Functions
ClinStream™ 2.6 ensures quality data from the point of entry and delivers the full advantages of speed, efficiency and cost effectiveness through use of its unique support modules:
> Study Executive Committee: Accessible to the Sponsor and Syreon personnel involved in the day to day management of the study, this provides access to timelines and milestones, the Project Plan, the Roles and Responsibilities document and agendas and Minutes for teleconference and upcoming meetings.
> Scientific Advisory Committee / Data Review Board: Accessible only to members of the Scientific Advisory Committee or Data Safety Committee (as applicable in each study) and Syreon personnel, this link contains meeting schedules, agendas and meetings, minutes and access to selected secure data reports.
> Study Module: the "home" page of all Syreon study web sites provides an immediate and dynamic overview of study conduct and progress, with key study dates and continuous updates of study-related events and a real-time reporting of subject recruitment.
> Site Module: provides a detailed list of participating sites and contact details, along with comprehensive study support, on-line GCP training materials, study personnel and remote training, certification and evaluation.
> Document Module: maintains all study documents in electronic format for easy navigation and retrieval. Amendments and updates are posted immediately, avoiding the problems of printing, distribution and outdated paper copies.
> Data Module: contains eCRFs for subject enrolment, randomization, clinical data entry, queries and correction, with sophisticated on-line checks to detect omissions and errors at the point of entry.
> Report Module: allows real-time monitoring of study metrics and individual or aggregate clinical data reports to track study operation, protocol compliance, and data quality and completeness.
> Support Module: provides on-line tools and information to support Investigators during the conduct of the study, including the ability to change passwords and trouble-shoot browser problems and links of interest for the disease area under study, as well as the Sponsor's home page.