{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Metformin × birthweight z score: evidence checklist for pregnancy with overweight or obesity and no diabetes",
  "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy",
      "question": "Is the selected z-score claim and subclaim verdict separate from the parent context?",
      "needed": "Separate records of subclaim wording, grade and note, and the parent verdict",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of subclaim wording, grade and note, and the parent verdict",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "If additional material is supplied, link material for the subclaim question and the parent context separately."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "What defines the population of pregnant women with overweight or obesity and no diabetes?",
      "needed": "Diabetes status, obesity, pregnancy timing, recruitment criteria and population-specific denominators",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Diabetes status, obesity, pregnancy timing, recruitment criteria and population-specific denominators",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link original trial-specific eligibility, baseline characteristics and population denominators."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "Is EMPOWaR research exposure distinguished from exposure in the other trials?",
      "needed": "Trial-specific original records of ingredient, formulation, research dose, start time and duration",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Trial-specific original records of ingredient, formulation, research dose, start time and duration",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link research exposure recorded in each trial’s original protocol and actual exposure material."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Were placebo and accompanying care, including dietary and lifestyle advice, the same conditions?",
      "needed": "Records of each arm’s placebo, common accompanying care, contact and additional treatment",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Records of each arm’s placebo, common accompanying care, contact and additional treatment",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Preserve original trial-specific comparators and common and differing accompanying care."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "What are the standardized definition and measurement timing of birthweight z score?",
      "needed": "Birth measurement, gestational age, parity and sex standardization methods and units",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Birth measurement, gestational age, parity and sex standardization methods and units",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain the original endpoint definition, standardization rules and birthweight measurement methods."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "Are EMPOWaR z-score means and the adjusted mean difference, CI and P preserved as recorded?",
      "needed": "Original arm means, adjusted effect, interval, test and analysis model",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Original arm means, adjusted effect, interval, test and analysis model",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link the original report’s adjustment model, variables, denominators and between-arm effect."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Are raw birthweight in grams and standardized z score the same outcome?",
      "needed": "Original units, arm order, distributions and effects for each measure",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Original units, arm order, distributions and effects for each measure",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link original table arm labels, raw gram values, standardized results and uncertainty separately."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "What are the EMPOWaR randomized and modified intention-to-treat denominators?",
      "needed": "Arm-specific randomized, analyzed and followed denominators and modified intention-to-treat exclusion criteria",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Arm-specific randomized, analyzed and followed denominators and modified intention-to-treat exclusion criteria",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain the modified intention-to-treat definition, arm-specific exclusions and missingness reasons, and outcome-specific analysis denominators."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "To which trial do the original allocation concealment and masking records apply?",
      "needed": "Trial-specific allocation, concealment and participant, caregiver and study-personnel masking material",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Trial-specific allocation, concealment and participant, caregiver and study-personnel masking material",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain each trial’s original methods and allocation, measurement and analysis procedures separately."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Are prespecified primary outcomes distinguished from access to registration, protocol and SAP?",
      "needed": "Original z-score prespecification, registration, changes and analysis-plan material",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Original z-score prespecification, registration, changes and analysis-plan material",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "If original registration, protocol and SAP are supplied, link endpoint hierarchy and change history."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Are MOP z-score results and analysis denominators preserved separately?",
      "needed": "Original MOP population, denominators, endpoint definition, effect and interval material",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Original MOP population, denominators, endpoint definition, effect and interval material",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain original MOP denominators, arm labels, measurement definition, effect, CI and missing-data handling."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Are the MOP paper bibliography and registration URL different material types?",
      "needed": "Separate links for the paper, registration identifier and actual access",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Separate links for the paper, registration identifier and actual access",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "If the paper and original registration are supplied separately, link their individual access, endpoints and plans."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "Were the effects of the two z-score trials kept separate rather than converted into new figures?",
      "needed": "The alignment scope of trial-specific standardization, analysis, denominators and effects",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "The alignment scope of trial-specific standardization, analysis, denominators and effects",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link trial-specific original definitions, denominators, adjustment and CI side by side while preserving their relationships."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Is the GRoW result for birthweight above 4000 g a direct z-score result?",
      "needed": "Direct distinction between a continuous standardized measure and a binary birth outcome",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Direct distinction between a continuous standardized measure and a binary birth outcome",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "If z-score material from the same trial is supplied, link its definition, hierarchy and denominator separately."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Are GRoW randomized and analyzed counts distinguished from pregnancy and birth analysis units?",
      "needed": "Pregnant-woman, infant and outcome-specific analysis denominators and exclusion criteria",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Pregnant-woman, infant and outcome-specific analysis denominators and exclusion criteria",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain outcome-specific analysis flow, arm denominators, follow-up and exclusion criteria."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "Are null results distinguished from exclusion of clinically meaningful benefit?",
      "needed": "A validated prespecified clinical-importance threshold and effect interval",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "A validated prespecified clinical-importance threshold and effect interval",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "If a prespecified validated threshold and original plan suitable for the population and endpoint are supplied, link them."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "Has birthweight z score been kept separate from later obesity itself?",
      "needed": "Direct evidence distinguishing a birth surrogate measure from long-term clinical outcomes",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Direct evidence distinguishing a birth surrogate measure from long-term clinical outcomes",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "A long-term clinical question requires its own outcome definition, follow-up, denominator and direct effect."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Are population and mechanism explanations distinguished from gestational-diabetes treatment effects?",
      "needed": "Direct boundaries between the selected indication context and other diseases or mechanisms",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Direct boundaries between the selected indication context and other diseases or mechanisms",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "If evidence for a new population is supplied, link it as a separate question even when the ingredient is the same."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy",
      "question": "Are shared relationships between reports, trials and related sheets maintained?",
      "needed": "Links between the same stored summary, bibliography, trial, population and endpoint",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Links between the same stored summary, bibliography, trial, population and endpoint",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link additional reports to the original trial identifiers without newly certifying independence."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Are EMPOWaR public funding, co-sponsorship and Merck in-kind supply distinguished?",
      "needed": "Separate original disclosure records for funding, sponsorship, products, authors and analysis roles",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Separate original disclosure records for funding, sponsorship, products, authors and analysis roles",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link original material separately for cash funding, free provision, affiliated authors and outside analysis roles."
