Point Trial Organization 4.3.1 Trial Organization The trial will be directed by the Principal Investigator, who will have ultimate responsibility for all activities and products of the trial, and will oversee all functions. The Co-Principal Investigator will assist with trial oversight and will substitute for the PI as necessary. The trial will take advantage of the proven skills of three major entities: the UCSF CCC, the NINDS NETT Network, and the POINT CRC. The NINDS NETT, through its Statistical and Data Management Center (SDMC), will provide statistical support and data management services, including reports to the DSMB and Clinician Event Coordinator, and shielding the UCSF CCC, NETT-CCC and POINT CRC from access to unblinded data during the performance of the trial. The Director of the NETT SDMC will be responsible for the randomization protocol, final statistical analysis plan and final data analysis. The Operations Committee (OC), chaired by the Principal Investigator, will oversee the entire performance of the trial. The OC will meet every week, with members outside San Francisco joining by teleconference. Membership of the OC is provided in the Manual of Procedures. Sanofi has agreed to contribute clopidogrel and its placebo at no cost and with no restrictions 4.4 Site Training, Certification, and Update Both the NETT and the CRC have already provided training to their sites in Good Clinical Practice Guidelines and in some outcome assessments (e.g., NIHSS, modified Rankin Scale). Online modules for training new sites are also available. Prior to initiation of subject enrollment, Site Investigators and Coordinators will complete online training programs and their certifications. In these training modules, the subject selection criteria and
Point Trial Organization 4.3.1 Trial Organization The trial will be directed by the Principal Investigator, who will have ultimate responsibility for all activities and products of the trial, and will oversee all functions. The Co-Principal Investigator will assist with trial oversight and will substitute for the PI as necessary. The trial will take advantage of the proven skills of three major entities: the UCSF CCC, the NINDS NETT Network, and the POINT CRC. The NINDS NETT, through its Statistical and Data Management Center (SDMC), will provide statistical support and data management services, including reports to the DSMB and Clinician Event Coordinator, and shielding the UCSF CCC, NETT-CCC and POINT CRC from access to unblinded data during the performance of the trial. The Director of the NETT SDMC will be responsible for the randomization protocol, final statistical analysis plan and final data analysis. The Operations Committee (OC), chaired by the Principal Investigator, will oversee the entire performance of the trial. The OC will meet every week, with members outside San Francisco joining by teleconference. Membership of the OC is provided in the Manual of Procedures. Sanofi has agreed to contribute clopidogrel and its placebo at no cost and with no restrictions 4.4 Site Training, Certification, and Update Both the NETT and the CRC have already provided training to their sites in Good Clinical Practice Guidelines and in some outcome assessments (e.g., NIHSS, modified Rankin Scale). Online modules for training new sites are also available. Prior to initiation of subject enrollment, Site Investigators and Coordinators will complete online training programs and their certifications. In these training modules, the subject selection criteria and
point_protocol_v6_0_tracked_changes_19mar2016.docx