{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Alpha-Stim AID × Major depression at 16 weeks — Evidence checklist",
  "language": "en",
  "translation_date": "2026-10-11",
  "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": "Which original question and verdict are preserved?",
      "needed": "Separate the selected subclaim from the parent verdict, score and axes",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Separate the selected subclaim from the parent verdict, score and axes and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Separate the selected subclaim from the parent verdict, score and axes are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules 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": "If the text changes, update the selected question link and parent context separately. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Which major-depression population was actually studied?",
      "needed": "Diagnosis, age, severity, selection/exclusion and recruitment setting",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Diagnosis, age, severity, selection/exclusion and recruitment setting and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Diagnosis, age, severity, selection/exclusion and recruitment setting are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions 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": "If direct results for particular populations are provided, distinguish their applicable scope. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Which device model was tested, and is it equivalent to other CES devices?",
      "needed": "Identity of the AID model, waveform, electrodes and device configuration",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Identity of the AID model, waveform, electrodes and device configuration and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Identity of the AID model, waveform, electrodes and device configuration are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; direction markers and adaptation for diagnostic questions are our own design; M04 §4.6.1–4.6.2, M15 §15.3.1; our 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": "Link different device reports by model and indication. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "How do study exposure and the assessment time differ?",
      "needed": "Study-intervention duration, exposure records and endpoint time",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Study-intervention duration, exposure records and endpoint time and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Study-intervention duration, exposure records and endpoint time are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; direction markers and adaptation for diagnostic questions are our own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is our own design; M03 §3.2.3, M08 §8.2.2–8.2.3; our 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": "Track actual study exposure and observation times separately. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What actually differed between active and sham devices?",
      "needed": "Active/sham configuration, sensation, concomitant treatment and comparison direction",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Active/sham configuration, sensation, concomitant treatment and comparison direction and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Active/sham configuration, sensation, concomitant treatment and comparison direction are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; 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": "If comparison details are obtained, distinguish added device contributions from accompanying changes. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "How are randomization and concealment recorded?",
      "needed": "Allocation method, concealment and baseline balance",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Allocation method, concealment and baseline balance and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Allocation method, concealment and baseline balance are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M08 §8.1–8.2.3; own application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our 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": "If methods material is provided, link allocation information relevant to the selected outcome. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Who was masked, and is masking success known?",
      "needed": "Participant, assessor and analyst masking and measurement procedures",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Participant, assessor and analyst masking and measurement procedures and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Participant, assessor and analyst masking and measurement procedures are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "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": "Record unresolved masking information separately from actual measurement limitations. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What outcome does 16-week GRID-HDRS-17 represent?",
      "needed": "Scale definition, units, direction, assessment method and time",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Scale definition, units, direction, assessment method and time and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Scale definition, units, direction, assessment method and time are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our 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": "Attribute definitions and analyses to their respective endpoints. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Are changes within each arm distinguished from between-arm differences?",
      "needed": "Separate arm-specific changes from the comparative estimate",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Separate arm-specific changes from the comparative estimate and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Separate arm-specific changes from the comparative estimate are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our 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": "Preserve within-arm improvement separately from the active-minus-sham effect. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What are the adjusted between-arm estimate, CI and P value?",
      "needed": "Comparison direction, adjustment model, denominator and original estimate",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Comparison direction, adjustment model, denominator and original estimate and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Comparison direction, adjustment model, denominator and original estimate are required, with unresolved items distinguished. This record links preserved wording; review of the existing content 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": "Link the original estimate and interval to their analysis. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "How are the prespecified 3-point threshold and original interpretation preserved?",
      "needed": "Important-difference criterion, timing of its specification and interpretation scope",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Important-difference criterion, timing of its specification and interpretation scope and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Important-difference criterion, timing of its specification and interpretation scope are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; 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": "Distinguish the prespecified importance criterion from its relationship to newly supplied analyses. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are allocation, 16-week observation and missingness distinguished?",
