lev-os
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- ▌ Managing Investor Compliance Requests · lev-osCoordinates regulatory and compliance information requests from institutional LPs including FOIA, regulatory filings, and audit support. Use when responding to compliance requests, managing FOIA inquiries, or supporting LP audit processes.
- ▌ Managing Operating Partner Engagement · lev-osStructures operating partner involvement with portfolio company assignment, initiative tracking, and impact measurement. Use when coordinating operating partners, tracking operational initiatives, or measuring portfolio support impact.
- ▌ Managing Portfolio Company Governance · lev-osStructures board governance for portfolio companies with reporting cadence and strategic oversight documentation. Use when managing portfolio boards, structuring governance frameworks, or documenting board practices.
- ▌ Managing Privacy Compliance Financial · lev-osEvaluates data privacy practices against GLBA, CCPA, and state privacy requirements. Use when assessing financial privacy compliance, managing opt-out requirements, or documenting data practices.
- ▌ Managing Treasury Management Services · lev-osStructures treasury management product analysis with cash management, payment solutions, and fee optimization. Use when evaluating treasury services, analyzing cash management needs, or optimizing banking relationships.
- ▌ Modeling Counterparty Credit Exposure · lev-osCalculates potential future exposure and CVA with simulation-based approaches and netting agreement analysis. Use when modeling counterparty exposure, calculating CVA/DVA, or assessing counterparty risk.
- ▌ Modeling Interest Rate And Basis Risk · lev-osAnalyzes structural interest rate exposure with fixed/floating mismatch, basis risk, and cap/floor adequacy assessment. Use when modeling structural rate risk, analyzing basis risk, or evaluating interest rate hedging needs.
- ▌ Modeling Intraday Volatility Patterns · lev-osAnalyzes intraday volatility dynamics with open/close effects, lunch-time patterns, and event-driven volatility estimation. Use when modeling intraday volatility, timing order execution, or analyzing time-of-day effects.
- ▌ Modeling Portfolio Risk Decomposition · lev-osDecomposes portfolio risk with factor attribution, idiosyncratic risk, and marginal contribution to risk analysis. Use when decomposing portfolio risk, attributing risk sources, or analyzing factor risk contribution.
- ▌ Modeling Resource Depletion Economics · lev-osBuilds depletion models with production decline, reserve replacement economics, and terminal value analysis for finite-life assets. Use when modeling depletion, analyzing resource longevity, or evaluating reserve life economics.
- ▌ Modeling Scenario Planning Frameworks · lev-osBuilds corporate scenario planning models with macro assumption sets, strategic response options, and contingency plan development. Use when building scenario frameworks, planning strategic responses, or developing contingency strategies.
- ▌ Notice Of Annual Shareholders Meeting · lev-osDrafts a U.S. corporate annual shareholders meeting notice enforcing record-date accuracy, notice timing, quorum/vote thresholds, proxy logistics, and agenda disclosures under charter/bylaws and state statutes. Triggers on requests involving annual meeting notice, shareholder meeting notice, record date, quorum, proxy voting, or annual meeting agenda.
- ▌ Preparing Credit Investment Memoranda · lev-osCreates credit investment memos with borrower analysis, structural assessment, risk evaluation, and relative value positioning. Use when writing credit memos, documenting loan decisions, or presenting credit opportunities.
- ▌ Preparing Private Placement Memoranda · lev-osCreates fund PPM documentation with investment strategy, risk factors, fee disclosure, and regulatory compliance for fund marketing. Use when preparing PPMs, drafting fund marketing materials, or structuring offering documentation.
- ▌ Preparing Real Asset Investment Cases · lev-osStructures real asset investment recommendations with commodity thesis, asset-level analysis, and risk assessment for IC presentation. Use when preparing resource investment cases, building IC materials, or documenting real asset opportunities.
- ▌ Structuring Co Investment Allocations · lev-osDesigns co-invest offerings with allocation methodology, LP terms, and fee/carry structure for direct investment opportunities. Use when structuring co-investments, allocating deal capacity, or managing LP co-invest programs.
- ▌ Structuring Direct Lending Facilities · lev-osDesigns direct lending structures with pricing, covenant packages, and documentation tailored for middle-market borrowers. Use when structuring direct loans, designing covenant packages, or analyzing direct lending terms.
