The document describes various features of the ClinPlus CTMS clinical trial management system. It allows for easy navigation between screens that present summary information first with the ability to drill down for details. Role-based security restricts access to projects, sites, menus and features. Configuration can be defined at the system level but overridden at the project level. A combination of manual and automated tasks are used to ensure project steps are completed on time. Project messages, overviews, projections, events, charts, site events, visits, documents, blogs, payments to investigators, and financial overviews are described as key features to manage clinical research projects and metrics.

1. ClinPlus CTMSThe screens have been designed for easy navigation and consistency throughout the system. Easily move between the various areas with a click of the mouse. Most screens present summary information first, and allow the user to drill down for more detail.Access to projects, sites, menus and features is restricted using role-based security. The “My Favorites” feature allows users to add shortcuts to their most frequently used screens or reports onto the menu bar.

2. Configuration OptionsSystem configuration is easy for administrators and project managers. Default configuration choices are defined at the system level, but can easily be overridden at the project level.

3. Task ManagementA combination of manual and automated tasks is used to ensure that routine project steps are completed in a timely manner.Project MessagesCreate messages for team members to enhance project communication.

4. Project Management OverviewA high-level snapshot of the key metrics used to manage clinical research projects. This screen provides managers with the key numbers that are used to determine the progress of a clinical research study.

5. Project ProjectionsThe system will use the existing enrollment and site startup data to estimate project enrollment completion dates. In this example, the rate of enrollment would have to almost double (from 0.50 to 0.92 subjects/site month) in order to achieve an on-time completion.

6. Project EventsProject Events are used to track key milestones during the course of a clinical research project. Events are customized for each project.

7. Project ChartsCharts are used to visually demonstrate trends in project data, such as Enrollment, Screening, Site Initiations and Site Visits. Data Import is used to import project data from other systems, such as EDC or IVRS.

8. Site EventsStartup Events are used to manage the process of moving a Site through the various stages from Initial Contact through Site Initiation. Study Events maintain a history of key events during the study.

9. Site VisitsAll types of project-specific site visits can be tracked. Associated documents such as confirmation and follow-up letters and trip reports can be uploaded and shared with the project team.

10. Site DocumentsTrack the status of essential documents for each site. Optionally, sites or CRAs can upload electronic copies of each document to share with team members.

11. Integrated BlogsBlogs (or “Weblogs”) are used to manage and share communications, issues, or messages to all members of the project team. Blogs are available at the Project, Site, and Subject level, and can also include customizable Tags for easy searching and reporting. Team members can add comments to each blog entry.

12. Payments to InvestigatorsPayments to Investigators are calculated for each Subject Visit, and can be set for either manual or automatic approval. Multiple payment budget amounts can be defined for each Investigator based on the subject’s gender, group, or protocol amendment.

13. Financial OverviewFinancial overview screens display summaries of all key finance metrics, such as total payables, pending payments, and holdback amounts.