Investigator-Initiated Study Coverage Extension
What this clause says
Sponsor's Clinical Trial Liability policy shall extend coverage to investigator-initiated studies (IIS) supported by Sponsor, naming the investigator-sponsor as additional insured with respect to Sponsor's investigational product, protocol, and provided materials.
What this means in plain English
A clinical trial liability extension covering investigator-initiated studies — clinical trials run by an independent investigator (typically at an academic medical center) under that investigator's own IND, with financial or in-kind support from a pharma sponsor. Coverage typically follows the sponsor's investigational product and provided materials, with the investigator-sponsor named as additional insured.
What it means for a CDMO program
Pharma sponsors supporting IIS arrangements should verify their CTL policy explicitly covers IIS activity and that the IIS support agreement aligns with policy wording. Coverage scope is usually narrower than for sponsor-led trials and should be documented carefully in both the policy and the support agreement.
How this evaluates
The Decoder applies these rules in order; the first match wins.
- iis › coverage in place is set → Compliant: IIS coverage extension confirmed.
- iis › coverage in place is not set → Borderline: No explicit IIS coverage indicated.
See this in your MSA
Pre-loaded with this clause selected.
Run the Decoder