Industry packs
Synthetic study, subject, visit, safety, randomisation and central-lab test data
Preview only · not activatable yet Version 1.0.0 · Complete
Everything on this page works without an account. Prefer a conversation? Request a demo (optional). Missing something? Request a feature.
This pack is installed and passes DataNivra’s pack conformance kit through the real engine, but it cannot be activated yet: no plan includes it yet, the standard agent image does not ship it, the control-plane catalogue does not list it and the hosted sandbox has no synthetic estate for it. You can explore its synthetic records, masking and scenarios on this page and in the browser demo. Tell us if you need it: demand decides which packs become activatable next.
8 cross-system relationships link central_lab, ctms, edc, irt and safety; the pack's masking keeps one pseudonym per identity on every side. For example, edc.subjects.subject_id and irt.randomisations.subject_ref get the same pseudonym.
9 ready-made scenarios generate them on demand, for example: subjects who fail eligibility at screening, with the criterion that was not met; serious, severe adverse events with safety case reports, some unexpected; treatment arms revealed for medical emergencies, with time and reason recorded.
43 columns across 14 entities are classified (direct identifier, PHI, PII, quasi identifier and sensitive) and covered by 3 masking templates you review and approve.
2 certification presets check masking coverage, referential integrity, orphans and row counts before a dataset can be provisioned; a failed dataset is never provisioned.
14 entities across 5 source systems, generated from the pack’s own entity model.
| Entity | References | Columns | Kind |
|---|---|---|---|
| Site | Study | study_id → study_id | Within a system |
| Investigator | Site | site_id → site_id | Within a system |
| EligibilityCheck | Subject | subject_id → subject_id | Within a system |
| Visit | Subject | subject_id → subject_id | Within a system |
| CrfForm | Visit | visit_id → visit_id | Within a system |
| AdverseEvent | Subject | subject_id → subject_id | Within a system |
| ConcomitantMedication | Subject | subject_id → subject_id | Within a system |
| LabResult | LabSample | sample_id → sample_id | Within a system |
| Subject | Site | site_ref → site_id | Across systems (pack relationship template) |
| Subject | Investigator | investigator_ref → investigator_id | Across systems (pack relationship template) |
| Randomisation | Subject | subject_ref → subject_id | Across systems (pack relationship template) |
| KitDispensation | Subject | subject_ref → subject_id | Across systems (pack relationship template) |
| SafetyCase | Subject | subject_ref → subject_id | Across systems (pack relationship template) |
| SafetyCase | AdverseEvent | ae_ref → ae_id | Across systems (pack relationship template) |
| LabSample | Subject | subject_ref → subject_id | Across systems (pack relationship template) |
| LabSample | Visit | visit_ref → visit_id | Across systems (pack relationship template) |
Synthetic data. Every record on this page is synthetic, generated from a fixed seed by the pack's own generator; masked values come from the real masking engine.
subject_id sensitive | site_ref | investigator_ref | screening_number sensitive | initials sensitive | birth_year sensitive | sex sensitive | ethnicity sensitive | consent_date sensitive | status | screen_failure_reason | withdrawal_reason |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Z101-0001 | ZSI-0101 | 2 | SCR-0000001 | KV | 1996 | M | NOT_REPORTED | 2024-08-17 | COMPLETED | — | — |
| Z102-0001 | ZSI-0102 | 3 | SCR-0000002 | XW | 1968 | M | NOT_REPORTED | 2025-03-26 | ENROLLED | — | — |
Template Linked clinical-trial test data (CT_LINKED_TEST_DATA) applied to a synthetic Subject record from edc.subjects.
| Column | Classified as | Before (synthetic) | After masking |
|---|---|---|---|
subject_id | Direct identifier | Z101-0001 | X746-6163 |
screening_number | Direct identifier | SCR-0000001 | FDX-7019580 |
initials | PII, Direct identifier | KV | [REDACTED] |
birth_year | Quasi identifier | 1996 | 1997 |
sex | Quasi identifier | M | [REDACTED] |
ethnicity | Sensitive | NOT_REPORTED | [REDACTED] |
consent_date | PHI, Quasi identifier | 2024-08-17 | 2024-09-01 |
Same pseudonym in two systems. The identifier Z101-0001 appears in edc.subjects.subject_id and in irt.randomisations.subject_ref. Both become X746-6163, so the masked systems still join (relationship CT_RANDOMISATION_SUBJECT).
