Study Protocol (Beta)

Access to the interface is based on user accounts and roles to define permissions.

The following cosinuss° products can be connected to the study protocol:

• In-ear sensors with access to all raw data (including SpO2, pulse rate, PPG, acceleration data): cosinuss° One, cosinuss° Two, c-med° alpha

External devices:

• Polar H10 chest strap (including heart rate, heart rate intervals, raw ECG signal, raw acceleration data).

The study protocol can only be started if individually defined mandatory data has been entered in advance. In addition, the start of a recording sequence is only possible if all required devices are connected and Bluetooth data arrives.

Observations that have already been entered are marked as obsolete when corrected or reworked, but remain part of the log. The new or corrected observation replaces the obsolete observation.

The overview of the log shows the current status. In this way, it is easy to record which steps have already been completed at a particular point in time.

The data monitor clearly displays all vital signs from all connected devices.

Own comments can be entered into the protocol at any time and are part of the Case Report Form (CRF) as well as available in the API.

A basic validation of the entered vital signs takes place. For example, a warning message is generated if the reference temperature measurement shows a significant deviation from the measured temperature of the sensor.

A timer displays the current recording sequence as a countdown. The timer pauses automatically when the connection of one of the required Bluetooth devices is disconnected.

The stop button is used to end the recording sequence. This only happens when the entire time period of the sequence has elapsed (any disconnections are taken into account).

After the study is completed, a CRF can be downloaded as a PDF with all work steps and time stamps.

All data, log steps and events can be downloaded via the API.