- ▌ Structuring Energy Offtake Agreements · lev-osDesigns power purchase agreements and energy offtake structures with price mechanics, volume commitments, and curtailment provisions. Use when structuring PPAs, analyzing offtake terms, or evaluating energy contract risk.
- ▌ Structuring Fund Vehicle Architecture · lev-osDesigns fund legal structures with master-feeder, parallel fund, and blocker entity configurations for tax-efficient investor access. Use when designing fund structures, selecting vehicle types, or optimizing multi-jurisdictional access.
- ▌ Structuring Infrastructure Fund Terms · lev-osDesigns infrastructure fund structures with longer fund lives, NAV-based distributions, and co-investment programs for illiquid assets. Use when structuring infra funds, designing open-ended vehicles, or analyzing infrastructure fund terms.
- ▌ Managing Advertising Compliance · lev-osReviews marketing materials against SEC, FINRA, and state regulatory requirements. Use when reviewing investment advertising, ensuring compliance of marketing materials, or managing ad review.
- ▌ Managing At The Market Programs · lev-osStructures ATM offering programs with sales agent selection, volume limitations, and disclosure requirements. Use when establishing ATM programs, managing ongoing equity issuance, or optimizing capital raising timing.
- ▌ Managing Bone Marrow Transplant · lev-osGuides BMT/SCT workflow from conditioning through engraftment monitoring and GVHD assessment. Use when managing transplant patients, monitoring engraftment, or assessing GVHD.
- ▌ Managing Capital Call Processes · lev-osStructures capital call execution with notice preparation, pro-rata allocation, default remedy provisions, and wire coordination. Use when processing capital calls, calculating LP contributions, or managing call logistics.
- ▌ Managing Cardiac Rehabilitation · lev-osStructures cardiac rehab prescriptions with exercise parameters and risk stratification. Use when prescribing cardiac rehab, setting exercise targets, or monitoring rehab progress.
- ▌ Managing Chemotherapy Protocols · lev-osVerifies chemotherapy orders against regimen protocols with dose calculations and toxicity monitoring. Use when reviewing chemo orders, calculating BSA-based doses, or tracking treatment toxicity.
- ▌ Managing Chronic Kidney Disease · lev-osTracks CKD staging with eGFR trends, nephrology referral criteria, and medication adjustments. Use when managing CKD, monitoring renal function, or adjusting renally-dosed medications.
- ▌ Managing Clinical Trial Budgets · lev-osStructures trial budget development with per-patient costs, site fees, and sponsor negotiations. Use when budgeting clinical trials, negotiating site contracts, or tracking research expenditures.
- ▌ Managing Community Reinvestment · lev-osStructures CRA compliance monitoring with lending, investment, and service test analysis. Use when managing CRA compliance, analyzing lending patterns, or documenting community investment.
- ▌ Managing Concentrated Positions · lev-osStructures diversification strategies for concentrated single-stock positions with tax and risk considerations. Use when managing concentrated holdings, planning diversification, or evaluating exchange funds.
- ▌ Managing Data Safety Monitoring · lev-osStructures DSMB operations with interim analysis protocols and stopping rules. Use when managing DSMBs, conducting interim analyses, or implementing stopping criteria.
- ▌ Managing Deal Process Execution · lev-osCoordinates buy-side deal execution from LOI through closing with workstream tracking, timeline management, and closing conditions. Use when managing deal processes, tracking closing conditions, or coordinating deal teams.
- ▌ Managing Disability Evaluations · lev-osStructures psychiatric disability assessments with functional limitations and work capacity documentation. Use when evaluating psychiatric disability, documenting functional limitations, or completing disability forms.
- ▌ Managing Emergency Preparedness · lev-osStructures public health emergency preparedness with hazard vulnerability and response planning. Use when planning emergency preparedness, conducting vulnerability assessments, or developing response plans.
- ▌ Managing Estimated Tax Planning · lev-osStructures quarterly estimated tax planning with safe harbor calculations and penalty avoidance strategies. Use when planning estimated taxes, calculating safe harbor payments, or avoiding underpayment penalties.
- ▌ Managing Eu Taxonomy Compliance · lev-osStructures EU Taxonomy alignment assessment with technical screening criteria and DNSH evaluation. Use when assessing Taxonomy alignment, applying technical criteria, or evaluating substantial contribution.
- ▌ Managing Fair Value Measurement · lev-osApplies ASC 820 fair value framework with hierarchy classification and valuation technique documentation. Use when measuring fair values, classifying in the fair value hierarchy, or documenting valuation approaches.
