The protocol or HRP-503 is missing information needed for the IRB to make required determinations (e.g. subject recruitment, data monitoring for compliance and safety and protections for participant privacy and confidentiality)
The consent form is missing, only the sponsor model consent is supplied, or the supplied consent does not contain information consistent with the UC Davis consent template.
For studies involving devices, the investigator or sponsor does not provide sufficient information for an IDE Exemption, Non-Significant Risk or Significant Risk Determination and there is no evidence that an IDE has been obtained.
A conflict of interest (COI) has been identified but no information about the COI is provided. The IRB must have sufficient information about the COI to make required determinations. This information is usually given to the IRB by providing the Forms 700U and 800.
Sections of the electronic Initial Review Application Form are not completed or marked Not Applicable (N/A) when the section is applicable.
For studies involving an investigational drug or biologic, the investigator brochure has not been provided; and for studies involving an approved drug, the investigational brochure or package insert is not provided.