Masked with a fixed public sample key so this example is reproducible; your data is masked with your own key, referenced from your secret store.
11 runnable scenarios. Preview them in your browser without an account; the hosted sandbox opens when the pack becomes activatable.
Normal CT_ROUTINE_CONDUCT
Ordinary study conduct: enrolled subjects, in-window visits, forms, labs, randomisation and kits
Everyday, valid records: the baseline most tests expect. Children per parent record: 1–3.
Rare CT_SCREEN_FAILURES
Subjects who fail eligibility at screening, with the criterion that was not met
Valid but uncommon business situations that production samples often miss. Children per parent record: 1–3.
Rare CT_SERIOUS_ADVERSE_EVENTS
Serious, severe adverse events with safety case reports, some unexpected
Valid but uncommon business situations that production samples often miss. Children per parent record: 1–3.
Rare CT_EMERGENCY_UNBLINDING
Treatment arms revealed for medical emergencies, with time and reason recorded
Valid but uncommon business situations that production samples often miss. Children per parent record: 1–2.
Rare CT_WITHDRAWALS
Subjects who withdrew consent or were lost to follow-up, with a reason
Valid but uncommon business situations that production samples often miss. Children per parent record: 1–3.
Rare CT_SAMPLE_PROBLEMS
Haemolysed, lost or insufficient central-lab samples without a usable result
Valid but uncommon business situations that production samples often miss. Children per parent record: 1–3.
Rare CT_MISSED_VISITS
Missed visits (no date) and visits outside their protocol window
Valid but uncommon business situations that production samples often miss. Children per parent record: 2–4.
Boundary CT_VISIT_WINDOW_EDGE
Completed visits exactly at the first or last day of their protocol window
Values at the edges of valid ranges (limits, thresholds, extremes). Children per parent record: 2–4.
Boundary CT_LAB_REFERENCE_LIMITS
Lab results exactly at the low or high reference limit (flagged normal)
Values at the edges of valid ranges (limits, thresholds, extremes). Children per parent record: 1–3.
Duplicate CT_DUPLICATE_LAB_TRANSFERS
Lab results delivered twice by the central-lab data transfer under new ids
Records that repeat others under new keys (clean-up and matching tests). Children per parent record: 2–4.
Historical CT_LONG_RUNNING_STUDY
A multi-year, referentially intact study with complete records and no gaps
Old records for archive, migration and retention tests. Children per parent record: 1–3.
Negative tests, kept apart. This scenario produces deliberately broken data for error handling and never passes certification as valid data:
CT_BROKEN_REFERENCES — Dangling cross-system references and invalid values for error-handling testsThe schema the pack expects in each system (also as CREATE TABLE DDL in the downloads). A run produces a masked or synthetic dataset with the same tables, a certification report with the gates of the chosen preset, and an evidence manifest with checksums — the rows stay in your environment.
ctms.studies · 8 columnsA (fictional) interventional study run under one protocol by a sponsor.
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
study_id (key) | VARCHAR(12) | Yes | — |
protocol_number | VARCHAR(16) | Yes | — |
sponsor_code | VARCHAR(16) | Yes | — |
phase | VARCHAR(8) | Yes | — |
therapeutic_area | VARCHAR(24) | Yes | — |
blinding | VARCHAR(16) | Yes | — |
status | VARCHAR(20) | Yes | — |
planned_enrolment | INT | Yes | — |
ctms.sites · 6 columnsAn investigational site taking part in a study.
