# Hls Draft Markup Cta > Produces a fully marked-up institutional redline of a sponsor-drafted clinical trial agreement, aligning the draft to the applicable institutional research position on indemnification causation, publication rights, adverse-event reporting, protocol amendment review, and government-funding / invention-ownership considerations. - Skill: `finchipaiorg/hls-draft-markup-cta` (Agent Skill) - Install (CLI): `npx skillmds@latest add finchipaiorg/hls-draft-markup-cta` - Raw SKILL.md: https://api.skillmd.com/api/skills/finchipaiorg/hls-draft-markup-cta/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-draft-markup-cta --- # Skill: Draft Markup of Clinical Trial Agreement ## 1. Subject-matter triage - Confirm the controlling inputs before drafting: the sponsor CTA, institutional playbook, engagement email, budget, and protocol synopsis. - Treat the CTA as the primary deliverable; any commentary or cover note is secondary to the redlined agreement itself. - Map the study type, funding posture, reporting regime, and amendment workflow before revising individual clauses. - If more than one institutional position, study arm, reporting channel, or funding source is implicated, separate them explicitly before analysis rather than blending them into one pass. ## 2. Failure modes the skill is correcting - A draft may identify the right issue but fail to convert it into an operative clause change. - Indemnification may be narrowed by causation wording that is left untouched instead of aligned to the institution’s preferred formulation and sponsor-negligence qualifier. - Publication may preserve a sponsor consent right when the playbook calls for review-and-comment, a defined review window, a dispute path, and a deemed-response fallback. - Safety reporting may be left on sponsor-preferred timelines instead of tracking the applicable regulatory reporting framework for the study. - Protocol amendment language may omit the required ethics committee / IRB review condition before implementation. - Funding and invention language may ignore public-support implications, government interests, or required representations about the absence of such support. - Commentary may describe the issue without tying it to a playbook position, a governing authority, and a practical consequence for the institution. - A markup that depends only on formatting can fail in export; each substantive change must be legible from the text alone. ## 3. Legal frameworks / domain conventions that apply - Indemnification: identify any narrow causation formulation and align it to the institution’s preferred causation standard, including the sponsor-negligence qualifier required by the playbook. - Publication rights: where the sponsor holds approval or consent rights, convert the provision to a review-and-comment structure with a defined review period, dispute handling, and deemed approval or no-response treatment consistent with the playbook. - Adverse-event reporting: align reporting obligations to the applicable research-safety framework, including expedited reporting windows for serious unexpected events and fatal or life-threatening events where those rules apply. - Protocol amendments: require ethics committee / IRB review before implementation whenever the governing study category or institutional position calls for that sequencing. - Government funding and invention ownership: if public support or other governmental funding is implicated, address statutory rights, confirm any needed representation regarding such support, and harmonize ownership language with the applicable funding regime. - Research-contract conventions: revise only what the source documents and playbook support; do not import sponsor-favorable defaults where the institution position is more protective. - Authority discipline: every substantive legal proposition should be anchored to the governing rule, regulation, or accepted research-contract authority reflected in the source materials or standard practice. ## 4. Analytical scaffolds 1. Indemnification review - Locate any causation qualifier, limitation, carve-out, or attribution standard. - Redline the text to the institutional position. - Add a concise rationale tied to the playbook and the practical risk allocation consequence. 2. Publication review - Identify any sponsor approval, veto, delay, or preclearance right. - Replace it with review-and-comment mechanics if required. - Include the review period, response mechanics, and fallback language. - Explain how the revised clause preserves academic publication rights while protecting confidential information. 3. Safety reporting review - Check whether each reporting obligation matches the study’s governing safety-reporting regime. - Harmonize internal reporting, sponsor reporting, and any expedited external reporting obligations. - Where multiple reporting channels exist, specify them separately so timing does not become ambiguous. 4. Protocol amendment review - Confirm whether amendments require prior ethics committee / IRB review or approval before implementation. - Ensure the clause distinguishes administrative changes from substantive protocol changes if the source documents do so. - State the operational consequence of noncompliance with the required sequencing. 5. Funding and invention-ownership review - Determine whether public funding or analogous support is implicated by the source materials. - If yes, add the needed representation and align ownership / government-interest language accordingly. - If no, preserve a clean representation without overcommitting beyond the record. 6. Commentary drafting - Assign each issue an ordinal severity label using a defined scale: Red, Yellow, or Green. - Use Red for provisions that materially conflict with the institutional position or regulatory framework, Yellow for negotiable but material points, and Green for nonmaterial cleanups or drafting polish. - For each entry, state the governing basis, the cross-referenced document or clause interaction, and the downstream consequence for the institution. 7. Redline execution - Make every substantive edit visible in the text itself using robust markup that survives export. - Pair each deletion, insertion, or substitution with a short rationale. - Keep comments targeted to the changed language; do not restate the full agreement. ## 5. Vertical / structural / temporal relationships - Track the order in which obligations occur: protocol review before implementation, reporting after event identification, publication review before submission, and funding representation at contract formation. - Distinguish sponsor obligations from institution obligations, and internal review steps from external regulatory steps. - When one clause affects another, note the interaction explicitly so the revised text reads consistently across definitions, operational clauses, and exhibits. - If the study synopsis, budget, or engagement email narrows the clause scope, conform the redline to that narrower record rather than the sponsor’s broader form. ## 6. Output structure conventions - Deliver a fully marked-up redline of the CTA as the operative document, suitable for export to `marked-up-cta-vlx4190-301.docx`. - Use explicit textual markup for every substantive change, such as [DELETED: ...], [INSERTED: ...], and [REPLACED: old → new], so the changes remain clear in plain text. - Attach a short [Rationale: ...] note to each substantive change or cluster of related changes. - Include commentary alongside the markup or in adjacent notes, with one entry per issue and a defined severity label from the ordinal scale stated above. - Keep commentary concise but complete: identify the clause, state the basis, reference the interacting source document or related clause, and explain the practical consequence. - End with a brief Recommended Actions section that states the next step, the responsible role, and the timing anchor tied to the study workflow or signature process. - Preserve the agreement’s operative drafting style; do not substitute a memo or checklist for the redlined contract.