Extract to table

In the event of any dispute, controversy, or claim arising out of or relating to the MCTA, the designated senior representatives of each party shall first attempt to resolve such dispute through good-faith negotiation for a period of thirty (30) days following written notice of the dispute

Penterra must ensure timely renewal of such policy and delivery of updated certificates of insurance to Veridian annually throughout the duration of the CLARION Trial

Each participating site must maintain active IRB approval throughout the duration of the CLARION Trial

IRB continuing review submissions must be filed no later than the applicable anniversary date of the initial IRB approval for each site

These forms must be updated as investigators are added or replaced and must be maintained in the regulatory trial master file

2 of the MCTA and applicable FDA regulations, site records, including but not limited to source documents, case report forms, informed consent documents, IRB correspondence, and drug accountability records, must be retained for a minimum of fifteen (15) years following the completion or termination of the CLARION Trial