Ontology: https://obofoundry.org/ontology/pato.html
16.4. Chemical and Treatment Ontologies
-
ChEBI Chemical Entities: https://www.ebi.ac.uk/chebi/
16.5. Population and Ancestry
-
Human Ancestry Ontology (HANCESTRO): https://www.ebi.ac.uk/ols4/ontologies/hancestro
16.6. Staging Systems
-
TNM Classification: AJCC Cancer Staging Manual
-
Ann Arbor Staging: Lymphoma staging system