Common use of Status Reporting Clause in Contracts

Status Reporting. The Medpace Senior CTM will serve as the central channel for communication between Medpace and VIVUS. The OB-302 CTM will work in conjunction with the clinical monitoring group to track study progress and report to VIVUS on a weekly basis. In addition, the OB-302 CTM will be responsible for overall management of site information, overseeing the status of Investigator contracts, direct supervision of CRAs, tracking of enrollment information, and distribution of study supplies. The Medpace OB-302 CTM will be the primary contact for the sites to address protocol interpretations and inclusion/exclusion criteria. All protocol-related issues will be recorded in an ongoing document to ensure consistency. The CTM is available 24 hours a day, 7 days a week via the Medpace Project Helpline. Medpace will develop a communication plan at the start-up of the study. The CTM will work with the VIVUS project team to define details regarding study communication, including status reporting and team conference calls. Medpace typically deliver status reports on a predetermined day (and time) of the week, which is established around the weekly team calls so that the information can be discussed. Utilization of IVRS will also allow the project team to review patient status on a real time basis. The Medpace CTM will collaborate with the Medpace Medical Expert and the VIVUS Study Manager to address any questions that may arise. The ClinTrak Study Management databases will serve as the primary source of project status information and will allow the Medpace CTM to report on any aspect of the study. The databases are updated on a real-time basis, providing accurate and up-to-date information. Elements of ClinTrak include: · Phone contacts; · Monitoring visit reports; · Patient status including details on withdrawals during the treatment phase; · Study supplies; and · Protocol deviations. Medpace will provide weekly status reports via a secure project website, to include the following status by site: · Number of patients screened; · Number of screen failures; · Number of patients randomized; · Number of patients dropped with drop rates; and · Number of patients completed. In addition, monthly reports will be provided, to include the following: · Monitoring visits scheduled; and · Monitoring visits completed. Data Management status reports will be provided monthly via a secure website. These reports will include the following: · Cumulative and interval eCRF status by site (including number of eCRFs transmitted and cleaned); · Cumulative and interval patient status by site (including number of patients ongoing, completed, and early terminations) based on eCRF data in-house; and · Cumulative and interval query status by site (including number of queries issued and days outstanding).

Status Reporting. The Medpace Senior CTM will serve as the central channel for communication between Medpace and VIVUS. The OB-302 OB-303 CTM will work in conjunction with the clinical monitoring group to track study progress and report to VIVUS on a weekly basis. In addition, the OB-302 OB-303 CTM will be responsible for overall management of site information, overseeing the status of Investigator contracts, direct supervision of CRAs, tracking of enrollment information, and distribution of study supplies. The Medpace OB-302 OB-303 CTM will be the primary contact for the sites to address protocol interpretations and inclusion/exclusion criteria. All protocol-related issues will be recorded in an ongoing document to ensure consistency. The CTM is available 24 hours a day, 7 days a week via the Medpace Project Helpline. Medpace will develop a communication plan at the start-up of the study. The Senior CTM will work with the VIVUS project team to define details regarding study communication, including status reporting and team conference calls. Medpace typically deliver delivers status reports on a predetermined day (and time) of the week, which is established around the weekly team calls so that the information can be discussed. Utilization of IVRS will also allow the project team to review patient status on a real time basis. The Medpace CTM will collaborate with the Medpace Medical Expert and the VIVUS Study Manager Clinical Leader to address any questions that may arise. The ClinTrak Study Management databases will serve as the primary source of project status information and will allow the Medpace CTM to report on any aspect of the study. The databases are updated on a real-time basis, providing accurate and up-to-date information. Elements of ClinTrak include: · Phone contacts; · Monitoring visit reports; · Patient status including details on withdrawals during the treatment phase; · Study supplies; and · Protocol deviations. Medpace will provide weekly status reports via a secure project website, to include the following status by site: · Number of patients screened; · Number of screen failures; · Number of patients randomized; · Number of patients dropped with drop rates; and · Number of patients completed. In addition, monthly reports will be provided, to include the following: · Monitoring visits scheduled; and · Monitoring visits completed. Data Management status reports will be provided monthly via a secure website. These reports will include the following: · Cumulative and interval eCRF status by site (including number of eCRFs transmitted and cleaned); · Cumulative and interval patient status by site (including number of patients ongoing, completed, and early terminations) based on eCRF data in-house; and · Cumulative and interval query status by site (including number of queries issued and days outstanding).

Status Reporting. The Medpace Senior CTM will serve as the central channel for communication between Medpace and VIVUS. The OB-302 OB-301 CTM will work in conjunction with the clinical monitoring group to track study progress and report to VIVUS on a weekly basis. In addition, the OB-302 OB-301 CTM will be responsible for overall management of site information, overseeing the status of Investigator contracts, direct supervision of CRAs, tracking of enrollment information, and distribution of study supplies. The Medpace OB-302 OB-301 CTM will be the primary contact for the sites to address protocol interpretations and inclusion/exclusion criteria. All protocol-related issues will be recorded in an ongoing document to ensure consistency. The CTM is available 24 hours a day, 7 days a week via the Medpace Project Helpline. Medpace will develop a communication plan at the start-up of the study. The CTM will work with the VIVUS project team to define details regarding study communication, including status reporting and team conference calls. Medpace typically deliver delivers status reports on a predetermined day (and time) of the week, which is established around the weekly team calls so that the information can be discussed. Utilization of IVRS will also allow the project team to review patient status on a real time basis. The Medpace CTM will collaborate with the Medpace Medical Expert and the VIVUS Study Manager to address any questions that may arise. The ClinTrak Study Management databases will serve as the primary source of project status information and will allow the Medpace CTM to report on any aspect of the study. The databases are updated on a real-time basis, providing accurate and up-to-date information. Elements of ClinTrak include: · Phone contacts; · Monitoring visit reports; · Patient status including details on withdrawals during the treatment phase; · Study supplies; and · Protocol deviations. Medpace will provide weekly status reports via a secure project website, to include the following status by site: · Number of patients screened; · Number of screen failures; · Number of patients randomized; · Number of patients dropped with drop rates; and · Number of patients completed. In addition, monthly reports will be provided, to include the following: · Monitoring visits scheduled; and · Monitoring visits completed. Data Management status reports will be provided monthly via a secure website. These reports will include the following: · Cumulative and interval eCRF status by site (including number of eCRFs transmitted and cleaned); · Cumulative and interval patient status by site (including number of patients ongoing, completed, and early terminations) based on eCRF data in-house; and · Cumulative and interval query status by site (including number of queries issued and days outstanding).