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[
{
"Requirement ID": "REQ-21CFR11-001",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "21 CFR Part 11 – Audit Trail: generated code artifact provenance",
"Test Name": "R script contains application semantic version",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-001",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "Python script contains application semantic version",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-001",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "SAS script contains application semantic version",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-001",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "Stata script contains application semantic version",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-002",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "R script contains a valid ISO 8601 generated-at timestamp",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-002",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "Python script contains a valid ISO 8601 generated-at timestamp",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-002",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "SAS script contains a valid ISO 8601 generated-at timestamp",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-002",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "Stata script contains a valid ISO 8601 generated-at timestamp",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-003",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "R script contains the trial protocol identifier",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-003",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "Python script contains the trial protocol identifier",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-003",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "SAS script contains the trial protocol identifier",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-003",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "Stata script contains the trial protocol identifier",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-003",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "results header displays the protocol identifier",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-004",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "R script contains the PRNG seed initialisation statement",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-004",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "Python script contains the PRNG seed initialisation statement",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-004",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "SAS script contains the PRNG seed initialisation statement",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-004",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "Stata script contains the PRNG seed initialisation statement",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-004",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "21 CFR Part 11 – Audit Trail: results grid metadata stamping",
"Test Name": "results header displays the randomization seed used for the schema",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-005",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "Standalone Script",
"Test Name": "Execute scripts/verify_audit_hash.py",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-005",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "should generate the exact same SHA-256 hash as the Python verification utility for the reference mock payload",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-005",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "should successfully verify the audit hash for ",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-006",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "21 CFR Part 11 – Audit Trail: PDF export provenance",
"Test Name": "PDF export contains the application semantic version",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-006",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "PDF export contains a valid ISO 8601 generated-at timestamp",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-006",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "PDF export contains the trial protocol identifier",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-21CFR11-006",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "PDF export contains the PRNG seed value",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-EXPORT-001",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "CSV download filename contains a date component for traceability",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-EXPORT-002",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "PDF export filename matches the expected pattern",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-EXPORT-002",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "",
"Test Name": "should trigger a PDF download when the PDF button is clicked",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-ICH-E6-001",
"Strategic Pillar": {
"Name": "Scientific Validity",
"name": "Scientific Validity"
},
"Suite Name": "",
"Test Name": "{RND:n} produces no duplicate subject IDs across the schema",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-ICH-E9-001",
"Strategic Pillar": {
"Name": "Scientific Validity",
"name": "Scientific Validity"
},
"Suite Name": "Standalone Script",
"Test Name": "Execute scripts/cross-env/verify_python_schema.py",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-ICH-E9-001",
"Strategic Pillar": {
"Name": "Scientific Validity",
"name": "Scientific Validity"
},
"Suite Name": "ICH E9 – Law of Large Numbers: allocation ratio convergence",
"Test Name": "1:1 ratio converges to 50 % per arm across 200 Monte Carlo trials",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-ICH-E9-001",
"Strategic Pillar": {
"Name": "Scientific Validity",
"name": "Scientific Validity"
},
"Suite Name": "",
"Test Name": "should generate a schema and display results grid",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-ICH-E9-002",
"Strategic Pillar": {
"Name": "Scientific Validity",
"name": "Scientific Validity"
},
"Suite Name": "ICH E9 – Stratum Cap Enforcement: dynamic caps are never exceeded",
"Test Name": "per-stratum caps are never exceeded across 100 random seeds",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-ICH-E9-003",
"Strategic Pillar": {
"Name": "Scientific Validity",
"name": "Scientific Validity"
},
"Suite Name": "Standalone Script",
"Test Name": "Execute scripts/cross-env/verify_python_schema.py",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-ICH-E9-003",
"Strategic Pillar": {
"Name": "Scientific Validity",
"name": "Scientific Validity"
},
"Suite Name": "ICH E9 – Block Balance: strict intra-block arm balance",
"Test Name": "every block has exactly the correct count of each arm for a 1:1 ratio with block size 4",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-SBOM-001",
"Strategic Pillar": {
"Name": "Reproducibility",
"name": "Reproducibility"
},
"Suite Name": "CI Workflow",
"Test Name": "Job: sbom",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-ZERO-TRUST-001",
"Strategic Pillar": {
"Name": "Zero-Trust",
"name": "Zero-Trust"
},
"Suite Name": "Zero-Trust Architecture: no outbound network requests",
"Test Name": "schema generation produces zero outbound XHR/Fetch requests to external servers",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-ZERO-TRUST-001",
"Strategic Pillar": {
"Name": "Zero-Trust",
"name": "Zero-Trust"
},
"Suite Name": "",
"Test Name": "CSV export produces zero outbound requests to external servers",
"Status": "UNKNOWN"
},
{
"Requirement ID": "REQ-ZERO-TRUST-001",
"Strategic Pillar": {
"Name": "Zero-Trust",
"name": "Zero-Trust"
},
"Suite Name": "",
"Test Name": "PDF export produces zero outbound requests to external servers",
"Status": "UNKNOWN"
}
]