Clinical Ink

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Clinical Ink™ Features

Clinical Ink's innovative SureSource™ eSource solution employs a client running on tablet PCs and a web portal accessible to any computer connected to the Internet.

SureSource™ — Tablet

SureSource™'s client allows source data to be captured both securely and intuitively.

 

ChartRoom™ Access to source data is securely controlled via our ChartRoom™. Before a source document can be modified, it must be checked out and downloaded to a single tablet. When completed, the document is returned to the SureSource portal. Source documents can be downloaded individually or in batches, by simply dragging and dropping the chart icon. All data remains under the Investigator's control and the possibility of conflicting versions is eliminated.

Subject Chart SureSource™'s visit documents and Medical History, AE and Conmed logs are grouped together in a Subject Chart, providing a quick overview of subject progress, recruitment source and visit status. The workflow and document organization is immediately familiar to site personnel, minimizing confusion and reducing training requirements.

Visit Documents SureSource™ documents retain the look and feel of traditional paper source documents. Unlike paper, however, our SureSource™ documents capture both structured and unstructured data (machine readable, human readable), verify data at the time of capture and control user access to specific pages (physical exam, for example). SureSource™ combines the easy familiarity of paper source with the powerful intelligence and enhanced security of digital systems.

Document Validation Upon saving a visit form, the Validation screen displays all data that is incomplete or out of range. Selecting an item allows you to correct the information or assign the item to another user. SureSource™ reduces the risk of tasks being overlooked and shortens the time required to complete them. All data is verified at the time of capture instead of days or weeks later.

InkNotes™ Coordinators and Investigators need a way to record notes on-the-fly. Writing a note using InkNotes is an easy, two-step process: tap the Note icon and write your note. Unlike the sticky notes that plaster traditional charts, InkNotes are secure, private and always available.

Medical History, AE & Conmed The Medical History, AE and Conmed logs allow you to review cumulative logs and record new entries. Entering Medical History, AE's and medicatons, using both user-friendly descriptions and standard medical nomenclature, is fast and accurate. Investigators are able to quickly review entries and sign the logs.

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SureSource™ — Web Portal

Since all source data is securely stored in a central data repository, it is available to authorized personnel anytime from anywhere in the world, while remaining under the control of the Investigator.

 

Study Overview Sponsor personnel with proper authority can login to SureSource™, select a study and particular research site. The Study Overview provides a quick view of site statistics, including personnel, number of subjects, query status, recruitment source and site progress.

Subject Chart The Subject Chart view provides all the information pertaining to a given subject, including: recruitment source, visit status and Med Hx, AE and Conmed logs. Monitors can easily review subject and site progress and address potential problems before they lead to costly delays.

Source Documents SureSource™ documents can be viewed online, including marginal notes, explanations, diagrams, etc. Remotely reviewing the actual source documents reduces monitor travel and allows them to spend their time onsite more productively.

Query Center Although SureSource™ eliminates the majority of queries, we include an intuitive query management tool for those that remain. Monitors can easily add queries to documents or specific data fields. Once created, the coordinators receive a message that a new query has been entered. The Query Center displays both the original query and coordinator's response as well as the query status in one window.

Message Center With SureSource™'s communication system, sending a message to a member of the study team is a simple, secure process. The message itself does not leave our data center, instead an email is sent to the recipient announcing that they have a new message with a link that takes them to the SureSource portal.

Audit Trail SureSource™ captures all user activity, on both the tablet and the portal, in an audit trail. Data entry, changes, additions, and the user who made them are recorded. The audit trail can be filtered by study, site, user, subject and date providing a detailed view of study data.

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