{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "MVA85A booster × Added tuberculosis prevention after BCG — Evidence checklist",
  "language": "en",
  "translation_date": "2026-10-10",
  "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": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.",
    "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": "User review pending.",
    "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": "Efficacy comparison and presentation of stored material",
      "question": "What are the subclaim and parent values for added protection after BCG?",
      "needed": "Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of 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": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Subclaim D grade and note, absent score/status/axes, and distinction from parent D34/axes as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Were participants studied before BCG vaccination or as already vaccinated infants?",
      "needed": "Healthy, already vaccinated infants and the actual selection, age and setting boundaries",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Healthy, already vaccinated infants and the actual selection, age and setting boundaries and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Healthy, already vaccinated infants and the actual selection, age and setting boundaries must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Healthy, already vaccinated infants and the actual selection, age and setting boundaries as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are added MVA85A and the effect of BCG itself the same question?",
      "needed": "BCG in both groups, the added candidate effect and comparison with placebo",
      "role": "Required",
      "role_reason": "An item prepared to distinguish BCG in both groups, the added candidate effect and comparison with placebo and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for BCG in both groups, the added candidate effect and comparison with placebo must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of 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": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking BCG in both groups, the added candidate effect and comparison with placebo as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What research condition defines MVA85A?",
      "needed": "Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Antigen 85A, the modified vaccinia Ankara vector, and exposure/product standardization as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What is known about allocation and assessment in the double-blind phase 2b design?",
      "needed": "Randomization/placebo, allocation concealment and tuberculosis case adjudication",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Randomization/placebo, allocation concealment and tuberculosis case adjudication and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Randomization/placebo, allocation concealment and tuberculosis case adjudication must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Randomization/placebo, allocation concealment and tuberculosis case adjudication as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do 2797 participants differ from tuberculosis denominators 1399/1395?",
      "needed": "Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content 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": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Original randomized count, tuberculosis analysis/observed denominators, and losses/exclusions as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How were incident tuberculosis cases defined and adjudicated?",
      "needed": "Incident TB, clinical/test/severity definitions and case collection criteria",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Incident TB, clinical/test/severity definitions and case collection criteria and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Incident TB, clinical/test/severity definitions and case collection criteria must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation to each question is internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Incident TB, clinical/test/severity definitions and case collection criteria as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are tuberculosis disease, infection and immune response the same outcome?",
      "needed": "Separate definitions/denominators for disease and infection/immune surrogate markers",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Separate definitions/denominators for disease and infection/immune surrogate markers and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Separate definitions/denominators for disease and infection/immune surrogate markers must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Separate definitions/denominators for disease and infection/immune surrogate markers as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does up to 37 months mean the same observation period for everyone?",
      "needed": "Maximum follow-up, duration/censoring and first/recurrent event units",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Maximum follow-up, duration/censoring and first/recurrent event units and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Maximum follow-up, duration/censoring and first/recurrent event units must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Maximum follow-up, duration/censoring and first/recurrent event units as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Which groups do the tuberculosis fractions, proportions and absolute difference describe?",
      "needed": "MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p",
      "role": "Required",
      "role_reason": "An item prepared to distinguish MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking MVA 32/1399 (2.3%), control 39/1395 (2.8%) and −.5%p as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What possibilities remain within the interval around vaccine efficacy 17.3%?",
      "needed": "Original 17.3%, 95% CI −31.9~48.2, model and comparison direction",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Original 17.3%, 95% CI −31.9~48.2, model and comparison direction and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Original 17.3%, 95% CI −31.9~48.2, model and comparison direction must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Original 17.3%, 95% CI −31.9~48.2, model and comparison direction as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are the finding of no significant benefit or candidate success and the wide interval preserved together?",
      "needed": "Original D34/E0, no significant benefit and precision of the original CI",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Original D34/E0, no significant benefit and precision of the original CI and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Original D34/E0, no significant benefit and precision of the original CI must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M04 §4.6.3 and M15 §15.3.1–15.3.3; Status separation is Chamgap design; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Original D34/E0, no significant benefit and precision of the original CI as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What prespecified analysis/endpoint specification applies to tuberculosis disease?",
      "needed": "Original main disease time point, prespecified hierarchy, infection/safety and multiplicity",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Original main disease time point, prespecified hierarchy, infection/safety and multiplicity and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Original main disease time point, prespecified hierarchy, infection/safety and multiplicity must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Original main disease time point, prespecified hierarchy, infection/safety and multiplicity as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do actual exposure, BCG/concomitant interventions and follow-up measures relate to the added effect?",
      "needed": "Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Allocation versus actual vaccination/crossover, accompanying exposures, and collection/losses as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are one trial, the parent/this sheet and different outcomes kept from becoming new independent counts?",
