{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Intravenous tranexamic acid × Improved 90-day functional status in spontaneous intracerebral hemorrhage",
  "language": "en",
  "translation_date": "2026-10-13",
  "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 90-day functional question and original values",
      "needed": "Distinguish the existing grade/note from the parent score/axes",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish the existing grade/note from the parent score/axes and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish the existing grade/note from the parent score/axes should be available, with unverified matters distinguishable. Preserved wording is connected here; 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": "Proposed follow-up research specifying the functional endpoint/timepoint; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Spontaneous intracerebral hemorrhage and population",
      "needed": "Actual scope of acuity/cause, eligibility and baseline risk",
      "role": "Required",
      "role_reason": "Applicability item distinguishing actual scope of acuity/cause, eligibility and baseline risk and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for actual scope of acuity/cause, eligibility and baseline risk should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population criteria are designed by CHAMGAP; M03 §3.2.1–3.2.4; Dose, duration and effect-modification details are designed by CHAMGAP; M03 §3.2.2–3.2.3; Reverse labels and test adaptations are designed by CHAMGAP",
      "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": "Proposed follow-up comparative research specifying the population/indication; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Intravenous 2 g within eight hours: research exposure",
      "needed": "Distinguish the original drug/route/timing from actual exposure",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish the original drug/route/timing from actual exposure and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish the original drug/route/timing from actual exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details 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": "Proposed follow-up research distinguishing route/timing and population specifications; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Identical packs and saline comparator",
      "needed": "Trial-drug/placebo preparation, support, sensory characteristics and contact specifications",
      "role": "Required",
      "role_reason": "Applicability item distinguishing trial-drug/placebo preparation, support, sensory characteristics and contact specifications and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for trial-drug/placebo preparation, support, sensory characteristics and contact specifications should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed; Chamgap’s own independence/attribution conditions. The official method sections used in this pilot do not warrant every detailed item; M08 Table 8.2.a, M03 §3.2.4; internal 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": "Proposed research disclosing the actual comparator and preparation/support roles; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Central allocation, minimization and concealment",
      "needed": "Historical allocation procedures and scope of actual original-material access",
      "role": "Required",
      "role_reason": "Applicability item distinguishing historical allocation procedures and scope of actual original-material access and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for historical allocation procedures and scope of actual original-material access should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; internal application; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications 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": "Proposed follow-up trials disclosing allocation procedures; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Masking and 90-day collection",
      "needed": "Masking scope for participants, assessment, clinical care and mRS collection",
      "role": "Required",
      "role_reason": "Applicability item distinguishing masking scope for participants, assessment, clinical care and mRS collection and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for masking scope for participants, assessment, clinical care and mRS collection should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; CHAMGAP adaptation; Material collection/selection principles in M04 §4.5–4.6; Separating access from reading and defining hyperlink behavior are designed by CHAMGAP",
      "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": "Proposed research specifying masking of measurement/adjudication; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "mRS 0–6, direction and distribution",
      "needed": "Scale definitions and distinction of distribution shift from means/thresholds",
      "role": "Required",
      "role_reason": "Applicability item distinguishing scale definitions and distinction of distribution shift from means/thresholds and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for scale definitions and distinction of distribution shift from means/thresholds should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4; internal 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": "Proposed follow-up research specifying differences between distributions, thresholds and importance; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "90 days and actual assessment window",
      "needed": "Distinguish the original timepoint from assessment/follow-up and other periods",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish the original timepoint from assessment/follow-up and other periods and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish the original timepoint from assessment/follow-up and other periods should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details 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": "Proposed follow-up research separating timepoints, function and survival outcomes; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "TICH-2 adjusted OR, CI and P",
      "needed": "Distinguish the original shift estimand from new effects/proportions",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish the original shift estimand from new effects/proportions and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish the original shift estimand from new effects/proportions should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations 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": "Proposed follow-up research disclosing the original estimand/precision; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "CI, meaningful benefits and the null result",
      "needed": "Scope of nonsignificance versus importance/equivalence",
      "role": "Required",
