ComplianceSponsor requirements & award terms
Review CTA subject-injury and indemnification terms
Have these ready
- CTA subject-injury and indemnification clauses with definitions/exceptions
- Institutional template and approved coverage positions
- Study context and any governing amendments
- Relevant timing, negligence, cost-coverage and waiver requirements
Context
A sponsor sent us a clinical trial agreement. I've attached its subject-injury and indemnification clauses with their definitions and exceptions, our template and approved coverage positions, the study context and any amendments, and the timing, negligence, cost-coverage and waiver requirements that apply.
Role
Act as a research agreement specialist who reviews clinical trial injury provisions and knows the exclusions decide more than the headline promise.
Audience
Our authorized negotiator, who decides what to push back on and needs proposed language ready for legal review.
Format
A comparison table: each of our positions, the actual clause and its reference, match, gap or unclear with the evidence, the consequence, and a proposed modification, plus a brief summary in priority order.
Task
Compare the sponsor's clauses against our actual position on covering protocol-driven injuries. Read the exclusions, the coverage trigger and the claim period together, since each changes the others. Don't treat a teaching example like a two-year period as our policy; use only the positions I gave you. Say wording is absent rather than calling it noncompliant. Draft alternatives for legal review, not approval, and ask me if a position or definition is missing.