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clinical_trial_csr_template.json
51 lines · skills/clinical-reports/assets/clinical_trial_csr_template.json at 5f2bc03
1{
2 "schema_version": "2.0",
3 "artifact_kind": "clinical_study_report_draft",
4 "draft_status": "BLOCKED_INCOMPLETE_DRAFT_NOT_FOR_FILING_OR_SUBMISSION",
5 "safety_notice": "Populate only from verified aggregate trial outputs and authorized source-fact manifests. Do not invent analyses, efficacy, safety, conclusions, or appendices. Qualified medical, statistical, safety, privacy, quality, and regulatory review is required.",
6 "data_classification": null,
7 "authorized_purpose": null,
8 "authorization_verified": false,
9 "guidance": {
10 "base": "ICH E3",
11 "base_version": "Step 4 1995-11-30",
12 "qa_version": "R1 2012-07-06",
13 "gcp_version_considered": "ICH E6(R3) consolidated 2026-06-16",
14 "regional_adoption_verified": false
15 },
16 "study_metadata": {
17 "protocol_reference": null,
18 "sap_reference": null,
19 "data_cut_reference": null,
20 "analysis_output_reference": null,
21 "coding_dictionary_versions": []
22 },
23 "sections": {
24 "title_page": {"status": "missing", "source_fact_ids": [], "rationale": null},
25 "synopsis": {"status": "missing", "source_fact_ids": [], "rationale": null},
26 "table_of_contents": {"status": "missing", "source_fact_ids": [], "rationale": null},
27 "abbreviations_and_definitions": {"status": "missing", "source_fact_ids": [], "rationale": null},
28 "ethics": {"status": "missing", "source_fact_ids": [], "rationale": null},
29 "investigators_and_administration": {"status": "missing", "source_fact_ids": [], "rationale": null},
30 "introduction": {"status": "missing", "source_fact_ids": [], "rationale": null},
31 "study_objectives": {"status": "missing", "source_fact_ids": [], "rationale": null},
32 "investigational_plan": {"status": "missing", "source_fact_ids": [], "rationale": null},
33 "study_patients": {"status": "missing", "source_fact_ids": [], "rationale": null},
34 "efficacy_evaluation": {"status": "missing", "source_fact_ids": [], "rationale": null},
35 "safety_evaluation": {"status": "missing", "source_fact_ids": [], "rationale": null},
36 "discussion_and_conclusions": {"status": "missing", "source_fact_ids": [], "rationale": null},
37 "tables_figures_graphs_not_in_text": {"status": "missing", "source_fact_ids": [], "rationale": null},
38 "reference_list": {"status": "missing", "source_fact_ids": [], "rationale": null},
39 "appendices": {"status": "missing", "source_fact_ids": [], "rationale": null}
40 },
41 "provenance_manifest": null,
42 "review": {
43 "medical_review": "pending",
44 "statistical_review": "pending",
45 "safety_review": "pending",
46 "privacy_legal_review": "pending",
47 "quality_review": "pending",
48 "regulatory_review": "pending",
49 "submission_authorized": false
50 }
51}