The following tools were developed by the Informed Consent project team to assist researchers (at the site and sponsor) in using CTTI's recommendations to improve the informed consent process. These tools, which are included as appendices of the recommendations document ( https://www.ctti-clinicaltrials.org/files/ctti-informedconsent-recs.pdf ) , are available below in editable formats that may be customized to meet your organizational needs.
Tool 1. Informed Consent Discussion Tool (Word) https://www.ctti-clinicaltrials.org/files/ctti-ic-recs-tool1.docx
Researchers can use this tool to guide conversation during the consent process, ensuring the specific needs of each study participant are considered, key elements of the trial are reviewed and addressed, and interactive techniques are used to facilitate participant understanding of the information imparted. This tool could be used for documenting the informed consent process, but should not be viewed as a regulatory compliance document.
Tool 2. Informed Consent Training Resources (Word) https://www.ctti-clinicaltrials.org/files/ctti-ic-recs-tool2.docx
Research sites can use this tool to evaluate external informed consent training resources to determine if the resource meets the needs of the site’s training program.
Tool 3. Sample Tiered Informed Consent Model (Word) https://www.ctti-clinicaltrials.org/files/ctti-ic-recs-tool3.docx
Research sites, research sponsors, CROs, and IRBs can use this tool to better understand the basic structure of the Tiered Informed Consent Model document. It is not intended to be an informed consent document template.