- ▌ Managing Fund Audit Preparation · lev-osStructures fund audit preparation with financial statement drafting, confirmation management, and workpaper organization. Use when preparing for fund audits, drafting fund financials, or managing audit confirmations.
- ▌ Managing Global Health Programs · lev-osStructures international health program design with WHO guidelines and cross-cultural considerations. Use when managing global health initiatives, applying WHO frameworks, or designing international health programs.
- ▌ Managing Good Clinical Practice · lev-osApplies GCP/ICH principles to clinical research operations with compliance monitoring. Use when ensuring GCP compliance, training on ICH guidelines, or auditing research practices.
- ▌ Managing Health Data Governance · lev-osStructures health data governance programs with stewardship roles, policies, and data quality standards. Use when establishing data governance, defining data stewardship, or managing data policies.
- ▌ Conducting Discharge Planning Nursing · lev-osCoordinates nursing discharge planning with medication teaching, follow-up scheduling, and resource coordination. Use when planning discharge, coordinating post-discharge care, or documenting discharge teaching.
- ▌ Conducting Peer Benchmarking Analysis · lev-osEvaluates fund performance against peer universes with vintage year comparison, quartile ranking, and strategy-specific benchmarking. Use when benchmarking fund performance, analyzing vintage comparisons, or assessing relative positioning.
- ▌ Conducting Stress Test Interpretation · lev-osInterprets exercise and pharmacologic stress tests with Duke treadmill score and nuclear findings. Use when reading stress tests, interpreting nuclear perfusion, or documenting exercise tolerance.
- ▌ Conducting Traffic And Demand Studies · lev-osEvaluates demand forecasts for toll roads, airports, and ports with independent engineer review and scenario sensitivity analysis. Use when analyzing traffic studies, validating demand forecasts, or stress testing revenue projections.
- ▌ Coordinating Multidisciplinary Rounds · lev-osSynthesizes input from nursing, pharmacy, PT/OT, social work, and case management into unified care plans. Use when conducting interdisciplinary rounds, coordinating care teams, or documenting team-based decisions.
- ▌ Data Retention And Destruction Policy · lev-osDrafts a law firm Data Retention and Destruction Policy covering practice-area retention schedules, secure destruction procedures, legal hold protocols, and compliance infrastructure. Trigger when establishing or updating records management frameworks, drafting retention schedules by matter type, or implementing secure destruction procedures for paper and electronic records.
- ▌ Documenting Tumor Board Presentations · lev-osStructures multidisciplinary tumor board case presentations with radiology, pathology, and treatment synthesis. Use when preparing tumor board cases, presenting MDT discussions, or documenting consensus recommendations.
- ▌ Drafting Equity Offering Prospectuses · lev-osStructures S-1/F-1 prospectus content with business description, risk factors, MD&A, and financial presentation requirements. Use when preparing IPO prospectuses, drafting SEC filings, or structuring offering documents.
- ▌ Evaluating Post Reorganization Equity · lev-osAssesses post-emergence equity with clean balance sheet analysis, improved capital structure, and re-rating potential. Use when evaluating post-reorg equity, analyzing emergence opportunities, or assessing restructured company value.
- ▌ Managing Blood Product Administration · lev-osGuides blood product administration with verification, monitoring, and transfusion reaction management. Use when administering blood products, monitoring transfusions, or managing transfusion reactions.
- ▌ Managing Business Succession Planning · lev-osStructures business exit and succession planning with valuation, buyer identification, and tax strategy. Use when planning business succession, valuing private businesses, or structuring ownership transitions.
- ▌ Managing Capital Expenditure Planning · lev-osStructures capex evaluation with ROI analysis, approval workflows, and project tracking. Use when evaluating capital projects, analyzing investment returns, or managing capex budgets.
- ▌ Managing Central Clearing Obligations · lev-osCoordinates central clearing requirements with CCP selection, margin optimization, and clearing threshold monitoring. Use when managing clearing obligations, optimizing CCP selection, or analyzing clearing economics.
- ▌ Managing Charitable Giving Strategies · lev-osStructures charitable planning with vehicle selection, tax benefit optimization, and legacy impact analysis. Use when planning charitable giving, evaluating donor-advised funds, or structuring foundation contributions.
