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trial_protocol_reporting_checklist.json
70 lines · skills/clinical-reports/assets/trial_protocol_reporting_checklist.json at 5f2bc03
1{
2 "schema_version": "2.0",
3 "artifact_kind": "randomized_trial_protocol_reporting_manifest",
4 "draft_status": "BLOCKED_INCOMPLETE_REPORTING_CHECKLIST_NOT_A_PROTOCOL_OR_ETHICS_APPROVAL",
5 "safety_notice": "This manifest tracks SPIRIT reporting-item coverage only. It does not design, approve, register, conduct, amend, or submit a trial protocol.",
6 "data_classification": "aggregate",
7 "authorized_purpose": null,
8 "authorization_verified": false,
9 "guidance": {
10 "base": "SPIRIT 2025",
11 "item_count": 34,
12 "statement_and_explanation_checked": false,
13 "applicable_extensions": [],
14 "applicable_extensions_reviewed": false,
15 "extension_conflicts_resolved_by_methodologist": false
16 },
17 "protocol_metadata": {
18 "authorized_protocol_reference": null,
19 "protocol_version": null,
20 "registry_reference": null,
21 "ethics_record_reference": null
22 },
23 "checklist_items": {
24 "S01": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
25 "S02": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
26 "S03": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
27 "S04": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
28 "S05": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
29 "S06": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
30 "S07": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
31 "S08": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
32 "S09": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
33 "S10": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
34 "S11": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
35 "S12": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
36 "S13": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
37 "S14": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
38 "S15": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
39 "S16": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
40 "S17": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
41 "S18": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
42 "S19": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
43 "S20": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
44 "S21": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
45 "S22": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
46 "S23": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
47 "S24": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
48 "S25": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
49 "S26": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
50 "S27": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
51 "S28": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
52 "S29": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
53 "S30": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
54 "S31": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
55 "S32": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
56 "S33": {"status": "missing", "source_fact_ids": [], "official_item_locator": null},
57 "S34": {"status": "missing", "source_fact_ids": [], "official_item_locator": null}
58 },
59 "not_applicable_rationales": {},
60 "participant_timeline_source_fact_ids": [],
61 "provenance_manifest": null,
62 "review": {
63 "investigator_sponsor_review": "pending",
64 "methodologist_review": "pending",
65 "statistical_review": "pending",
66 "safety_review": "pending",
67 "ethics_regulatory_review": "pending",
68 "protocol_approved": false
69 }
70}