Features


The Clinical Trial website has a number of great features that will help you manage subject and sites better and get realtime insight in your study.

  • Easy site and subject management
  • Realtime reporting on enrollment and alerting
  • Full audit trail
  • Role based security
  • Subject enrollment

    Investigators can create, update, manage and report on subjects. Based on your protocol, the Clinical Trial website is configured to record the visit information and gather registration and additional information on a per-visit basis.

    Subject information

    When logging on, the investigator immediately has an overview on all subjects enrolled, both active and completed. From this screen with a single click, the investigator has an overview of a subject, including the most important information about this subject.

    Details recorded by default are:

    • Subject code
    • Site code
    • Time zone
    • Date of birth
    • Equipment in use
    • Visits + notes
    • Readings

    Next to this, all alerts generated about this subject are visible, as well as a full history of the equipment used by a subject.

    Subject management

    The website allows an investigator to review information and make changes where required. From making a small change to the date of birth, to reassigning equipment, tasks that the investigator is responsible for are directly accessible. And, if in doubt, a full help file is available from every page, including (optional) contact details from your support team.

    The clinical research team

    Getting realtime data into the website from all sites across the world makes your team respond quicker to anything happening in the field. Log on at the CRO interface and get an instant overview of all equipment, all sites and contact details. From there, you're just a click away from instant reporting based on live data.

    Reporting

    Basic reports include:

    • Subjects and alerts, organised per site
    • Alerts per subject
    • Equipment usage and allocation
    • Website usage per site
    • Subject completion status report

    When setting up the Clinical Trial website for your study, NetMedical can create several specific reports that you would like to have available realtime.

    All reporting is aspecific to subject data.

    Data submission

    Data submission usually generates larger dataset, which are in a specific format for your analysis systems. NetMedical therefore configures the data submission reports to your standards upon request. Upon data submission request, the NetMedical support team helps in the process of getting the submission file as well as analysing for data cleaning.

    Data point annotation

    One of the integrated features of the Clinical Trial website is data point annotation. On a per-reading basis, your team can anotate individual readings and mark them for exclusion from the data submission report. This process ensures that all data remains in the database, but only valid data ends up in the research reports.

    Automatic alerting

    Based on the inflowing readings, alert levels may be defined causing the Clinical Trial website to send out an alert to the responsible persons (to be defined by the protocol). There are also other alerts that the website may send out:

    • 3 days no readings received
    • trending alerts (like rolling 30-day average alerts)

    As part of the customisation NetMedical can implement whatever alert you can see sensible to support the clinical trial leader, the investigators or even the participants.

    Audit trails

    Integrated throughout the entire Clinical Trial website is the audit trail. You wont see anything on the surface, but underneath any action from investigator, from the clinical research team, from subjects, and even from the system itself, is recorded. This audit trail is organised on a per-subject, per-site basis and records any modification to the system, including the original state.

    Audit reporting

    The audit trail is accessible via the Audi Trail interface. This lets you review any record about any information change needed. Based on this audit trail NetMedical has provided report for studies in a few instances where an adverse event occurred and immediate analysis was demanded. Within a few hours the clinical team had a full report on all actions of investigators and subjects, on whether the subject was following protocol, whether everything was done to prevent the adverse event. In one case where a fatality was involved, the Clinical Trial website audit trail helped prove in a matter of hours that this was not related to the study. Imagine the efficiency and cost savings with that.