      "needed": "The same MVA85A020 trial, shared denominators/durations and added-effect question",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The same MVA85A020 trial, shared denominators/durations and added-effect question and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for The same MVA85A020 trial, shared denominators/durations and added-effect question must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of 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": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The same MVA85A020 trial, shared denominators/durations and added-effect question as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is the 1245 first BCG vaccination manuscript a direct trial of an added booster?",
      "needed": "Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.1; detailed population conditions are internally designed",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Boundary between the BCG B64 reference in unvaccinated children and the added effect in already vaccinated infants as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is the 2743 shortened pulmonary tuberculosis treatment reference a preventive vaccine result?",
      "needed": "Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are internally designed",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Separation of treatment C56 for established drug-susceptible pulmonary tuberculosis from prevention as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What are the Aeras/Wellcome/OETC relationships and commercial rights?",
      "needed": "Nonprofit/development consortium, Oxford/Emergent relationships and actual roles",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Nonprofit/development consortium, Oxford/Emergent relationships and actual roles and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Nonprofit/development consortium, Oxford/Emergent relationships and actual roles must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of 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": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Nonprofit/development consortium, Oxford/Emergent relationships and actual roles as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Do development rights and mixed funding verify all COI and product support?",
      "needed": "Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of 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": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Separate information on original rights/funding and free vaccines, employees/COI and decision-making authority as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N20",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Were the registration number and prespecified disease/infection plans actually read?",
      "needed": "NCT00953927 record, plans/change history, missing data and hierarchy",
      "role": "Required",
      "role_reason": "An item prepared to distinguish NCT00953927 record, plans/change history, missing data and hierarchy and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for NCT00953927 record, plans/change history, missing data and hierarchy must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of 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; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking NCT00953927 record, plans/change history, missing data and hierarchy as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N21",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What denominators and periods apply to local, systemic and serious adverse events?",
      "needed": "Distinct safety specifications for original 89/45%, 80/76% and 18/18%",
      "role": "Supplementary",
      "role_reason": "An item prepared to distinguish Distinct safety specifications for original 89/45%, 80/76% and 18/18% and connect the selected question's required materials with the available materials.",
      "application_exception": "Addresses gaps in harm information for the selected recurrence/additional tuberculosis prevention question. Original efficacy, recurrence or safety wording is not used to judge overall safety or generate harm rates or guidance on antibiotic or vaccine selection, use or suitability.",
      "criterion": "Relevant original materials and the scope of analysis for Distinct safety specifications for original 89/45%, 80/76% and 18/18% must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Distinct safety specifications for original 89/45%, 80/76% and 18/18% as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N22",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Does absence of related serious events mean zero risk or a vaccination recommendation?",
      "needed": "Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms",
      "role": "Supplementary",
      "role_reason": "An item prepared to distinguish Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms and connect the selected question's required materials with the available materials.",
      "application_exception": "Addresses gaps in harm information for the selected recurrence/additional tuberculosis prevention question. Original efficacy, recurrence or safety wording is not used to judge overall safety or generate harm rates or guidance on antibiotic or vaccine selection, use or suitability.",
      "criterion": "Relevant original materials and the scope of analysis for Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; detailed distinctions are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; Chamgap's own interpretation boundary. Refers to M19 principles; no formal causality tool was applied.",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Separation of original relatedness judgments from all serious events and long-term/vulnerable-population harms as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can the result be generalized to BCG policy, other candidates/populations, prevention or treatment?",
      "needed": "Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are Chamgap's own design; M03 §3.2.1; detailed population conditions are Chamgap's own design; M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap's own design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Boundary of the MVA candidate in already vaccinated infants versus other vaccines, periods and diseases as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What was actually read of the stored summary, external papers/manuscripts and links?",
      "needed": "Full stored summary, PMID23391465/two reference URLs and unread external sources",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Full stored summary, PMID23391465/two reference URLs and unread external sources and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Full stored summary, PMID23391465/two reference URLs and unread external sources must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of 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": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Full stored summary, PMID23391465/two reference URLs and unread external sources as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N25",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are existing Korean/English manuscripts, D34/axes, dates and empty values preserved?",
      "needed": "Subclaim D, parent D34, 2026-08-26, false/empty values and correction history",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Subclaim D, parent D34, 2026-08-26, false/empty values and correction history and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Subclaim D, parent D34, 2026-08-26, false/empty values and correction history must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of 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": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Subclaim D, parent D34, 2026-08-26, false/empty values and correction history as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N26",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are condition preservation/application, case preparation and content review distinguished?",
      "needed": "Records of condition preservation, freezing/application, case preparation and incomplete content review",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Records of condition preservation, freezing/application, case preparation and incomplete content review and connect the selected question's required materials with the available 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": "Relevant original materials and the scope of analysis for Records of condition preservation, freezing/application, case preparation and incomplete content review must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of 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": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Records of condition preservation, freezing/application, case preparation and incomplete content review as a separate item; no new research, calculation or testing is performed in this preparation."
    }
  ]
}