「regulatory」の検索結果

Implements missing-data sensitivity analyses for confirmatory clinical trials including MMRM under MAR (with Kenward-Roger correction), reference-based multiple imputation (J2R, CR, CIR, LMCF per Carpenter-Roger 2013), Permutt delta-adjustment / tipping-point analysis, pattern-mixture identifying restrictions (CCMV, NCMV, ACMV), and the Cro vs Bartlett variance debate. Use when handling missing primary or secondary endpoint data in regulatory submissions following NRC 2010 and ICH E9(R1).

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Reads, validates, and prepares CDISC SDTM and ADaM clinical trial data for analysis. Covers SDTM domain joins (DM, AE, EX, VS, LB, DS), ADaM architecture (ADSL, BDS, OCCDS, ADTTE) with traceability, treatment-emergent AE conventions, baseline derivation, SUPPQUAL/NSV handling, Define-XML 2.1, and Pinnacle 21 / CORE validation. Use when working with clinical trial datasets in CDISC SDTM/ADaM format, preparing analysis-ready data, or validating for regulatory submission.

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Detect allele-specific chromatin accessibility from ATAC-seq using WASP, GATK ASEReadCounter, or RASQUAL. Use when mapping cis-regulatory genetic variants from heterozygous SNPs, separating cis from trans regulation, building chromatin QTL (caQTL) maps, validating GWAS variant function with allelic imbalance, or detecting reference allele mapping bias before downstream analysis.

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Draft a Business Requirements Document (BRD) for cross-functional or stakeholder-heavy work that needs more structure than an intake. Use after `/intake` when the request spans multiple systems/teams, carries regulatory weight, or needs formal sign-off. Output lives at `docs/brd/<slug>.md`.

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Any live-web task via the Firecrawl CLI — including ordinary web research: searching the web, reading or extracting pages, gathering sources, discovering site URLs, bulk extraction, downloading a site, change alerts, or pages needing clicks/login — web only; local files route to firecrawl-parse. For US legal or regulatory questions use gov; for papers use firecrawl-research-index; for library, API, error, or bug questions use firecrawl-developer-index.

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Expert-level medical device design covering regulatory pathways, design controls, biocompatibility, sterilization, risk management, and verification and validation.

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Expert-level environmental remediation covering site characterization, risk assessment, remediation technology selection, in-situ and ex-situ treatment, and regulatory closure.

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Expert-level biomaterials covering biocompatibility, metals, ceramics, and polymers for medical implants, surface modification, host response, and regulatory considerations.

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Use when sequencing market entry — geo / segment / vertical, beachhead selection, regulatory-delta. Triggers on 'should we enter market X', 'which segment first'.

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Knowledge base from the NASA Probabilistic Risk Assessment Procedures Guide (NASA/SP-2011-3421, 2nd ed.). Use for quantitative PRA of aerospace and safety-critical systems: the risk triplet and scenario logic stack (MLD, ESD, event trees, fault trees, minimal cut sets), Bayesian data collection and parameter estimation, aleatory/epistemic uncertainty modeling and common-cause failure (Alpha Factor, beta-factor, CCBE), human reliability analysis (THERP, CREAM, NARA, SPAR-H), context-based software risk (CSRM), physics-based and structural/phenomenological models (stress-strength, limit states, FORM/SORM, NASGRO, range safety), uncertainty propagation and importance measures (F-V, RAW, Birnbaum, DIM), and launch-abort modeling with worked PRA examples. This is the QUANTITATIVE engine beneath NASA's risk doctrine — for the qualitative RIDM/CRM decision framework use the nasa-risk pack. Thin on programme management, organisational risk governance, and non-aerospace regulatory contexts; aerospace-focused and anchored to the 2011 second edition.

