Safety Related Event Reporting. A Data Safety Monitoring Board (“DSMB”) will be established for the Study. The safety monitoring plan for Study Drug will be agreed upon by both Parties and CRO. CRO will require Site Principal Investigator to report all AEs to the applicable IRB, CRO Protocol Sponsor, and Study Drug Sponsor at: xxxxx@xxxxxxxxxx.xxx in accordance with the Protocol. CRO will be responsible for the reporting and tracking of all AEs in compliance with all Applicable Laws, requirements imposed by the IRB, and the Protocol. HJF will be responsible for distributing aggregated DSMB safety reports.
Safety Related Event Reporting. Institution shall immediately, but no later than ten (10) days after the event comes to the knowledge of Institution, report all Serious Adverse Events to Sponsor and the IRB.
