{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "MRI-first targeted-biopsy pathway · Long-term prostate-cancer mortality equivalence — Evidence Check",
  "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "Existing content review remains incomplete.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Selected long-term mortality question and original values",
      "needed": "Selected existing question, grade/note, parent context and presence of score/status/axes",
      "role": "Required",
      "role_reason": "A production item distinguishing Selected existing question, grade/note, parent context and presence of score/status/axes to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Selected existing question, grade/note, parent context and presence of score/status/axes: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Update research linking the original question with additional material; no new search, calculation or trial was performed here."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Definition of long-term prostate-cancer mortality",
      "needed": "Definition, adjudication and follow-up time for the selected mortality outcome",
      "role": "Required",
      "role_reason": "A production item distinguishing Definition, adjudication and follow-up time for the selected mortality outcome to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Definition, adjudication and follow-up time for the selected mortality outcome: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; custom application; M03 §3.2.4; custom extension boundary; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A follow-up research proposal distinguishing the detection pathway from long-term mortality; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Initial biopsy and actual population",
      "needed": "Pathway-trial recruitment conditions and the mortality-question population",
      "role": "Required",
      "role_reason": "A production item distinguishing Pathway-trial recruitment conditions and the mortality-question population to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Pathway-trial recruitment conditions and the mortality-question population: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A follow-up research proposal on population conditions and the application scope of long-term outcomes; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "MRI-first targeted pathway",
      "needed": "Initial testing/biopsy pathway and actual exposure",
      "role": "Required",
      "role_reason": "A production item distinguishing Initial testing/biopsy pathway and actual exposure to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Initial testing/biopsy pathway and actual exposure: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal on relationships between the initial pathway and subsequent exposure; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Standard TRUS and comparison specification",
      "needed": "Actual control pathway and subsequent care/treatment",
      "role": "Required",
      "role_reason": "A production item distinguishing Actual control pathway and subsequent care/treatment to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Actual control pathway and subsequent care/treatment: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal distinguishing pathways from attribution of subsequent outcomes; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Mortality equivalence and prespecified specification",
      "needed": "Prespecified mortality-equivalence margins and two-sided estimates/precision",
      "role": "Required",
      "role_reason": "A production item distinguishing Prespecified mortality-equivalence margins and two-sided estimates/precision to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Prespecified mortality-equivalence margins and two-sided estimates/precision: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a and M04 §4.6.3; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.4; Chamgap extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal distinguishing equivalence specifications from uncertainty; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Separate GG2 detection from mortality",
      "needed": "Detection-endpoint definitions/measurements and their relationship to mortality material",
      "role": "Required",
      "role_reason": "A production item distinguishing Detection-endpoint definitions/measurements and their relationship to mortality material to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Detection-endpoint definitions/measurements and their relationship to mortality material: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal on relationships between detection measures and long-term clinical outcomes; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "PRECISE original detection values",
      "needed": "Detection comparison, denominators, original estimates and scope",
      "role": "Required",
      "role_reason": "A production item distinguishing Detection comparison, denominators, original estimates and scope to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Detection comparison, denominators, original estimates and scope: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M04 §4.6.3 and M15 §15.3.1–15.3.3; separation of statuses is Chamgap’s own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal distinguishing estimates/specifications for different endpoints; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "MRI221·83/37%",
      "needed": "Actual MRI and biopsy-avoidance denominators/timing",
      "role": "Required",
      "role_reason": "A production item distinguishing Actual MRI and biopsy-avoidance denominators/timing to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Actual MRI and biopsy-avoidance denominators/timing: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal on relationships between test/biopsy exposure and long-term observation; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "453·226/227·225/227",
      "needed": "Separate randomized, observed, analyzed and mortality populations",
      "role": "Required",
      "role_reason": "A production item distinguishing Separate randomized, observed, analyzed and mortality populations to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Separate randomized, observed, analyzed and mortality populations: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A follow-up research proposal on analysis populations and omission assumptions; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Open-label design and mortality adjudication",
      "needed": "Allocation/concealment and role-specific test/pathology/mortality procedures",
      "role": "Required",
      "role_reason": "A production item distinguishing Allocation/concealment and role-specific test/pathology/mortality procedures to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Allocation/concealment and role-specific test/pathology/mortality procedures: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M08 §§8.1–8.2.3; Chamgap adaptation; M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M04 §§4.5–4.6 material collection/selection principles; access/reading separation and hyperlink rules are Chamgap-designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal on procedures and the bias scope of long-term outcomes; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "PRECISE 2-year follow-up",
      "needed": "Diagnosis/biopsy follow-up of the same trial and the mortality question",
      "role": "Required",