- ▌ Managing Clinical Imaging Informatics · lev-osStructures radiology informatics workflows with PACS integration and DICOM standards. Use when managing imaging informatics, integrating PACS systems, or implementing DICOM workflows.
- ▌ Managing Commercial Loan Underwriting · lev-osStructures commercial loan underwriting with financial spreading, cash flow analysis, and risk rating. Use when underwriting commercial loans, analyzing borrower financials, or assigning risk ratings.
- ▌ Managing Concentrated Stock Positions · lev-osEvaluates strategies for concentrated equity positions with tax-efficient diversification and hedging analysis. Use when managing concentrated positions, planning diversification, or evaluating hedging strategies.
- ▌ Managing Cross Border Settlement Risk · lev-osEvaluates settlement risk in cross-border transactions with time zone analysis, CLS participation, and Herstatt risk mitigation. Use when managing settlement risk, analyzing CLS eligibility, or evaluating cross-currency settlement.
- ▌ Managing Emerging Risk Identification · lev-osStructures emerging risk scanning with horizon analysis and early warning indicator development. Use when identifying emerging risks, scanning for new threats, or developing early warning systems.
- ▌ Managing Evaluation Management Coding · lev-osApplies 2021+ E/M guidelines with medical decision-making or time-based code selection. Use when coding E/M services, determining MDM level, or selecting E/M codes.
- ▌ Managing Insurance Regulatory Filings · lev-osStructures statutory filing preparation with SAP differences, risk-based capital, and annual statement schedules. Use when preparing statutory filings, calculating RBC, or managing regulatory submissions.
- ▌ Creating Dental Treatment Plans · lev-osStructures dental treatment planning with phasing, cost estimation, and alternative options presentation. Use when creating treatment plans, phasing dental work, or presenting treatment options.
- ▌ Designing Observational Studies · lev-osStructures observational study designs (cohort, case-control, cross-sectional) with bias mitigation strategies. Use when designing observational research, mitigating bias, or planning epidemiologic studies.
- ▌ Dividend Declaration Resolution · lev-osDrafts a board of directors resolution authorizing a cash, stock, or property dividend to shareholders. Enforces solvency testing (equity and balance sheet), WHEREAS/RESOLVED clause structure, critical date triad (declaration/record/payment), officer authorization, and Secretary certification under Delaware DGCL §170 or equivalent state statute. Use when documenting board approval of a dividend distribution or when corporate governance records require a formal profit-distribution authorization.
- ▌ Document Production Log Summary · lev-osGenerates a structured log and strategic summary of opposing-party document productions in U.S. litigation discovery. Categorizes by type, date, custodian, and relevance; flags hot documents; tracks privilege assertions per FRCP 26(b)(5); identifies production gaps. Use when organizing voluminous productions, surfacing critical evidence, assessing completeness, or supporting meet-and-confer and motion to compel decisions.
- ▌ Documenting Mental Status Exams · lev-osCreates structured MSE documentation covering appearance, behavior, speech, mood, thought, cognition, and insight. Use when documenting mental status, writing MSE sections, or describing psychiatric findings.
- ▌ Documenting Psychotherapy Notes · lev-osStructures psychotherapy documentation meeting billing and clinical requirements. Use when documenting therapy sessions, writing progress notes, or recording psychotherapy interventions.
- ▌ Documenting Telemedicine Visits · lev-osStructures telehealth encounter documentation with technology modality, clinical limitations, and follow-up planning. Use when documenting virtual visits, recording telemedicine encounters, or managing remote patient care.
- ▌ Evaluating Country Risk Factors · lev-osAssesses country-level investment risk with political stability, rule of law, corruption indices, and expropriation history analysis. Use when evaluating country risk, assessing political exposure, or scoring sovereign investment environments.
- ▌ Expert Medical Record Omissions · lev-osAnalyzes expert witness reports, depositions, and testimony to identify gaps in medical record review, map conflicts to the full record set, and produce impeachment and admissibility analysis with pinpoint citations. Use when reviewing expert reports for missing medical records, selective review patterns, Daubert/Frye challenges, cross-examination prep, motions to exclude or limit, or rebuttal expert focus in personal injury or medical malpractice litigation.
- ▌ Field Of Use Restriction Clause · lev-osDrafts enforceable Field of Use restriction clauses for U.S. IP licensing agreements (patent, software, trade secret, know-how). Covers permitted and restricted applications, sublicense limits, derivative-use treatment, audit and compliance mechanics, and remedy framework. Use when narrowing licensee exploitation rights, setting enforcement triggers, or preserving licensor rights outside scope during negotiation or formation. Triggers: field of use, permitted use, restricted use, sublicensing, derivative works, audit rights, IP licence scope, patent software licensing.
