Protocol Approval Criteria 1 Risks to subjects are

Protocol Approval Criteria 1. Risks to subjects are minimized Provisional Approvals Limited to the Following: 1. 2. Risks to subjects are reasonable in relation to anticipated benefits and knowledge to be gained is important • Study documents • Recruitment materials 3. Selection of subjects is equitable 4. Informed consent will be sought • The application 2. Minor prescribed processes or procedures that are decided upon by the convened IRB and are required to be implemented in order for approval to be granted. • For example: The requirement to implement a specific process for distributing recruitment materials in the clinic that MUST be adopted by the study team as a part of the application in order to receive approval. 3. Confirmation by the study team, for the record , that the IRB’s collective understanding of a point is indeed correct, with the definite caveat that if the IRB’s stated understanding cannot be fully confirmed the study MUST be reconsidered by the convened IRB before full approval can be granted. 5. Informed consent will be appropriately documented 6. Appropriate monitoring the data collected to ensure the safety of subjects 7. Adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data 8. Additional safeguards have been included in the study to protect the rights and welfare of vulnerable subjects Minor prescribed edits to in order to correct errors identified by the IRB. Edits can be required for:

Safety Events (Deviations, UAPs, Non-Compliance) • Is the problem clearly described in the submission? • Can the ultimate cause(s) of the problem be determined? • Does the problem result from, or constitute, serious non-compliance on the part of the study team or any other HRPP component? • Does the problem result from, or constitute, continuing non-compliance on the part of the study team or any other HRPP component? • Is the corrective action plan clearly described? • Is the corrective action plan appropriate and adequate to minimize the risk of similar problems in the future? The IRB must make a finding regarding whether a deviation, UAP, or non-compliance was SERIOUS or CONTINUING non-compliance ICH-GCP Review Checklist for Discussion: Principal Investigator • Did the PI provide a copy of their CV or other documentation providing evidence of their qualifications? Consent • For alternative procedures or treatments that may be available to the participant, are the important potential risks and benefits explained? • Does the consent state that monitors, auditors, IRB, or other regulatory agencies will be granted direct access to the participant’s original medical record for verification of clinical trial procedures or data, without violating confidentiality of the participant and to the extent permitted by other applicable laws? • Does the consent provide a place for participants to indicate if they would like records shared with their primary physician? Clinical Trials • Has the study team attested that they have read and agree to follow the investigator’s responsibilities found in e. IRB?