      "role_reason": "Applicability item distinguishing scope of nonsignificance versus importance/equivalence and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for scope of nonsignificance versus importance/equivalence should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; in-house application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is in-house design; M03 §3.2.4; in-house extension boundaries",
      "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": "Proposed research distinguishing effects/importance and question scope; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "2,325 participants, countries/hospitals and denominators",
      "needed": "Randomized population versus 90-day observation and multicenter/group units",
      "role": "Required",
      "role_reason": "Applicability item distinguishing randomized population versus 90-day observation and multicenter/group units and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for randomized population versus 90-day observation and multicenter/group units should be available, with unverified matters distinguishable. Preserved wording is connected here; 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": "Proposed follow-up research distinguishing recruitment, observation and analysis units; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "90-day 2,307/2,325 and 99.2%",
      "needed": "Distinguish the original availability rate from missingness/analysis populations",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish the original availability rate from missingness/analysis populations and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish the original availability rate from missingness/analysis populations should be available, with unverified matters distinguishable. Preserved wording is connected here; 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 design; 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": "Proposed research distinguishing availability/missingness from estimation populations; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "ITT and retaining allocated groups",
      "needed": "Historical analysis principles and current original-material access scope",
      "role": "Required",
      "role_reason": "Applicability item distinguishing historical analysis principles and current original-material access scope and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for historical analysis principles and current original-material access scope should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications 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": "Proposed research separately disclosing allocation, observation and actual-exposure analyses; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Registration, prespecified primary endpoint and combined identifiers",
      "needed": "Descriptions of prerecruitment registration/endpoint agreement versus full plans",
      "role": "Required",
      "role_reason": "Applicability item distinguishing descriptions of prerecruitment registration/endpoint agreement versus full plans and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for descriptions of prerecruitment registration/endpoint agreement versus full plans should be available, with unverified matters distinguishable. Preserved wording is connected here; 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": "Proposed research publicly linking prespecified plans with actual analyses; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Early secondary hematoma/death outcomes",
      "needed": "Hierarchy of 24-hour imaging, seven-day death and 90-day primary function",
      "role": "Required",
      "role_reason": "Applicability item distinguishing hierarchy of 24-hour imaging, seven-day death and 90-day primary function and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for hierarchy of 24-hour imaging, seven-day death and 90-day primary function should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M03 §3.2.4; internal extension boundary; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is 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": "Proposed research distinguishing primary function from early death/imaging outcomes; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Death/dependence sensitivity analysis",
      "needed": "Distinguish distribution shift from other definitions/sensitivity analyses",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish distribution shift from other definitions/sensitivity analyses and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish distribution shift from other definitions/sensitivity analyses should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own 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": "Proposed research separately reporting the primary distribution and sensitivity/threshold results; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "IPD meta-analysis: poor function and OR",
      "needed": "Distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish meta-analysis functional definitions/estimands from the TICH-2 distribution should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own 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": "Proposed follow-up evidence synthesis distinguishing functional definitions/estimands; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Nine trials/3,194 and IPD from five/2,860",
      "needed": "Distinguish reported aggregates/individual data from unique participants/overlap",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish reported aggregates/individual data from unique participants/overlap and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish reported aggregates/individual data from unique participants/overlap should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are internally applied; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M08 §8.2.2, M15 §15.3.1; internal 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": "Proposed research separately disclosing inclusion, acquisition, overlap and denominators; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Meta-analysis early death and imaging",
      "needed": "Separate meta-analysis results for 90-day function versus seven-day death/hematoma",
      "role": "Required",
      "role_reason": "Applicability item distinguishing separate meta-analysis results for 90-day function versus seven-day death/hematoma and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for separate meta-analysis results for 90-day function versus seven-day death/hematoma should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is 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": "Proposed research separately synthesizing early and long-term endpoints; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Meta-analysis/authors, original R1 and independence",
      "needed": "Synthesis reports versus unique trials, endpoint hierarchy and author relationships",
      "role": "Required",