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
site_id (key) | VARCHAR(10) | Yes | — |
study_id | VARCHAR(12) | Yes | — |
site_number | INT | Yes | — |
country_code | VARCHAR(2) | Yes | — |
status | VARCHAR(10) | Yes | — |
activated_on | DATE | Yes | — |
ctms.investigators · 8 columnsA principal investigator, sub-investigator or coordinator at a site (personal data too).
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
investigator_id (key) | BIGINT | Yes | — |
site_id | VARCHAR(10) | Yes | — |
given_name | VARCHAR(64) | Yes | PII, Direct identifier |
family_name | VARCHAR(64) | Yes | PII, Direct identifier |
email | VARCHAR(128) | No | PII, Direct identifier |
phone | VARCHAR(32) | No | PII, Direct identifier |
registry_number | VARCHAR(16) | No | PII, Direct identifier |
role | VARCHAR(24) | Yes | — |
edc.subjects · 12 columnsA study participant known by a per-study subject number (the natural subset root).
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
subject_id (key) | VARCHAR(12) | Yes | Direct identifier |
site_ref | VARCHAR(10) | Yes | — |
investigator_ref | BIGINT | Yes | — |
screening_number | VARCHAR(12) | Yes | Direct identifier |
initials | VARCHAR(3) | No | PII, Direct identifier |
birth_year | INT | No | Quasi identifier |
sex | VARCHAR(1) | No | Quasi identifier |
ethnicity | VARCHAR(16) | No | Sensitive |
consent_date | DATE | Yes | PHI, Quasi identifier |
status | VARCHAR(20) | Yes | — |
screen_failure_reason | VARCHAR(20) | No | — |
withdrawal_reason | VARCHAR(20) | No | — |
edc.eligibility_checks · 6 columnsOne inclusion or exclusion criterion assessed at screening.
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
check_id (key) | BIGINT | Yes | — |
subject_id | VARCHAR(12) | Yes | Direct identifier |
criterion_code | VARCHAR(4) | Yes | — |
criterion_type | VARCHAR(10) | Yes | — |
met | BOOLEAN | Yes | — |
assessed_on | DATE | Yes | PHI, Quasi identifier |
edc.visits · 7 columnsA protocol visit of a subject (planned on a study day, done within a window or not).
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
visit_id (key) | BIGINT | Yes | — |
subject_id | VARCHAR(12) | Yes | Direct identifier |
visit_code | VARCHAR(16) | Yes | — |
planned_day | INT | Yes | — |
actual_day | INT | No | — |
visit_date | DATE | No | PHI, Quasi identifier |
status | VARCHAR(16) | Yes | — |
edc.crf_forms · 9 columnsA case report form page completed for a visit.
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
form_id (key) | BIGINT | Yes | — |
visit_id | BIGINT | Yes | — |
form_code | VARCHAR(16) | Yes | — |
systolic_bp | INT | No | — |
diastolic_bp | INT | No | — |
sdv_status | VARCHAR(14) | Yes | — |
open_queries | INT | Yes | — |
locked | BOOLEAN | Yes | — |
site_comment | VARCHAR(300) | No | PHI, Sensitive |
edc.adverse_events · 11 columnsAn adverse event recorded on the CRF (serious ones also become safety cases).
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
ae_id (key) | BIGINT | Yes | — |
subject_id | VARCHAR(12) | Yes | Direct identifier |
ae_term_code | VARCHAR(10) | Yes | — |
verbatim_term | VARCHAR(200) | No | PHI, Sensitive |
onset_date | DATE | Yes | PHI, Quasi identifier |
resolved_date | DATE | No | PHI, Quasi identifier |
severity | VARCHAR(10) | Yes | — |
serious | BOOLEAN | Yes | — |
causality | VARCHAR(12) | Yes | — |
outcome | VARCHAR(14) | Yes | — |
action_taken | VARCHAR(18) | Yes | — |
edc.concomitant_medications · 9 columnsA medication the subject takes alongside the study treatment.