    },
    {
      "item_id": "N21",
      "question_type": "Comparative efficacy",
      "question": "Is the original declaration of no manufacturer role separate from certification of independence?",
      "needed": "The actual original declaration on involvement in design, collection, analysis, interpretation and writing",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "The actual original declaration on involvement in design, collection, analysis, interpretation and writing",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain original disclosed roles, affiliations and data-access records and link them for content review."
    },
    {
      "item_id": "N22",
      "question_type": "Comparative efficacy",
      "question": "Is the original scope of MOP and GRoW funding and independent-replication wording preserved?",
      "needed": "Material-specific records of each trial’s funding, affiliations and research roles",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Material-specific records of each trial’s funding, affiliations and research roles",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain original material for each trial’s four company roles and public support separately."
    },
    {
      "item_id": "N23",
      "question_type": "Supplementary harm evidence",
      "question": "What actual information and denominators are available for gastrointestinal adverse effects and lower adherence?",
      "needed": "Trial-specific original arm tables of harm definitions, exposure, incidence, discontinuation and adherence",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Trial-specific original arm tables of harm definitions, exposure, incidence, discontinuation and adherence",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain trial-specific harm collection, arm events, exposure, discontinuation and adherence material."
    },
    {
      "item_id": "N24",
      "question_type": "Supplementary harm evidence",
      "question": "Does the fatal pregnancy-outcome composite distinguish component events, people and denominators?",
      "needed": "Definitions of miscarriage, pregnancy termination, stillbirth and neonatal death, with component-specific event denominators",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Definitions of miscarriage, pregnancy termination, stillbirth and neonatal death, with component-specific event denominators",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain original event definitions, component event tables, follow-up and denominators."
    },
    {
      "item_id": "N25",
      "question_type": "Supplementary harm evidence",
      "question": "Are a rare harm signal’s wide CI and confirmed harm distinguished?",
      "needed": "Direct material on rare-harm effects, intervals, tests and follow-up duration",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Direct material on rare-harm effects, intervals, tests and follow-up duration",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Adequate follow-up, original event-specific effects and rare-harm material are needed."
    },
    {
      "item_id": "N26",
      "question_type": "Supplementary harm evidence",
      "question": "Do gaps remain for other trials, long-term harm and post-birth follow-up?",
      "needed": "Trial-specific maternal, fetal and neonatal harm, follow-up and replication material",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Trial-specific maternal, fetal and neonatal harm, follow-up and replication material",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link direct maternal, infant and long-term follow-up harm material to the original trials."
    },
    {
      "item_id": "N27",
      "question_type": "Comparative efficacy",
      "question": "Is reading the stored summary distinguished from unread external papers, registration, protocol and SAP?",
      "needed": "Individual original links, material types and actual access records",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Individual original links, material types and actual access records",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link only original material obtained by the user with its material-specific actual access status."
    },
    {
      "item_id": "N28",
      "question_type": "Comparative efficacy",
      "question": "Are reference date, Korean/English text, corrections, original parent axes and empty values preserved?",
      "needed": "A complete copy of original languages, grades, axes, dates, corrections and empty values",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "A complete copy of original languages, grades, axes, dates, corrections and empty values",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "If new material or a user decision is supplied, preserve the original and reflect it as a separate change event."
    },
    {
      "item_id": "N29",
      "question_type": "Comparative efficacy",
      "question": "Are production status, content review and independent certification shown separately?",
      "needed": "Separate records of original candidate history and production status with incomplete content review",
      "role": "Supplementary",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of original candidate history and production status with incomplete content review",
      "basis": "Lower birthweight z score",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Proposal: Reflect only user-provided materials or decisions as separate events."
    }
  ]
}