      "needed": "Allocation and observation denominators, missingness by arm and reasons",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Allocation and observation denominators, missingness by arm and reasons and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Allocation and observation denominators, missingness by arm and reasons are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations 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": "Link allocation and observation denominators to each outcome. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Does the ITT description adequately explain the actual analysis?",
      "needed": "Effect of interest, missing-data handling, model and sensitivity analyses",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Effect of interest, missing-data handling, model and sensitivity analyses and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Effect of interest, missing-data handling, model and sensitivity analyses are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.",
      "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": "Distinguish an analysis of observed participants from estimation of the effect of assignment. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Were endpoints, analyses and times compared with the plans?",
      "needed": "Registration, protocol and SAP alongside reported outcomes",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Registration, protocol and SAP alongside reported outcomes and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Registration, protocol and SAP alongside reported outcomes are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules 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": "If planning material is provided, record changes to endpoints, analyses and times separately. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are concomitant treatment, adherence and treatment changes known by arm?",
      "needed": "Arm-specific antidepressant treatment, counselling, adherence and rescue-treatment records",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Arm-specific antidepressant treatment, counselling, adherence and rescue-treatment records and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Arm-specific antidepressant treatment, counselling, adherence and rescue-treatment records are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation",
      "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": "Link material that distinguishes common treatment from added device contributions. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N16",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "How are safety review and early stopping recorded?",
      "needed": "Original description of review structure, stopping boundaries and completed follow-up",
      "role": "Supplementary",
      "role_reason": "Production condition for distinguishing Original description of review structure, stopping boundaries and completed follow-up and linking required and currently available materials for the selected question.",
      "application_exception": "Supplement safety-information gaps for the selected subclaim. Depressive-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.",
      "criterion": "Original materials and the applicable analytical scope for Original description of review structure, stopping boundaries and completed follow-up are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; our own application; M19 §19.1.2–19.2.4; our own application; M19 §19.1.2–19.2.4, M04 §4.6.3; our 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": "Record advance plans separately from actual stopping. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "What was the actual scope of NIHR support?",
      "needed": "Funding providers, supported items and roles",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Funding providers, supported items and roles and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Funding providers, supported items and roles are required, with unresolved items distinguished. This record links preserved wording; review of the existing content 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": "Distinguish support sources, roles and product support. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Which costs and devices did EPI provide?",
      "needed": "Manufacturer cash/cost support, product provision and scope of influence",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Manufacturer cash/cost support, product provision and scope of influence and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Manufacturer cash/cost support, product provision and scope of influence are required, with unresolved items distinguished. This record links preserved wording; review of the existing content 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": "Support alone does not justify excluding the result or certifying independence. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Which roles does the no-involvement declaration cover?",
      "needed": "Role disclosures for design, collection, analysis, interpretation and writing",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Role disclosures for design, collection, analysis, interpretation and writing and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Role disclosures for design, collection, analysis, interpretation and writing are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "Chamgap’s own independence and attribution conditions. The official methodology sections used in this pilot do not guarantee every detail of these items; M08 Table 8.2.a, M04 §4.6.3; our 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": "Record declared non-involvement separately from the actual level of verification. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are author employment, patents and analysis/publication support known?",
      "needed": "Author affiliations, COI, external analysis and manuscript/publication support",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Author affiliations, COI, external analysis and manuscript/publication support and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Author affiliations, COI, external analysis and manuscript/publication support are required, with unresolved items distinguished. This record links preserved wording; review of the existing content 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": "Link supplied disclosures item by item. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Does the 115-participant trial address the same AID question at 16 weeks?",
      "needed": "Agreements and differences in device, population, duration, scale and comparison",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Agreements and differences in device, population, duration, scale and comparison and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Agreements and differences in device, population, duration, scale and comparison are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2, M15 §15.3.1; our own application; M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; direction markers and adaptation for diagnostic questions are our own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is our 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": "Record comparison specifications separately by device, population and assessment time. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Were registration and funding for the Barclay trial verified?",
      "needed": "Actual registration identifier, support and COI",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Actual registration identifier, support and COI and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Actual registration identifier, support and COI are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract 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": "If an actual identifier or disclosure is provided, distinguish it from the original wording. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "What context does the 30-participant treatment-resistant-depression trial provide?",