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
cm_id (key) | BIGINT | Yes | — |
subject_id | VARCHAR(12) | Yes | Direct identifier |
drug_code | VARCHAR(10) | Yes | — |
indication | VARCHAR(120) | No | PHI, Sensitive |
dose_amount | DOUBLE | No | — |
dose_unit | VARCHAR(6) | No | — |
start_date | DATE | Yes | PHI, Quasi identifier |
end_date | DATE | No | PHI, Quasi identifier |
ongoing | BOOLEAN | Yes | — |
irt.randomisations · 9 columnsRandomisation of a subject to a (blinded) treatment arm, with any emergency unblinding.
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
randomisation_id (key) | BIGINT | Yes | — |
subject_ref | VARCHAR(12) | Yes | Direct identifier |
randomisation_number | VARCHAR(10) | Yes | Direct identifier |
stratum | VARCHAR(10) | Yes | — |
treatment_arm | VARCHAR(8) | Yes | Sensitive |
randomised_at | TIMESTAMP | Yes | PHI, Quasi identifier |
unblinding_status | VARCHAR(10) | Yes | — |
unblinded_at | TIMESTAMP | No | Sensitive |
unblinding_reason | VARCHAR(20) | No | Sensitive |
irt.kit_dispensations · 7 columnsAn investigational-product kit dispensed to a subject at a visit.
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
dispensation_id (key) | BIGINT | Yes | — |
subject_ref | VARCHAR(12) | Yes | Direct identifier |
kit_number | VARCHAR(12) | Yes | Sensitive, Direct identifier |
visit_code | VARCHAR(16) | Yes | — |
dispensed_on | DATE | Yes | PHI, Quasi identifier |
units_dispensed | INT | Yes | — |
units_returned | INT | No | — |
safety.safety_cases · 10 columnsAn individual case safety report raised for a serious adverse event.
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
case_id (key) | BIGINT | Yes | — |
case_number | VARCHAR(14) | Yes | Direct identifier |
subject_ref | VARCHAR(12) | Yes | Direct identifier |
ae_ref | BIGINT | Yes | — |
received_on | DATE | Yes | PHI, Quasi identifier |
seriousness | VARCHAR(20) | Yes | — |
expectedness | VARCHAR(10) | Yes | — |
reporter_name | VARCHAR(96) | No | PII, Direct identifier |
narrative | VARCHAR(600) | No | PHI, Sensitive |
report_status | VARCHAR(10) | Yes | — |
central_lab.lab_samples · 8 columnsA specimen collected at a visit and shipped to the central laboratory.
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
sample_id (key) | BIGINT | Yes | — |
accession_number | VARCHAR(12) | Yes | Direct identifier |
subject_ref | VARCHAR(12) | Yes | Direct identifier |
visit_ref | BIGINT | Yes | — |
specimen_type | VARCHAR(12) | Yes | — |
collected_at | TIMESTAMP | Yes | PHI, Quasi identifier |
received_at | TIMESTAMP | No | PHI, Quasi identifier |
status | VARCHAR(20) | Yes | — |
central_lab.lab_results · 8 columnsOne analyte result of a sample (invented ZLB-... analytes).
| Column | Type | Required | Sensitive classes |
|---|---|---|---|
result_id (key) | BIGINT | Yes | — |
sample_id | BIGINT | Yes | — |
analyte_code | VARCHAR(8) | Yes | — |
result_value | DOUBLE | No | — |
unit | VARCHAR(8) | Yes | — |
reference_low | DOUBLE | Yes | — |
reference_high | DOUBLE | Yes | — |
flag | VARCHAR(2) | Yes | — |
Verified with this pack version: PostgreSQL and Local files (Parquet / CSV). 17 more connectors are compatible by capability: they support what the pack needs, but have not been verified with this pack yet.