- ▌ Foreclosure Proceedings Summary · lev-osGenerates structured chronological summaries of U.S. foreclosure proceedings from case documents. Extracts parties, property, loan info, procedural timeline, judicial decisions, deadlines, and current status. Flags bankruptcy stays, loss mitigation holds, standing challenges, RESPA/TILA issues, and procedural irregularities. Distinguishes judicial vs. non-judicial procedures. Use when summarizing foreclosure case posture for lender representation, borrower defense, or real estate transactions affected by pending foreclosure.
- ▌ Fraudulent Conveyance Complaint · lev-osDrafts a U.S. fraudulent conveyance complaint to avoid and recover debtor asset transfers under UFTA, UVTA, or state equivalents. Covers actual fraud (UVTA § 4(a)(1)), constructive fraud theories, badges of fraud, provisional remedies, and full prayer for relief. Use when a creditor needs to challenge a transfer made to hinder, delay, or defraud creditors, including bankruptcy adversary proceedings. Triggers: fraudulent conveyance, fraudulent transfer, voidable transaction, badges of fraud, asset concealment, debtor insolvency, UFTA, UVTA, avoidance action.
- ▌ Interpreting Cytology Specimens · lev-osStructures cytology interpretation with Bethesda system for cervical and other body site classifications. Use when reading cytology, applying Bethesda classifications, or documenting cytologic findings.
- ▌ Interpreting Electrocardiograms · lev-osSystematically interprets 12-lead ECGs with rate, rhythm, axis, intervals, and morphology analysis. Use when reading ECGs, documenting EKG interpretations, or identifying cardiac arrhythmias.
- ▌ Interpreting Surgical Pathology · lev-osStructures surgical pathology reports with diagnosis, staging, margins, and prognostic markers. Use when interpreting biopsies, creating pathology reports, or documenting tissue diagnoses.
- ▌ Interpreting Toxicology Screens · lev-osStructures drug screen interpretation with confirmation testing and clinical correlation. Use when interpreting drug screens, managing confirmatory testing, or documenting toxicology results.
- ▌ Invasive Testing Consent Letter · lev-osDrafts a Phase II invasive testing consent letter that limits scope, locations, timing, data control, restoration, security, and risk allocation under an existing access, due diligence, or purchase and sale agreement. Use this skill when a counterparty requests soil borings, test pits, groundwater wells, soil vapor sampling, or other intrusive ESA activities. Trigger on keywords including "Phase II," "invasive testing," "environmental site assessment," "ESA," "borings," "test pits," "monitoring wells," "restoration bond," "PLL insurance," "access agreement," "consent letter," "IDW handling," or "environmental due diligence." Even if the user just says "they want to do borings on the site" or "draft consent for Phase II," use this skill.
- ▌ Investigating Disease Outbreaks · lev-osGuides outbreak investigation using CDC steps with case definition, epidemiologic curve, and control measures. Use when investigating outbreaks, analyzing epidemic curves, or implementing control measures.
- ▌ Managing Adverse Drug Reactions · lev-osClassifies and documents adverse drug reactions with causality assessment (Naranjo) and reporting. Use when evaluating ADRs, assessing drug causality, or reporting adverse events.
- ▌ Analyzing Central Bank Balance Sheets · lev-osStructures central bank balance sheet analysis with QE/QT impact assessment and reserve management. Use when analyzing central bank operations, evaluating QE effects, or tracking reserve management.
- ▌ Analyzing Competitive Moat Durability · lev-osEvaluates competitive advantage sustainability with switching costs, network effects, data assets, and brand strength analysis. Use when assessing competitive moats, analyzing defensibility, or evaluating long-term positioning.
- ▌ Analyzing Deal Financing Alternatives · lev-osCompares financing alternatives including debt, equity, convertibles, and hybrid instruments for transactions. Use when evaluating financing options, comparing capital structure alternatives, or optimizing deal funding.
- ▌ Analyzing Debt Capacity And Structure · lev-osEvaluates target leverage capacity with cash flow coverage, stress testing, and optimal debt structure across term loans, revolver, and mezzanine. Use when analyzing debt capacity, structuring acquisition financing, or stress testing leverage.
