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