Are the subject’s records absent of evidence to suggest non-authorized IU HRPP Policies: Reportable Events 2.1, Research access, use, or disclosures? Personnel Responsibilities 2.5, Use of PHI in Research 2.1, 3.6 Note: including access, use, or disclosure by a non-IRB-approved study team member? Not Eligibility Yes No N/A REFERENCES Reviewed Is there appropriate documentation that the subject met/didn’t meet eligibility criteria (including applicable medical records to confirm subject’s eligibility), and □ □ □ □ that eligibility was confirmed prior to ICH GCP E6 (R2) 4.5.2 continuing with post-screening procedures (including prior to exposure to the FDA 21 CFR 312.60, 812.100 investigational agent)? IU HRPP Policies: Research Personnel Responsibilities 2.3, 2.4 If not, are approval waivers present for (from both sponsor and IRB) □ □ □ □ inclusion/exclusion criteria not fulfilled by subject, if applicable? ICH GCP E6 (R2) 2.8, 4.1.5, 4.3.1 FDA Guidance for Industry: Investigator Responsibilities Protecting the Rights, Safety, – and Welfare of Study Subjects Was eligibility assessed by an □ □ □ □ appropriately qualified and delegated IU HRPP Policies: Research Personnel individual (including KC-IRB designation)? Responsibilities 2.1 IU HRPP Guidance: Investigators ICH GCP E6 (R2) 4.5.1, 4.5.2 Were all screening or pre- enrollment / □ □ □ □ randomization activities completed per IU HRPP Policies: Research Personnel protocol? Responsibilities 2.3 Intervention Not Yes No N/A REFERENCES & Outcomes Reviewed
Are the subject’s records absent of evidence to suggest non-authorized access, use, or disclosures? Note: including access, use, or disclosure by a non-IRB-approved study team member? IU HRPP Policies: Reportable Events 2.1, Research Personnel Responsibilities 2.5, Use of PHI in Research 2.1, 3.6 Eligibility Yes No N/A Not Reviewed REFERENCES Is there appropriate documentation that the subject met/didn’t meet eligibility criteria (including applicable medical records to confirm subject’s eligibility), and that eligibility was confirmed prior to continuing with post-screening procedures (including prior to exposure to the investigational agent)? □ □ □ □ ICH GCP E6 (R2) 4.5.2 FDA 21 CFR 312.60, 812.100 IU HRPP Policies: Research Personnel Responsibilities 2.3, 2.4 If not, are approval waivers present (from both sponsor and IRB) for inclusion/exclusion criteria not fulfilled by subject, if applicable? □ □ □ □ Was eligibility assessed by an appropriately qualified and delegated individual (including KC-IRB designation)? □ □ □ □ ICH GCP E6 (R2) 2.8, 4.1.5, 4.3.1 FDA Guidance for Industry: Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects IU HRPP Policies: Research Personnel Responsibilities 2.1 IU HRPP Guidance: Investigators Were all screening or pre- enrollment / randomization activities completed per protocol? □ □ □ □ ICH GCP E6 (R2) 4.5.1, 4.5.2 IU HRPP Policies: Research Personnel Responsibilities 2.3 Intervention & Outcomes Yes No N/A Not Reviewed REFERENCES
self-audit-tool-subject-chart-review.docx