ࡱ> _a^_ bjbj 085\5\OF F 8 dn$ZXmmmhZjZjZjZjZjZjZ$A]_jZ$mm$$ZZ$hZ$hZRhW@ : Policy and Procedure for Advarra, Inc. Protocol Submissions I. Policy A. Eastern Virginia Medical School (EVMS) has designated the Advarra, Inc. as a third EVMS IRB for investigators to use for review of studies involving human subjects. B. All costs associated with the submission and review of a protocol through Advarra is the responsibility of the Principal Investigator. (See Appendix 1 for fees.) If funds are not available to support the review, the EVMS investigator must use one of two in-house EVMS IRBs. C. EVMS IRB administration will determine if the protocol may be submitted to the Advarra. EVMS reserves the right to keep local level review for any submission. It is strongly recommended the site contact the EVMS IRB office before completing the Advarra forms. Local review will be required for certain studies. Examples are as those conducted in a local school setting; emergency research; emergency use of a product; studies involving a waiver of consent. This list is not inclusive and the site should contact the IRB office for an official determination. It may be necessary for the site to provide a copy of the protocol in order for a decision to be made on the use of Advarra services. II. Procedures A. Principal Investigator responsibilities: After determining if the principal investigator (PI) wants to utilize the services of the Advarra, Inc., the PI or their designee will: Prepare the Advarra electronic submission utilizing the Advarra CIRBI system. Advarra staff will assist the PI with questions regarding the proper completion of forms. Please Note: while research team members may prepare/enter the electronic submission in CIRBI, ONLY THE PI may make the actual submission. This electronic submission by the PI must occur by the time the below documents are sent to the EVMS IRB office. a. Complete the EVMS Submission Cover Sheet / Advarra Inc. (This form is only required for NEW submissions. Once Advarra approves a protocol, the investigator may submit amendments, continuing review and other study requests directly to Advarra.) b. Complete the Advarra Written Statement of IRB Oversight Waiver Submit materials to department chair for approval. Forward ALL completed documents to the EVMS IRB after signature. Ensures that the CTA for the study indicates that the sponsor or CRO will pay Advarra directly for IRB services rendered. EVMS will not handle pass through invoices for IRB services. Serves as the liaison between the Advarra IRB and the sponsor/CRO. Serves as the liaison between EVMS IRB office and the sponsor/CRO. B. EVMS IRB responsibilities: Designated EVMS IRB staff member(s): Upon receipt of Advarra submission, conducts administrative/facilitated review to occur within two business days. This review will determine if the request for Advarra review can be granted. If Advarra review is not approved, the site will be notified to submit the protocol to one of the EVMS IRBs, which will require completion of the EVMS IRB forms. In such cases, the PI may appeal the decision to the Assistant Dean for Human Subjects Protection. C. Advarra responsibilities: Work directly with the site to ensure the proper completion of all forms. Review submissions. Notify the EVMS IRB office and PI of any actions on the protocol. D. Adverse Event Reporting: The PI should send a copy of any local SAE reports to the EVMS IRB office at the same time as it is submitted to Advarra. Use of the EVMS SAE Submission form is required. E. Consent form: The Advarra has developed an EVMS model consent form. Sites must use this model consent for developing their study consents. Key EVMS IRB Personnel IRB Manager and the Assistant Dean for Research Subjects Protections.     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