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臨床試験実施者キット

臨床試験の実施：プロトコル、SAP、症例数、同意、倫理審査、データマネジメント、CRF、DSMB、総括報告、医療経済評価、査読。

12 件のテンプレートを、使う順に 3 ステップで並べています。エディターで開いて記入し、PDF、DOCX、HTML に書き出せます。

ステップ 1

計画

  1. Clinical Trial Protocol Template (SPIRIT 2025)

    フル

    Randomised trial protocol following the 34 SPIRIT 2025 items: open science, PPI, interventions, harms, timeline, monitoring

    SPIRIT 2025; ICH E6(R3); Declaration of Helsinki 2024

  2. Statistical Analysis Plan Template (Statistics, Thesis or Project)

    フル

    Statistical analysis plan for a thesis or project: estimands, hypotheses, sample size, primary model, pre-set assumption fallbacks, missing data, multiplicity, sensitivity, deviations log

    ICH E9(R1) estimand framework (name); Gamble et al. (2017) SAP content; Holm (1979); Rubin (1987); Borm et al. (2007)

  3. Power Analysis and Sample Size Template (Statistics, R and Python)

    フル

    Power analysis and sample size worksheet: t-tests, proportions, ANOVA, correlation, regression, simulation power, sensitivity table and justification sentence

    Cohen (1988); Lakens (2022) sample size justification; Hoenig and Heisey (2001); pwr 1.3.0 and statsmodels 0.15.0

  4. Participant Information Sheet and Consent Form Template

    フル

    Research participant information sheet and consent form: key information, visits, risks, data protection, consent, ICH E6(R3) and 45 CFR 46.116 checklist

    ICH E6(R3) 2.8 (2025); 45 CFR 46.116; GDPR Art. 9

  5. Research Ethics Application Template (IRB, REC)

    フル

    IRB or REC application draft: lay summary, team, design, recruitment, vulnerability, risk table, consent and waiver, data protection, safety, registration, review route, Helsinki map

    Declaration of Helsinki (2024 revision); dated EU, UK, US examples
ステップ 2

試験の実施

  1. Data Management Plan (DMP) Template

    フル

    Funder-neutral DMP: data summary, documentation, storage, legal and ethics, FAIR sharing, other outputs, costs, annexes for NIH 2026, NSF, Horizon Europe, UKRI

    Science Europe DMP core requirements; FAIR; NIH 2026 DMS Plan format (NOT-OD-26-046); NSF PAPPG 24-1; Horizon Europe DMP template v1.1; UKRI

  2. Case Report Form (CRF) Specification Template

    標準

    Clinical trial CRF/eCRF spec: visit and form matrix, CDASH field tables (DM, AE, VS), codelists, edit checks, query states, site completion rules, traceability

    CDISC CDASHIG v2.3; ICH E6(R3)

  3. Data Monitoring Committee (DSMB) Charter Template

    標準

    DMC/DSMB charter: role, membership and independence, data flow and firewall, open and closed sessions, reports, stopping guidelines, recommendations, sign-off

    DAMOCLES charter (Lancet 2005); SPIRIT 2025 items 28a, 28b
ステップ 3

ドキュメント化

  1. Randomised Controlled Trial Report Template (CONSORT 2025)

    フル

    Randomised trial report following the 30 CONSORT 2025 items: open science, PPI, methods, flow diagram, results, harms

    CONSORT 2025

  2. Health Economic Evaluation Report Template (CHEERS 2022)

    フル

    Health economic evaluation report: decision problem, HEAP, perspective, horizon, discounting, costs, QALYs, model, ICER, NMB, PSA, equity, CHEERS map

    CHEERS 2022 (28 items; BMJ 2022;376:e067975)

  3. Research Paper Template (IMRaD)

    フル

    IMRaD paper: title page, structured abstract, methods, results with stats conventions, discussion, declarations, CRediT

    IMRaD; ICMJE Recommendations (reference); CONSORT 2025, SPIRIT 2025, STROBE, TARGET, STARD 2015, PRISMA 2020 (named)

  4. Response to Reviewers Letter Template

    標準

    Point-by-point reply to editor and reviewers: cover note, summary counts, quoted comments with responses and locations, change log, co-author plan, checklist

    Common editorial practice; COPE Core Practices