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Knowledge base from the FAA System Safety Handbook (Dec 30, 2000). Use for system safety as a specialty within systems engineering: the five-step safety risk management process (mandated by FAA Order 8040.4 and the AMS), the severity-by-likelihood risk matrix and acceptance bands, the Safety Order of Precedence, system-description models (5M, SHEL(L)), the hazard-analysis activities (PHL/PHA/RHA/SSHA/SHA/O&SHA/HHA), integrated system hazard analysis, the analysis techniques (FTA, FMEA/FMECA, Fault Hazard, Common Cause, Sneak Circuit, Energy Trace), closed-loop hazard tracking (Safety Action Record), and the specialty domains the handbook covers — acquisition-lifecycle safety and contracting (OSA/CSA/SSPP/ISSPP), software safety (control-capability ranking, SHCM, DO-178B), test & evaluation safety, facilities safety, commercial launch safety (AST licensing, expected casualty, MPL/DAMP), system safety training, and Operational Risk Management (ORM) with human/organizational factors. Scope limits: this is a year-2000 FAA how-to; it predates the modern FAA/ICAO Safety Management System (SMS) and Just Culture regulatory frameworks, and many cited orders, advisory circulars, and launch-licensing rules have since been restructured. It is FAA/NAS-centric, leans on MIL-STD-882C, and does not define the SE life-cycle processes themselves (use nasa-npr-7123 / dau-se-guidebook) or reproduce third-party standard text (MIL-STD-882, DO-178B, ISO/IEC/IEEE).

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Knowledge base from the OUSD(R&E) guidebook Implementing a MOSA in DoD Programs (Feb 2025). Use for the Modular Open Systems Approach as a DoD acquisition + design discipline: the statutory/regulatory basis (10 U.S.C. 4401–4403, FY2017/FY2021 NDAA, DFARS), the five OUSD(R&E) pillars, the plan→modularize→identify→define→standardize interface lifecycle, technical levers (WBS/MIL-STD-881F taxonomy, standards profiling, API-first software, COTS/cybersecurity), MOSA assessment metrics and tools (PART/OAAT/KOSS/SEAM/MAUT), technology-change and DMSMS management, roadmaps, MOSA across the six AAF pathways, and contracting/IP/data-rights mechanics. SCOPE LIMITS: this is U.S. DoD weapon-system acquisition policy, not a general open-architecture or interface-standards reference — it names standards (FACE, OMS, DISR) without reproducing them, is light on detailed engineering of any specific standard, and does not cover the underlying SE processes (use dau-se-guidebook / nasa-npr-7123) or general systems-engineering theory (use sebok).

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Reviews a proposal, business case, deck or plan in character as a Chief Information Security Officer archetype and returns a DRAFT review with a verdict, findings cited to specific passages, security and compliance risks and the five interrogation questions a real CISO would ask. Use when the user asks to "run a CISO review", "pressure-test the security of this plan", "what would our CISO say about this" or "check the privacy and third-party risk". Do not use for contract, liability or regulatory-interpretation reviews, use general-counsel-reviewer instead. Drafts for human review; never approves, authorises or signs off.

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Reviews a proposal, business case, deck or plan in character as a Chief Data Officer archetype and returns a DRAFT review in the chat with a verdict, findings that cite the exact passage, data and AI governance risks, what would change the verdict and five interrogation questions. Use when the user asks to "run a CDO review", "pressure-test the data governance in this plan", "what would a CDO say about this", "check the metric definitions and data sources" or "prepare this for the data governance board". Do not use for security controls or third-party security risk, use ciso-reviewer instead; for contract, liability or regulatory terms, use general-counsel-reviewer. Drafts for human review; never approves, authorises or signs off.

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Reviews a proposal, business case, deck or vendor contract in character as a Head of Procurement archetype and returns a DRAFT review in the chat with a verdict, findings that cite the exact passage or clause, commercial risks, what would change the verdict and five interrogation questions. Use when the user asks to "review this from a procurement angle", "what would procurement say about this proposal", "pressure-test this vendor contract commercially", "find the holes before the sourcing committee" or "check the renewal terms like a Head of Procurement would". Do not use for liability, IP, regulatory or signing-authority questions, use general-counsel-reviewer instead; for whether the spend fits the budget, use cfo-reviewer; for vendor security, use ciso-reviewer. Drafts for human review; never approves, authorises or signs off.

