{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "High-dose green tea extract · Evidence Check for increased liver failure or death",
  "language": "en",
  "translation_date": "2026-10-12",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "What are the original clinical-event question and subclaim verdict?",
      "needed": "Actual text, grade and note of the increased liver failure/death subclaim",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Actual text, grade and note of the increased liver failure/death subclaim; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish the original verdict from current preparation and user-review events"
    },
    {
      "item_id": "N02",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are the parent liver-enzyme safety question and selected clinical events distinguished?",
      "needed": "Distinguish parent claim/analysis endpoints from direct liver-failure/death evidence",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Distinguish parent claim/analysis endpoints from direct liver-failure/death evidence; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Display biochemical harm and direct clinical events as separate questions"
    },
    {
      "item_id": "N03",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are the clinical liver-failure definition and assessment pathway provided?",
      "needed": "Clinical liver-failure diagnosis, severity, confirmation and prespecified event definition",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Clinical liver-failure diagnosis, severity, confirmation and prespecified event definition; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Present actual clinical liver-failure confirmation criteria and collection pathways"
    },
    {
      "item_id": "N04",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are death causes, types and confirmation methods provided?",
      "needed": "All-cause death, liver-related death, cause confirmation and event definitions",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "All-cause death, liver-related death, cause confirmation and event definitions; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish direct liver-failure, all-cause death and liver-related death materials"
    },
    {
      "item_id": "N05",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are actual liver-failure events, group denominators and follow-up available?",
      "needed": "Liver-failure events, confirmation, observation and withdrawal denominators by group",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Liver-failure events, confirmation, observation and withdrawal denominators by group; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Present direct events together with actual observed denominators"
    },
    {
      "item_id": "N06",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are direct death events, denominators, effects and intervals available?",
      "needed": "Deaths, person/time denominators, comparative effects and uncertainty",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Deaths, person/time denominators, comparative effects and uncertainty; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Present original mortality-comparison values and gaps separately"
    },
    {
      "item_id": "N07",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Is missing direct-event collection distinguished from a null-effect test?",
      "needed": "Actual collection, reporting, analysis scope and original interpretation",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Actual collection, reporting, analysis scope and original interpretation; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish non-establishment/unverified information from actual null-effect tests"
    },
    {
      "item_id": "N08",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "What were the actual analysis-population eligibility and baseline enzymes?",
      "needed": "Age, sex, baseline condition, eligibility and exclusion criteria",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Age, sex, baseline condition, eligibility and exclusion criteria; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish applicability to normal-baseline participants from other clinical populations"
    },
    {
      "item_id": "N09",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are safety-analysis denominators distinguished from original assignment/exclusions?",
      "needed": "Flow from assignment through baseline, initial testing and safety analysis",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Flow from assignment through baseline, initial testing and safety analysis; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Present baseline, early withdrawal, observation and analysis denominators separately"
    },
    {
      "item_id": "N10",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "What were the actual research exposure and duration of high-dose capsules?",
      "needed": "Original EGCG, capsules, actual research exposure, interruption and duration specifications",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Original EGCG, capsules, actual research exposure, interruption and duration specifications; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish research identity from actual exposure and clinical-event follow-up"
    },
    {
      "item_id": "N11",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are placebo/product composition and concurrent exposures verified?",
      "needed": "Active/placebo composition, matching, caffeine, concurrent exposure and baseline differences",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Active/placebo composition, matching, caffeine, concurrent exposure and baseline differences; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish selected exposure from other possible causes and comparison conditions"
    },
    {
      "item_id": "N12",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Do at least 800 mg/four months and lower-dose contexts answer the same direct question?",
      "needed": "Original other-dose/duration/population materials and direct clinical events",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Original other-dose/duration/population materials and direct clinical events; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish dose/duration/population enzyme signals from gaps in direct clinical events"
    },
    {
      "item_id": "N13",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are traditional brewed green tea and concentrated capsules distinguished?",
      "needed": "Direct evidence by exposure form, composition and duration",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Direct evidence by exposure form, composition and duration; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Record formulation-specific applicability separately"
    },
    {
      "item_id": "N14",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "What is the current evidence scope for randomization and masking?",
      "needed": "Randomization, concealment, role-specific masking and actual outcomes measured",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Randomization, concealment, role-specific masking and actual outcomes measured; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish enzyme-analysis methods from direct clinical-event assessment"
    },
    {
      "item_id": "N15",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are the original efficacy primary endpoint and prespecified safety analysis distinguished?",
      "needed": "Planned hierarchy of breast density, safety, liver failure and death",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Planned hierarchy of breast density, safety, liver failure and death; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish planned efficacy, enzyme harm and clinical-event hierarchies"
    },
    {
      "item_id": "N16",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are registration identifiers distinguished from actually read plans?",
      "needed": "NCT00917735, registration history, protocol, SAP and event plans",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "NCT00917735, registration history, protocol, SAP and event plans; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish preserved identifiers from external reading and direct-event plans"
    },
    {
      "item_id": "N17",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Do CTCAE grades differ from clinical liver-failure diagnoses?",
      "needed": "Definitions of biochemical liver-function grades and clinical disease",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Definitions of biochemical liver-function grades and clinical disease; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Separate test-abnormality severity from clinical-event diagnosis"