      "needed": "Population, device, duration, endpoint, denominator and quantitative results",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Population, device, duration, endpoint, denominator and quantitative results and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Population, device, duration, endpoint, denominator and quantitative results are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2, M15 §15.3.1; our own application; M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; direction markers and adaptation for diagnostic questions are our own design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our 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": "Preserve the conditions of reports involving other populations or devices. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are registration and support for the 30-participant trial known?",
      "needed": "Registration identifier, support, product provision and COI",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Registration identifier, support, product provision and COI and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Registration identifier, support, product provision and COI are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract 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": "Record the actual status and identity of material obtained. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are conflicting findings and the original replication limits preserved?",
      "needed": "Family-specific conditions, positive/null findings and original replication limits",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Family-specific conditions, positive/null findings and original replication limits and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Family-specific conditions, positive/null findings and original replication limits are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is our own design; M04 §4.6.1–4.6.2, M15 §15.3.1; our own application; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome linkage is our 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": "Distinguish direct replication of the same question within the scope of newly supplied material. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "How are duplicate reports, trials and participants handled?",
      "needed": "Links from citations to trial families, outcomes and denominators",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Links from citations to trial families, outcomes and denominators and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Links from citations to trial families, outcomes and denominators are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 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": "Link citation, trial, population and time relationships separately. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N27",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What are the original adverse-event frequencies and their scope?",
      "needed": "Event definitions, people/events by arm, period and collection method",
      "role": "Supplementary",
      "role_reason": "Production condition for distinguishing Event definitions, people/events by arm, period and collection method and linking required and currently available materials for the selected question.",
      "application_exception": "Supplement safety-information gaps for the selected subclaim. Depressive-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.",
      "criterion": "Original materials and the applicable analytical scope for Event definitions, people/events by arm, period and collection method are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; our own application; M19 §19.1.2–19.2.4; detailed distinctions are our own design; M19 §19.2.2–19.2.4, M03 §3.2.3; our own application; M19 §19.1.2–19.2.4; our 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": "Record efficacy and harm denominators, periods and observations separately. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N28",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What is recorded about serious events and causal attribution?",
      "needed": "Event identity, timing, concurrent exposure and attribution basis",
      "role": "Supplementary",
      "role_reason": "Production condition for distinguishing Event identity, timing, concurrent exposure and attribution basis and linking required and currently available materials for the selected question.",
      "application_exception": "Supplement safety-information gaps for the selected subclaim. Depressive-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.",
      "criterion": "Original materials and the applicable analytical scope for Event identity, timing, concurrent exposure and attribution basis are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool",
      "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": "Distinguish event reporting from the material actually supporting relatedness assessment. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N29",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Are 16-week findings extended to other durations, indications or overall safety?",
      "needed": "Direct evidence for long-term outcomes, vulnerable groups and other devices/indications",
      "role": "Supplementary",
      "role_reason": "Production condition for distinguishing Direct evidence for long-term outcomes, vulnerable groups and other devices/indications and linking required and currently available materials for the selected question.",
      "application_exception": "Supplement safety-information gaps for the selected subclaim. Depressive-symptom results or parent safety wording do not establish safety, harm incidence or new device-use instructions.",
      "criterion": "Original materials and the applicable analytical scope for Direct evidence for long-term outcomes, vulnerable groups and other devices/indications are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap design; M03 §3.2.4; Chamgap extrapolation boundary; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation",
      "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": "Separate the selected question from extended questions. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "What history do dates, Korean/English text, empty corrections and cross-checking represent?",
      "needed": "Historical verdict date, language-specific wording, correction history and actual current actions",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Historical verdict date, language-specific wording, correction history and actual current actions and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Historical verdict date, language-specific wording, correction history and actual current actions are required, with unresolved items distinguished. This record links preserved wording; review of the existing content remains incomplete.",
      "basis": "M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our 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": "Distinguish original records, change events and production versions. Proposed; no new investigation, calculation or trial was performed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Which materials were actually read, and which links were only preserved?",
      "needed": "Separate access status for summaries, papers, registrations, protocols, SAP and funding/COI",
      "role": "Required",
      "role_reason": "Production condition for distinguishing Separate access status for summaries, papers, registrations, protocols, SAP and funding/COI and linking required and currently available materials for the selected question.",
      "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 materials and the applicable analytical scope for Separate access status for summaries, papers, registrations, protocols, SAP and funding/COI are required, with unresolved items distinguished. This record links preserved wording; review of the existing content 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": "Link user-supplied material by type and reading level. Proposed; no new investigation, calculation or trial was performed."
    }
  ]
}