Common use of Monitor equipment Clause in Contracts

Monitor equipment. The equipment provided by the Promoter or CRO to the monitor must meet security measures and protection against external attacks: The hard drive must be encrypted. Must have an antivirus system installed, updated, operational and properly configured that will update the signatures daily. Must have installed a firewall correctly configured according to the security policy defined by the Promoter. Must have current operating system installed with the latest operating system updates. Must manage the Promoter's IT policies. Access must be protected by password or robust unlocking pattern. Must be a team dedicated exclusively to perform the tasks of the Trial on behalf of the Promoter. All services and connection interfaces that are not required must be disabled. The work profile configured on the computer for the Monitor must lack administration privileges, without these privileges hindering access to information systems. Obligations of the Monitor and the CRO in relation to the equipment: Should avoid installing and/or using applications that have not been formally approved by the Promoter. Must review and delete in an irretrievable way, periodically and in a maximum of 48 hours, the residual information that may have been stored in the equipment, such as temporary files or downloaded documents, data, etc. related to the monitoring tasks that you carry out in each moment. Once the work of the Trial on the Site's patient data management systems has been completed, the session must be closed against the remote access server. First of all check the connectivity of the equipment with the Site's URL: check if the Access Port provided by the Site can create a problem in the Promoter's network and that an exception has to be handled for the URL to pass the Promoter's firewalls. Monitor’s working environment: The workplace must meet minimum privacy requirements, such as in an enclosure with limited access (home), preventing other people from having access. If it is necessary to work from public access areas, additional protection measures must be taken to preserve the confidentiality of the information processed, including in any case the use of privacy filters on the screens of the devices. Work with paper-based information should be avoided and never proceed to its disposal without the use of safe mechanisms (paper shredder). Must work from encrypted networks, never from free wifi networks.

Monitor equipment. The equipment provided by the Promoter Sponsor or CRO to the monitor must meet security measures and protection against external attacks: The hard drive must be encrypted. Must have an antivirus system installed, updated, operational and properly configured that will update the signatures daily. Must have installed a firewall correctly configured according to the security policy defined by the PromoterSponsor. Must have current operating system installed with the latest operating system updates. Must manage the PromoterSponsor's IT policies. Access must be protected by password or robust unlocking pattern. Must be a team dedicated exclusively to perform the tasks of the Trial on behalf of the PromoterSponsor. All services and connection interfaces that are not required must be disabled. The work profile configured on the computer for the Monitor must lack administration privileges, without these privileges hindering access to information systems. Obligations of the Monitor and the CRO in relation to the equipment: Should avoid installing and/or using applications that have not been formally approved by the PromoterSponsor. Must review and delete in an irretrievable way, periodically and in a maximum of 48 hours, the residual information that may have been stored in the equipment, such as temporary files or downloaded documents, data, etc. related to the monitoring tasks that you carry out in each moment. Once the work of the Trial on the Site's patient data management systems has been completed, the session must be closed against the remote access server. First of all all, you should check the connectivity of the equipment with the Site's URL: check if the Access Port provided by the Site can create a problem in the PromoterSponsor's network and that an exception has to be handled for the URL to pass the PromoterSponsor's firewalls. Monitor’s working environment: The workplace must meet minimum privacy requirements, such as in an enclosure with limited access (home), preventing other people from having access. If it is necessary to work from public access areas, additional protection measures must be taken to preserve the confidentiality of the information processed, including in any case the use of privacy filters on the screens of the devices. Work with paper-based information should be avoided and never proceed to its disposal without the use of safe mechanisms (paper shredder). Must work from encrypted networks, never from free wifi networks.