Incomplete Submission Documents: Please refer to the submission form to ensure you are submitting all required documents for the review of new studies and additional sites. Study Placed Missing Key Information: The IRB may identify areas of concern with the protocol and defer approval of a study or require modifications as part of the approval. Delays in Finalization of ICF: After formal IRB review, additional Advarra-internal or sponsor/CRO/institution review of the ICF may be required prior to finalization. Approval documents will not be sent to sites until the ICF is finalized. IRB Concerns With Site Submission Information: Upon review of additional sites conducting a previously approved protocol, the IRB may note an area of concern with the site’s responses on the submission documents. If concerns are noted or the compensation for participation information is unclear, an Advarra representative will contact the site. The site must provide satisfactory resolution of the identified issues before the approval process can be completed. Site-Specific ICF Revisions: If a site submits a request for additional site-specific revisions, an IRB member must review the requested revisions to determine their appropriateness. In some instances, approval from the sponsor/CRO may also be required.