      "role_reason": "Applicability item distinguishing synthesis reports versus unique trials, endpoint hierarchy and author relationships and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for synthesis reports versus unique trials, endpoint hierarchy and author relationships should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome connections are internally applied; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal 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": "Proposed follow-up independent comparative research with the same functional specifications; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Meta-analysis funding and registration: preserved records",
      "needed": "Distinguish original fields from funding/registration verification",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish original fields from funding/registration verification and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish original fields from funding/registration verification should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions. The official method sections used in this pilot do not warrant every detailed item; M04 §4.5–4.6 principles of material collection/selection; separation of access from reading and hyperlink specifications are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal 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": "Proposed research disclosing synthesis plans, support and assessment scope; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Concurrent treatment and timing/group analyses",
      "needed": "Distinguish the study drug from concurrent acute treatment/exposure",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish the study drug from concurrent acute treatment/exposure and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish the study drug from concurrent acute treatment/exposure should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation 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": "Proposed research distinguishing concurrent treatment from study exposure; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "NIHR/Swiss support and trial sponsor",
      "needed": "Support organizations and the University of Nottingham’s role",
      "role": "Required",
      "role_reason": "Applicability item distinguishing support organizations and the University of Nottingham’s role and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for support organizations and the University of Nottingham’s role should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "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": "Proposed research separately disclosing support and research roles; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Preparation expense and pharmaceutical/analysis/writing support",
      "needed": "Trial-expense preparation versus donated support/unreported items",
      "role": "Required",
      "role_reason": "Applicability item distinguishing trial-expense preparation versus donated support/unreported items and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for trial-expense preparation versus donated support/unreported items should be available, with unverified matters distinguishable. Preserved wording is connected here; 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": "Proposed research distinguishing support items from preparation/research roles; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N25",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Seizures, thrombosis and serious adverse events",
      "needed": "Distinguish separate safety endpoints/denominators from functional efficacy",
      "role": "Supplementary",
      "role_reason": "Applicability item distinguishing distinguish separate safety endpoints/denominators from functional efficacy and connecting materials needed for the selected question with current materials.",
      "application_exception": "Supplement the selected subclaim’s safety-material gaps. Functional-status/infection efficacy results or parent safety wording do not establish safety or create harms rates or new usage instructions.",
      "criterion": "Corresponding original materials and analysis scope for distinguish separate safety endpoints/denominators from functional efficacy should be available, with unverified matters distinguishable. Preserved wording is connected here; 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": "Proposed research separating harms from functional efficacy; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Other indications/periods and generalization",
      "needed": "Original spontaneous hemorrhage/route/timing versus separate effects",
      "role": "Required",
      "role_reason": "Applicability item distinguishing original spontaneous hemorrhage/route/timing versus separate effects and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for original spontaneous hemorrhage/route/timing versus separate effects should be available, with unverified matters distinguishable. Preserved wording is connected here; existing content review remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.2–3.2.3; reverse-direction markers and test adaptation are internally designed; M03 §3.2.4; internal 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": "Proposed research distinguishing directness across indications/periods; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Original axes, Korean/English text, dates and corrections",
      "needed": "Distinguish parent/subclaim values, verdict date/meta-analysis year and history",
      "role": "Required",
      "role_reason": "Applicability item distinguishing distinguish parent/subclaim values, verdict date/meta-analysis year and history and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for distinguish parent/subclaim values, verdict date/meta-analysis year and history should be available, with unverified matters distinguishable. Preserved wording is connected here; existing 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": "Proposed research distinguishing original values/history from the scope of update materials; no new search, calculation or trial was performed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Actual summary reading, links and gaps",
      "needed": "Preserved summary versus external trial/meta-analysis/registration/plan access",
      "role": "Required",
      "role_reason": "Applicability item distinguishing preserved summary versus external trial/meta-analysis/registration/plan access and connecting materials needed for the selected question with current materials.",
      "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": "Corresponding original materials and analysis scope for preserved summary versus external trial/meta-analysis/registration/plan access should be available, with unverified matters distinguishable. Preserved wording is connected here; 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": "Proposed research updating records with actual acquisition, timing and scope distinguished; no new search, calculation or trial was performed."
    }
  ]
}