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clinical_trial_safety_aggregate_template.json

49 lines · skills/clinical-reports/assets/clinical_trial_safety_aggregate_template.json at 5f2bc03

2 "schema_version": "2.0",

3 "artifact_kind": "clinical_trial_safety_aggregate_draft",

4 "draft_status": "BLOCKED_INCOMPLETE_NOT_AN_INDIVIDUAL_CASE_SAFETY_REPORT",

5 "safety_notice": "Aggregate display only. Do not use for individual-case assessment, reportability, transmission, causality, expectedness, seriousness, filing, or submission.",

6 "data_classification": "aggregate",

7 "authorized_purpose": null,

8 "authorization_verified": false,

9 "local_only_handling_confirmed": false,

10 "analysis_metadata": {

11 "protocol_reference": null,

12 "sap_reference": null,

13 "data_cut_reference": null,

14 "analysis_set": null,

15 "counting_rule": null,

16 "threshold_rule": null,

17 "meddra_version": null,

18 "meddra_language": null,

19 "coding_source_reference": null

20 },

21 "input_csv": "adverse_event_aggregate_input_template.csv",

22 "required_columns": [

23 "analysis_set",

24 "treatment_group",

25 "meddra_version",

26 "system_organ_class",

27 "preferred_term",

28 "subjects_affected",

29 "event_count",

30 "denominator"

31 ],

32 "prohibited_content": [

33 "patient identifiers",

34 "subject identifiers",

35 "case identifiers",

36 "verbatim terms",

37 "narratives",

38 "exact event dates",

39 "contact information"

40 ],

41 "provenance_manifest": null,

42 "review": {

43 "safety_coding_review": "pending",

44 "statistical_review": "pending",

45 "privacy_review": "pending",

46 "regulatory_review": "pending",

47 "submission_authorized": false

48 }

49}