| Connector | Status with Clinical Trials |
|---|---|
| Local files (Parquet / CSV) | Verified with this pack |
| PostgreSQL | Verified with this pack |
| Amazon S3 / S3-compatible storage | Compatible by capability (not yet verified with this pack) |
| Apache Kafka (connector in preview) | Compatible by capability (not yet verified with this pack) |
| Azure Blob Storage / Data Lake Storage | Compatible by capability (not yet verified with this pack) |
| Databricks | Compatible by capability (not yet verified with this pack) |
| Generic SQL (SQLAlchemy) | Compatible by capability (not yet verified with this pack) |
| Google BigQuery | Compatible by capability (not yet verified with this pack) |
| HTTP APIs (connector in preview) | Compatible by capability (not yet verified with this pack) |
| IBM Db2 (connector in preview) | Compatible by capability (not yet verified with this pack) |
| Mainframe files (EBCDIC / copybook) (connector in preview) | Compatible by capability (not yet verified with this pack) |
| MariaDB | Compatible by capability (not yet verified with this pack) |
| Microsoft SQL Server | Compatible by capability (not yet verified with this pack) |
| MongoDB (connector in preview) | Compatible by capability (not yet verified with this pack) |
| MySQL | Compatible by capability (not yet verified with this pack) |
| Oracle Database | Compatible by capability (not yet verified with this pack) |
| Parquet files | Compatible by capability (not yet verified with this pack) |
| Snowflake | Compatible by capability (not yet verified with this pack) |
| SQLite (developer evaluation) (connector in preview) | Compatible by capability (not yet verified with this pack) |
A DataNivra agent that reports its installed industry packs (releases after agent 0.3.0); the control plane runs a pack job only on an agent holding the exact active pack version with the catalogued integrity digest.
| Step | Estimate |
|---|---|
| Try the synthetic sandbox No install: sign up and open the sandbox. | Minutes (estimate) |
| Install (or reuse) the agent One Docker command or a Helm chart; outbound HTTPS only. | Under an hour (estimate) |
| Connect a source Register a read-only source through the existing connector workflow. | Under an hour (estimate) |
| Review and approve policies Create drafts from the Clinical Trials templates, review and approve them. | Under an hour (estimate) |
| First certified dataset Run the first job; certification and evidence are produced automatically. | Minutes (estimate) |
CT_STRICTEvery gate; full masking coverage; zero orphaned visits, forms, adverse events, medications, randomisations, kits, safety cases, samples or results; exact row counts. Default for masked clinical-trial test data.
POLICY_COVERAGE: every sensitive column is covered by an approved policyMASKING_COMPLETION: masking finished on every covered columnREFERENTIAL_INTEGRITY: every reference still points at an existing recordSCHEMA_VALIDATION: the output schema matches the source schemaDATA_QUALITY: empty-value ratios stay within the preset’s drift limitROW_COUNT_RECONCILIATION: row counts match the plan within the toleranceORPHAN_DETECTION: no child record lost its parentPROVENANCE: every row is tagged masked or syntheticMANIFEST: a manifest lists every output table with checksumsPOLICY_VERSION: the exact approved policy versions are recordedENGINE_VERSION: the engine version is recordedCHECKSUMS: output checksums are recorded for later verificationIDENTITY_CONSISTENCY: linked identifiers got the same pseudonym in every systemSOURCE_READ_ONLY: the source was only read, never writtenEGRESS_GUARD: no row-level data left the agentCONNECTOR_HEALTH: the connectors stayed healthy during the runCT_SCENARIO_TESTINGEvery gate, with slightly relaxed NULL-ratio drift for scenario datasets whose study states (missed visits, lost samples, blinded randomisations) leave optional fields empty.
