# Hls Identify Cta Issues Scenario 02 > Reviews a proposed clinical trial agreement against an institutional research playbook to identify governing-law choice issues, exclusion-screening cadence gaps, fair-market-value concerns for compensation, side-letter governance bypass risks, pass-through cost-control gaps, liability-allocation issues for protocol deviations, and safety-reporting misalignment. - Skill: `finchipaiorg/hls-identify-cta-issues-scenario-02` (Agent Skill) - Install (CLI): `npx skillmds@latest add finchipaiorg/hls-identify-cta-issues-scenario-02` - Raw SKILL.md: https://api.skillmd.com/api/skills/finchipaiorg/hls-identify-cta-issues-scenario-02/raw - Safety review: pending - Works with: Claude Code, Claude.ai, OpenAI Codex - Category: Research & Search - Author: FinchipAIOrg (https://skillmd.com/u/finchipaiorg) - Updated: 2026-09-22 - Page: https://skillmd.com/skills/finchipaiorg/hls-identify-cta-issues-scenario-02 --- # Skill: Clinical Trial Agreement Issue Identification — Scenario 02 ## 1. Subject-matter triage - Treat the CTA, side letter, and supporting materials as one integrated source set. - Separate core agreement terms from ancillary documents, then test whether the ancillary papers create rights, duties, or operational workarounds that override the CTA. - Identify whether the institution is the site, the sponsor-facing counterparty, or an operationally burdened third party, because the review standard turns on that role. - If only one governing-law clause, one exclusion-screening regime, or one compensation structure is present, say so affirmatively before analyzing it; otherwise enumerate each variant and evaluate each separately. ## 2. Failure modes the skill is correcting - A governing-law clause is accepted without checking whether it fits the institution’s home-state compliance structure and dispute posture. - An exclusion-screening covenant is read as a one-time onboarding obligation when the text or playbook requires recurring review. - Compensation tied to enrollment, procedures, or per-subject activity is not tested for fair-market-value support or compliance safeguards. - A side letter or informal communication creates direct sponsor-to-investigator access that bypasses the institutional research office or equivalent oversight channel. - Pass-through reimbursement language is treated as routine even though it leaves cost scope, cap, or prior-approval mechanics undefined. - Protocol-deviation language fails to allocate regulatory response, corrective action, and reporting responsibilities with enough precision. - Safety-reporting duties are not reconciled across sponsor, investigator, site, and institution documents, creating timing or recipient conflicts. ## 3. Legal frameworks / domain conventions that apply - Governing law in CTAs: identify the chosen law and assess whether it is consistent with the institution’s location, compliance structure, and dispute-resolution implications for research operations. - Exclusion screening: confirm whether the text requires screening only at onboarding or also on a recurring cadence; compare that obligation to applicable exclusion-screening guidance and local compliance practice. - Compensation and fair market value: review whether subject-based compensation or site payments depend on volume, procedures, or enrollment milestones, and whether the agreement includes an FMV representation, certification, or validation process. - Side-letter governance: check whether any ancillary document grants sponsor personnel direct operational access to the investigator or site outside the research office, and treat that as an oversight-risk issue. - Pass-through costs: verify whether reimbursable direct costs are defined, capped, and subject to prior approval above a threshold; open-ended pass-through language is a cost-control issue. - Protocol deviations: assess whether the agreement clearly allocates responsibility for deviation response, corrective action, escalation, and regulatory follow-up among sponsor and site personnel. - Safety reporting: compare sponsor, investigator, and institutional reporting duties, recipients, and timelines across all documents to ensure the parallel pathways align. - Use the controlling authority that actually supports the compliance point being made; do not state a conclusion without naming the governing rule, regulation, or recognized authority behind it. ## 4. Analytical scaffolds 1. Governing law - Identify the law selected in the CTA. - Compare it to the institution’s home jurisdiction and any forum or enforcement implications. - Flag any mismatch that could affect interpretation, oversight, or litigation posture. 2. Exclusion screening - Determine whether the agreement requires only initial screening or also recurring screening. - Compare the text to the applicable compliance standard and the institution’s practice. - State whether the cadence is complete, ambiguous, or under-specified. 3. Fair-market-value compensation - Determine whether compensation is tied to patient volume, procedures, enrollment, or other activity metrics. - Check for a documented FMV safeguard, certification, or review step. - Assess whether the payment structure creates an inducement, compliance, or audit-risk question. 4. Side letter bypass - Review all ancillary documents for direct operational rights, escalation channels, or contact provisions that route around the research office. - Determine whether the side letter changes the operational control structure or merely clarifies logistics. - Flag any bypass of institutional oversight as a governance issue. 5. Pass-through cost cap - Identify the reimbursement framework for direct costs and pass-through expenses. - Check for a defined cap, exclusions, and any prior-approval threshold. - Compare the text to the institutional playbook and note whether cost exposure is bounded. 6. Dual liability for deviations - Identify how the CTA allocates responsibility for protocol deviations, corrective action, and related regulatory response. - Test whether sponsor and site obligations are redundant, inconsistent, or incomplete. - State the operational, regulatory, or litigation consequence of any ambiguity. 7. Safety reporting alignment - Confirm that sponsor, investigator, site, and institutional reporting duties are consistent across the CTA, side letter, and incorporated materials. - Check timing, recipient, and content requirements for conflicts. - Flag any mismatch that could cause delayed reporting or duplicated reporting. 8. Issue closure - For each issue, identify the specific clause or omission. - Tie the issue to the governing authority or institutional standard. - State the practical consequence for the client and the recommended fix. ## 5. Vertical / structural / temporal relationships - Read the CTA first, then test whether the side letter narrows, expands, or bypasses it. - Treat incorporated exhibits, schedules, and support materials as controlling for operational details when the CTA points to them. - If a later document conflicts with an earlier one, identify the conflict and specify which term should be harmonized. - Distinguish between one-time obligations, ongoing obligations, and milestone-based obligations, because different compliance risks attach to each. - Where multiple parties have parallel duties, map who acts first, who receives notice, and who bears escalation responsibility. ## 6. Output structure conventions - Produce a prioritized issues memorandum, not a summary of the deal. - Use an ordinal severity scale defined once at the top, and apply it uniformly to every issue. - For each issue, include: - the clause or omission at issue; - the governing or compliance basis; - the severity level; - the client consequence; - the recommended revision or negotiation point. - When a source document supplies a threshold, timing anchor, or numeric trigger, use it in the issue analysis; do not invent unsupported arithmetic. - End with a concise Recommended Actions block that assigns each next step to a role and a timing anchor tied to the transaction or compliance workflow. - Keep recommendations operational and specific; diagnoses without a fix are incomplete. - Use conventional memorandum headings rather than the rubric’s internal section names.