Scenario 02

---
name: hls-identify-cta-issues-scenario-02
task_id: healthcare-life-sciences/identify-clinical-trial-agreement-issues/scenario-02
description: 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.
activates_for: [planner, solver, checker]
---

# 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.