Chart Room Access to source data is securely controlled via the Chart Room. Before a source document can be modified, it must be checked out and downloaded to a single tablet PC. When completed, the document is returned to the central repository. Source documents can be downloaded individually or in batches, by simply dragging and dropping the chart icon. With Clinical Ink, all data remains under the Investigator's control and the possibility of conflicting versions is eliminated.

Subject Chart Clinical Ink's visit forms and Adverse Event/Concomitant Medication (AE/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 Forms Visit forms retain the look and feel of traditional paper source documents. Unlike paper, however, Clinical Ink's source documents capture both structured and unstructured data (machine readable, human readable), verify data at the time of capture and control access to specific pages (physical exam, for example). Clinical Ink combines the easy familiarity of paper source with the powerful intelligence and enhanced security of digital systems.

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

AE & Conmed Logs The AE and Conmed logs, accessible from the Subject Chart and within any Visit form, allow you to review cumulative logs and record new entries. Entering AE's and Medications, using standard nomenclature and codes, is fast and accurate with Clinical Ink's comprehensive, easy to navigate lists.

Validation and Changes 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. Clinical Ink reduces the risk of tasks being overlooked and shortens the time required to complete them.

When changes are made to a previously saved form, Clinical Ink captures the change, who made it and the reason. This information is available for review in our comprehensive Audit Trail.

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

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

Visit Forms All Visit forms that have been saved can be viewed online, even if they are currently checked out. Since the forms are presented as pdf files, the actual source document can be viewed, including marginal notes, explanations, diagrams, etc. Reviewing the actual source document allows monitors to answer questions without initiating formal queries, saving both time and money.

When there is more than one version of a Visit form, Clinical Ink allows them to be examined in one of two ways: either by opening them up individually or, if a detailed comparison is needed, by using the Historical Comparison feature. In the latter case, simply clicking on the versions to be compared displays all the data fields in a table, allowing you to quickly see which fields have been changed, by whom and why. Having remote access to source data allows monitors and data managers to accelerate the data collection process.

Message Center With Clinical Ink's Quick Note feature, sending a quick message to the coordinator or investigator is a simple process. Select Note, choose the recipient from the drop-down list, write your message and click Send. The note is sent and a link to the form in question is included. Fast, focused communication between site personnel and monitoring staff assures that clean data is available as quickly as possible.

Administration Center Clinical Ink's Administration Center allows the designated site administrator to enter the names, email addresses and passwords for the site personnel assigned to a study. All permissions are role-based and can be quickly modified by the administrator. The Administration Center provides fast, intuitive and secure control of the access to source data.