      "role_reason": "A production item distinguishing Diagnosis/biopsy follow-up of the same trial and the mortality question to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Diagnosis/biopsy follow-up of the same trial and the mortality question: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M03 §3.2.4 and M15 §15.3.1–15.3.3; question-specific result adaptation is Chamgap’s own design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M03 §3.2.4; Chamgap extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A time-point/endpoint-specific follow-up research proposal within the same trial; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "PRECISION500·28%",
      "needed": "Separate pathway trial and its relationship to selected mortality",
      "role": "Required",
      "role_reason": "A production item distinguishing Separate pathway trial and its relationship to selected mortality to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Separate pathway trial and its relationship to selected mortality: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/result links are a Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; design-specific adaptation is Chamgap’s own design; M03 §3.2.4; Chamgap extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal distinguishing pathway replication from mortality evidence; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Registration, prespecified endpoints and SAP",
      "needed": "Original registration questions/periods, plans/changes and correspondence with reports",
      "role": "Required",
      "role_reason": "A production item distinguishing Original registration questions/periods, plans/changes and correspondence with reports to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original registration questions/periods, plans/changes and correspondence with reports: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal linking prespecified plans to endpoint-specific reports; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Postdiagnosis treatment and concurrent exposure",
      "needed": "Arm-specific diagnosis, subsequent treatment/tests and mortality attribution",
      "role": "Required",
      "role_reason": "A production item distinguishing Arm-specific diagnosis, subsequent treatment/tests and mortality attribution to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Arm-specific diagnosis, subsequent treatment/tests and mortality attribution: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are Chamgap’s own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal on diagnostic pathways, subsequent exposure and mortality attribution; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "PRECISE funding and presentation resources",
      "needed": "Original funding/roles and the scope of presentation resources",
      "role": "Required",
      "role_reason": "A production item distinguishing Original funding/roles and the scope of presentation resources to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original funding/roles and the scope of presentation resources: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal distinguishing support roles and report relationships; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "PRECISION funding-identity gap",
      "needed": "Actual providers, roles and disclosures for the separate original trial",
      "role": "Required",
      "role_reason": "A production item distinguishing Actual providers, roles and disclosures for the separate original trial to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Actual providers, roles and disclosures for the separate original trial: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal distinguishing trial-specific support and role scopes; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Equipment, free support and COI",
      "needed": "Individual disclosures of equipment/products, analysis, writing/publication and author relationships",
      "role": "Required",
      "role_reason": "A production item distinguishing Individual disclosures of equipment/products, analysis, writing/publication and author relationships to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Individual disclosures of equipment/products, analysis, writing/publication and author relationships: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal distinguishing gaps in individual support and declarations; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N19",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Separate biopsy harms from mortality",
      "needed": "Harm collection/denominators versus long-term mortality endpoints",
      "role": "Supplementary",
      "role_reason": "A production item distinguishing Harm collection/denominators versus long-term mortality endpoints to connect the selected question’s needed material with current material.",
      "application_exception": "Supplement safety-evidence gaps for the selected subclaim. Do not judge safety from detection, other measure/symptom outcomes or parent safety wording, or generate harm incidence or new usage instructions.",
      "criterion": "Harm collection/denominators versus long-term mortality endpoints: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal distinguishing biopsy burden from long-term mortality/harms; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Trials/reports, independence and summation",
      "needed": "Original report–trial–population–endpoint relationships",
      "role": "Required",
      "role_reason": "A production item distinguishing Original report–trial–population–endpoint relationships to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original report–trial–population–endpoint relationships: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal distinguishing the same material from separate clinical evidence; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Other biopsy compositions and generalization",
      "needed": "Biopsy composition after positive MRI and outcomes beyond original populations/periods",
      "role": "Required",
      "role_reason": "A production item distinguishing Biopsy composition after positive MRI and outcomes beyond original populations/periods to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Biopsy composition after positive MRI and outcomes beyond original populations/periods: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M03 §3.2.4; custom extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal distinguishing the selected question from other conditions; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Original axes, Korean/English text, dates and corrections",
      "needed": "Distinguish subclaim/parent values, dates/corrections and history",
      "role": "Required",
      "role_reason": "Distinguish Distinguish subclaim/parent values, dates/corrections and history to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Distinguish subclaim/parent values, dates/corrections and history requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal updating original-material changes and production versions; no new investigation, calculation or trial is performed in this conversion."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Summary read; external material unread",
      "needed": "Actual reading by material, bibliography/URLs and additional-material gaps",
      "role": "Required",
      "role_reason": "A production item distinguishing Actual reading by material, bibliography/URLs and additional-material gaps to connect the selected question’s needed material with current material.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Actual reading by material, bibliography/URLs and additional-material gaps: relevant original material and analysis scope must be provided with unverified matters distinguished. This conversion links preserved wording; existing content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "A research proposal for scope-specific updates based on actually acquired material; no new investigation, calculation or trial is performed in this conversion."
    }
  ]
}