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Use when working with Azure Policy Deep — azure Policy deep compliance and governance management. Covers policy definitions, initiatives, assignments, compliance evaluation, exemptions, remediation tasks, custom policies, and regulatory compliance. Use when managing Azure governance at scale, reviewing compliance states, creating custom policies, or troubleshooting policy evaluation results.

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Analyzes genetic variant effects on gene expression (RNA-seq), chromatin accessibility (DNASE), histone marks (ChIP), and transcription factors using the AlphaGenome API. Use when the user asks about non-coding variant effects, pathogenicity, clinical significance, disease associations, functional effects, gene expression changes, splicing disruption, or regulatory effects in promoters and enhancers. Also use for resolving biological terms to tissue/cell-type ontologies (UBERON/CL) or analyzing variants in chr:pos:ref>alt format.

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Use when asked to map, crosswalk, align, compare, or gap-analyze any two cybersecurity frameworks, control catalogs, or regulatory requirements using NIST IR 8477 Set-Theory Relationship Mapping (STRM). Triggers on terms like "map controls", "crosswalk", "framework alignment", "gap analysis", or producing a STRM CSV output file.

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Validates compliance, security, and GRC terminology in marketing copy. Enforces accurate claims, prevents common mistakes (e.g., calling SOC 2 a "certification"), and applies risk-first narrative framing for B2B SaaS audiences. Use when writing or reviewing any marketing content that references compliance frameworks, security standards, regulatory requirements, or audit processes. Also use when creating ads, landing pages, emails, case studies, or sales collateral for GRC/cybersecurity B2B SaaS products.

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Implements missing-data sensitivity analyses for confirmatory clinical trials including MMRM under MAR (with Kenward-Roger correction), reference-based multiple imputation (J2R, CR, CIR, LMCF per Carpenter-Roger 2013), Permutt delta-adjustment / tipping-point analysis, pattern-mixture identifying restrictions (CCMV, NCMV, ACMV), and the Cro vs Bartlett variance debate. Use when handling missing primary or secondary endpoint data in regulatory submissions following NRC 2010 and ICH E9(R1).

日本語の概要は準備中です。原文の説明を表示しています。

Reads, validates, and prepares CDISC SDTM and ADaM clinical trial data for analysis. Covers SDTM domain joins (DM, AE, EX, VS, LB, DS), ADaM architecture (ADSL, BDS, OCCDS, ADTTE) with traceability, treatment-emergent AE conventions, baseline derivation, SUPPQUAL/NSV handling, Define-XML 2.1, and Pinnacle 21 / CORE validation. Use when working with clinical trial datasets in CDISC SDTM/ADaM format, preparing analysis-ready data, or validating for regulatory submission.

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Performs subgroup and heterogeneous treatment effect (HTE) analyses for clinical trials. Covers Mantel-Haenszel pooling, Breslow-Day, interaction tests in regression, RERI for additive interaction, modern data-adaptive HTE methods (STEPP, SIDES, causal forests, X/R-learners), Bayesian shrinkage (Dixon-Simon, MAP, EXNEX), graphical multiplicity (Bretz-Maurer), and credibility frameworks (Sun BMJ, EMA 2019). Use when analyzing treatment effects across patient subgroups for regulatory submissions or precision-medicine claims.

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Strategic clinical trial design feasibility assessment. Analyzes 6 dimensions (endpoint, population, comparator, effect size, duration, regulatory pathway) using precedent trials and FDA guidance. Produces enrollment projections, endpoint recommendations, and approval-pathway analysis. Use for trial-protocol design, power/sample-size estimation, comparator selection, and FDA submission strategy. Driven by precedent-based reasoning rather than first-principles math.

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Prepares statistical reports for clinical trials following CONSORT 2025, SPIRIT 2025, ICH E9(R1) estimands, and FDA 2023 covariate adjustment guidance. Covers Table 1 generation, analysis populations (ITT/FAS/PP/Safety), the 5 ICH E9(R1) intercurrent-event strategies, MMRM under MAR (mmrm), reference-based MI (rbmi J2R/CR/CIR), Permutt tipping-point sensitivity, and Rubin's-rules vs frequentist variance debate. Use when preparing regulatory submissions, defining estimands, or implementing missing-data sensitivity analyses.

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