POLICY_COVERAGE: every sensitive column is covered by an approved policyMASKING_COMPLETION: masking finished on every covered columnREFERENTIAL_INTEGRITY: every reference still points at an existing recordSCHEMA_VALIDATION: the output schema matches the source schemaDATA_QUALITY: empty-value ratios stay within the preset’s drift limitROW_COUNT_RECONCILIATION: row counts match the plan within the toleranceORPHAN_DETECTION: no child record lost its parentPROVENANCE: every row is tagged masked or syntheticMANIFEST: a manifest lists every output table with checksumsPOLICY_VERSION: the exact approved policy versions are recordedENGINE_VERSION: the engine version is recordedCHECKSUMS: output checksums are recorded for later verificationIDENTITY_CONSISTENCY: linked identifiers got the same pseudonym in every systemSOURCE_READ_ONLY: the source was only read, never writtenEGRESS_GUARD: no row-level data left the agentCONNECTOR_HEALTH: the connectors stayed healthy during the runWhat is missing before you can activate the Clinical Trials pack yourself:
Until then, preview it in the browser demo and download its synthetic asset bundle below.
Tell us you need the Clinical Trials pack or request a feature for it.
Version 1.0.0, 74 files (270.2 KB), all synthetic and generated from the pack itself. Every file’s SHA-256 is listed in MANIFEST.json.
463e998daf62…abc443e51630…a852fcf67c75…
e28639bcb1a2…bf7ce9b1a784…0b9b1c05f2e0…962d9f7247e3…f2bc57432407…39bf78060117…d0a5d63a2957…13a4582f496d…ccf3f49ddc1c…eef9e5e6f249…c10404af201e…e54930bed540…a0728ad1a443…df479db4f4bb…d46c49c10d7c…95e6c852c20a…bb5b56128bd4…ecf305586b81…d55e632a5036…1e25229c4597…7f02a6a87792…9b94c79daccb…1def3d458139…744e46d9e52a…f3688d153d0c…e0a9604fa145…cc9b36c02bb0…c6b3fb4f9f77…b153ffd1cd8c…6a705fb77f79…01adf6a8fb48…a02cc9bc8b35…afc7cef9c5cb…e6766af9a6b3…bb03adfd3b47…4ba6a840731a…d69c874e100b…8edb9405df52…6e8dae1f7558…dff7348202ae…43f3a7922c0a…66eb01d9ec37…350962db19af…f9ab6e44d4ba…ff44295b4a58…fc44841f6d36…a89d2f4d7eb7…20b4cfd5434c…5e7f8d4177f2…8f8d68fa636e…dadc5c5adb37…0d7ba7211c85…14e951a46708…7d274446fcec…176c42a4c915…a9202a2e199c…aa69325eb8b2…3942f50722df…091ec346f6bb…5d62631d4aad…fc6b243015db…555495a21f1f…0ed418cf3a43…a6769bbf7086…e27a7b1ef281…dd03ad8e0f89…d131abe7d57e…6b1ba39e476b…bea4c0486108…The reason codes you can meet on the way, with the recovery step. Every code is also in the error-code catalog.
SANDBOX_PACK_NOT_OFFERED — Synthetic estate not offeredENTITLEMENT_REQUIRED — Plan does not include thisPACK_INTEGRITY_UNVERIFIED — Pack integrity not verifiedPACK_DEPENDENCY_INACTIVE — Required pack not activeAGENT_PACK_MISSING — No agent can run this industry packAGENT_PACK_VERSION_INCOMPATIBLE — Industry pack version differs on the agentAGENT_PACK_INTEGRITY_MISMATCH — Agent pack differs from the cataloguePACK_TEMPLATES_UNAVAILABLE — Pack templates not registeredPACK_TEMPLATE_KEY_REF_REQUIRED — Masking key reference requiredPACK_NOT_ENABLED — Industry pack not enabledThe Clinical Trials pack covers data that laws and industry rules often treat as sensitive. It supports your privacy and governance programmes by keeping those records inside your environment and producing certification evidence; it does not, by itself, make any system or organisation compliant with any law, regulation or standard.
Everything on this page works without an account. Prefer a conversation? Request a demo (optional). Missing something? Request a feature.