- ▌ Analyzing Decommissioning Obligations · lev-osEvaluates asset retirement and decommissioning liabilities with cost estimation, timing analysis, and funding adequacy assessment. Use when analyzing decommissioning costs, evaluating ARO exposure, or assessing abandonment liability.
- ▌ Analyzing Fairness Opinion Valuations · lev-osEvaluates fairness opinion methodologies across DCF, trading comps, and precedent transactions for board-level decisions. Use when reviewing fairness opinions, preparing board materials, or analyzing transaction fairness.
- ▌ Analyzing Frontier Market Investments · lev-osEvaluates frontier market opportunities with liquidity constraints, custody risk, settlement infrastructure, and governance assessment. Use when analyzing frontier markets, assessing operational risk, or evaluating frontier market access.
- ▌ Analyzing Investor Concentration Risk · lev-osMonitors LP base composition with concentration analysis, redemption risk, and re-up probability assessment. Use when analyzing investor concentration, assessing re-up risk, or managing LP base diversification.
- ▌ Analyzing Key Person Event Provisions · lev-osEvaluates key person clause triggers, consequences, and cure mechanics in partnership documentation. Use when analyzing key person provisions, assessing management stability risk, or structuring departure protections.
- ▌ Analyzing Local Currency Debt Markets · lev-osEvaluates local currency government and corporate bond markets with yield analysis, inflation dynamics, and FX carry assessment. Use when analyzing local currency debt, evaluating EM bond opportunities, or assessing carry strategies.
- ▌ Analyzing Oilfield Services Economics · lev-osEvaluates OFS sector investments with rig count sensitivity, day rate analysis, and technology adoption curves. Use when analyzing oilfield services, evaluating service company economics, or assessing technology uptake.
- ▌ Analyzing Secondary Credit Facilities · lev-osEvaluates secondary-focused credit facilities with leverage terms, borrowing base mechanics, and portfolio pledging requirements. Use when analyzing secondary lending, structuring portfolio leverage, or evaluating fund finance options.
- ▌ Analyzing Spac Transaction Structures · lev-osEvaluates SPAC de-SPAC transaction economics with sponsor dilution, redemption risk, PIPE analysis, and warrant impact. Use when analyzing SPAC deals, evaluating sponsor economics, or modeling de-SPAC outcomes.
- ▌ Analyzing Sustainable Debt Structures · lev-osEvaluates green bonds, sustainability-linked bonds, and social bonds with KPI selection, step-up mechanics, and framework assessment. Use when structuring ESG-linked debt, analyzing sustainability frameworks, or evaluating green bond eligibility.
- ▌ Analyzing Volatility Surface Dynamics · lev-osEvaluates implied volatility surfaces with skew analysis, term structure dynamics, and surface fitting methodologies. Use when analyzing vol surfaces, assessing skew dynamics, or calibrating volatility models.
- ▌ Analyzing Water Rights And Allocation · lev-osEvaluates water rights valuation with seniority analysis, regulatory framework assessment, and allocation risk for resource investments. Use when analyzing water rights, evaluating water allocation, or assessing water risk.
- ▌ Building Statistical Arbitrage Models · lev-osConstructs stat arb strategies with pair selection, signal generation, and portfolio optimization under market neutrality constraints. Use when building stat arb models, designing market-neutral strategies, or optimizing pair portfolios.
- ▌ Class Settlement Preliminary Approval · lev-osDrafts a Motion for Preliminary Approval of Class Action Settlement under Rule 23(e), covering settlement class certification, notice plan, claims administration, fairness analysis, and proposed scheduling order. Use when drafting preliminary approval motions, class action settlement filings, or Rule 23(e) submissions.
- ▌ Clinical Trial Investigator Agreement · lev-osDrafts U.S. clinical trial Investigator Agreements between sponsors/CROs and principal investigators or institutions for FDA-regulated drug, biologic, or device studies. Enforces 21 CFR Parts 50, 56, 312/812, ICH GCP E6(R2), HIPAA, IRB requirements, FMV/AKS payment compliance, data integrity, publication rights, IP ownership, indemnity, and audit access. Use when drafting investigator agreements, PI agreements, clinical trial site agreements, or sponsor-PI contracts; trigger keywords: investigator agreement, clinical trial agreement, PI agreement, FDA, IND, IDE, IRB, GCP, clinical research agreement, site agreement.