A study’s research record must include documentation that each participant has met all the eligibility criteria outlined in the IRB-approved protocol/application. This documentation provides evidence that participants were appropriate for participation. One way to document eligibility is by using an eligibility checklist. UW ICTR has an eligibility checklist template that can be modified to work for your particular study. When creating an eligibility checklist, ensure you are capturing all the criteria that were approved by the IRB. If you find that the criteria need to be modified, a Change of Protocol must be submitted prior to making any modifications.