    },
    {
      "item_id": "N18",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Was the parent moderate-or-worse liver-function effect reused?",
      "needed": "Distinguish original enzyme-harm events/denominators/effects from direct endpoints",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Distinguish original enzyme-harm events/denominators/effects from direct endpoints; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Present parent harm effects and selected clinical-event effects separately"
    },
    {
      "item_id": "N19",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are all ALT events distinguished from person-level liver-function abnormalities?",
      "needed": "Test events, people, repeated tests, time-specific denominators and original values",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Test events, people, repeated tests, time-specific denominators and original values; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish repeated-test events from person-level and clinical events"
    },
    {
      "item_id": "N20",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are mean ALT/AST changes clinical-event effects?",
      "needed": "Separate enzyme changes, between-group differences/intervals and clinical-event outcomes",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Separate enzyme changes, between-group differences/intervals and clinical-event outcomes; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Separate biochemical changes from clinical harm outcomes"
    },
    {
      "item_id": "N21",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are severe enzyme cases direct clinical liver failure or death?",
      "needed": "Individual test results, clinical course, assessment and severity",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Individual test results, clinical course, assessment and severity; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish enzyme-grade cases from direct clinical outcomes"
    },
    {
      "item_id": "N22",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "What is the causal scope of withdrawal/rechallenge responses?",
      "needed": "Test values, exposure/time relationships and direct clinical-event courses",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Test values, exposure/time relationships and direct clinical-event courses; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish re-exposure enzyme responses from direct clinical-event courses"
    },
    {
      "item_id": "N23",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Do study safety monitoring and interruption criteria differ from clinical-event observation?",
      "needed": "Study context of testing schedules, exposure changes, follow-up and event confirmation",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Study context of testing schedules, exposure changes, follow-up and event confirmation; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish the study safety-monitoring context from clinical-event observation scope"
    },
    {
      "item_id": "N24",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Can twelve months establish long-term/rare clinical outcomes?",
      "needed": "Long-term liver-failure/death follow-up, exposure and rare-event denominators",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Long-term liver-failure/death follow-up, exposure and rare-event denominators; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Separate short-term test harms from long-term clinical-event gaps"
    },
    {
      "item_id": "N25",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Do other causes, concurrent exposures and withdrawals remain in clinical-event interpretation?",
      "needed": "Liver-disease causes, other exposures, event timing and interruption/withdrawal data",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Liver-disease causes, other exposures, event timing and interruption/withdrawal data; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Present causal possibilities together with alternative causes and missing-data limits"
    },
    {
      "item_id": "N26",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are MGTT reports, registration, sibling sheets and EFSA independent trials?",
      "needed": "Links between papers, registrations, assessments, included trials and populations",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Links between papers, registrations, assessments, included trials and populations; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish reports/assessment documents from actual trials and participant units"
    },
    {
      "item_id": "N27",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are enzyme signals in other patients same-condition replication?",
      "needed": "Materials by disease, exposure, duration, comparator and direct endpoint",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Materials by disease, exposure, duration, comparator and direct endpoint; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish unidentified bibliographic context from direct replication of the same question"
    },
    {
      "item_id": "N28",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are selected non-establishment and the parent D verdict distinguished?",
      "needed": "Original notes/grade reasons and the enzyme-harm/clinical-event boundary",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Original notes/grade reasons and the enzyme-harm/clinical-event boundary; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Display original grades and unverified boundaries for different questions"
    },
    {
      "item_id": "N29",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are funding, manufacturing, quality testing and product support distinguished?",
      "needed": "Funding, manufacturing, quality testing, product/company role disclosures",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Funding, manufacturing, quality testing, product/company role disclosures; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Distinguish public research funding from commercial manufacturing/quality involvement"
    },
    {
      "item_id": "N30",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Do unreported company support and author conflict declarations certify independence?",
      "needed": "Actual research/analysis/writing/publication funding, author relationships and permissions",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Actual research/analysis/writing/publication funding, author relationships and permissions; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Separate disclosure wording from unverified roles and independence"
    },
    {
      "item_id": "N31",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are summary reading and external abstracts/full text/registration/plans distinguished?",
      "needed": "Material-specific links, preserved originals and actual reading status",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Material-specific links, preserved originals and actual reading status; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Display summary reading and external non-reading by material type"
    },
    {
      "item_id": "N32",
      "question_type": "Harm comparison · Direct clinical-event gaps",
      "question": "Are Korean/English text, axes, evidence date, corrections, original candidates and preparation events separated?",
      "needed": "Preserve the full original parent, selected record, metadata and freezing/application",
      "role": "Required",
      "role_reason": "Preparation condition showing the scope and direct gaps between the selected liver-failure/death claim and currently available liver-enzyme harm evidence.",
      "application_exception": "Unverified direct clinical events are not filled with enzymes, test grades, other populations, products or time points.",
      "criterion": "Preserve the full original parent, selected record, metadata and freezing/application; separate actual observations from unestablished outcomes in the original material, without creating new numbers, effects, clinical verdicts or independent certifications.",
      "basis": "Preserved harm-family application conditions and method links retained for preparation; not completed full-definition review or official method certification",
      "condition_origin": "Preparation conditions developed under the existing content-review responsibility policy; not passage through an automatic quality/review gate",
      "proposed_research": "Record existing verdicts/corrections separately from current preparation/user review"
    }
  ]
}