BARDA Protocol Review Process Before Patient Enrollment Sample Clauses

BARDA Protocol Review Process Before Patient Enrollment. Begins The COR has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore, before patient accrual or participant enrollment, the Contractor must ensure the following (as applicable) are in place at each participating institution, prior to patient accrual or enrollment: ● IRB- or IEC-approved clinical research protocol identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria. ● Documentation of IRB or IEC approval, including OHRP federal wide number, IRB or IEC registration number, and IRB and IEC name. ● IRB- or IEC- approved informed consent document, identified by version number, date, or both and dates it is valid. ● Plans for the management of side effects. ● Procedures for assessing and reporting adverse events. ● Plans for data and safety monitoring (see above) and monitoring of the clinical study site, pharmacy, and laboratory. ● Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received training in the protection of human subjects. Documentation to demonstrate that each of the above items are in place shall be submitted to the COR) for evaluation and comment in conjunction with the protocol. Execution of clinical studies requires written authorization from the COR in accordance with this Section of this contract. Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Mediwound Ltd.
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