Sponsored Projects' clinical trials contract & budget
The Office of Sponsored Projects will ensure that the clinical trial agreement contains appropriate language from the study sponsor that meets AAHRPP accreditation guidelines. AAHRPP’s goal in including the four clauses below is meant to increase patient participant protections from the research institution’s perspective.
- Research-related injury clause compensation in the CTA and consent form are consistent.
- The Sponsor will notify study sites of any findings that could impact participants’ safety, decision to participate or continue participation, influence the study conduct, or the IRB’s assessment of and decision to approve the study.
- The Sponsor will provide information of material importance to trial participants’ safety and that could impact participants’ decision to enroll or continue participation in a timely fashion throughout study trial conduct.
- If the Sponsor identifies issues of concern about the study trial, device or drug used in the research, or other study-related issues following closure of the study that affect study participants’, the Sponsor will notify the study site(s) and provide materials to inform participants of the issues of concern.