The Embrace Research Portal is an ideal platform to collect data from different types of clinical and longitudinal research studies.
It serves as a multi-site management tool that allows you to run several independent Studies and manage many different Sites simultaneously. At the same time, you can gather physiological sensor data from your subjects and easily monitor their compliance without the need for repeated hospital visits, all in one centralized platform.
Depending on the specific configuration your organization has access to, you can have the possibility to download data collected by the Embrace2 watch. A list of custom events logged by the subjects can also be downloaded directly from the Research Portal.
Seizures, Autonomic Arousal, and Custom Events
Subjects enrolled in the Research Portal can log different types of events, depending on the initial setup of your Organization.
If you are running an Epilepsy study, you can have Seizure Events logging activated for your Organization.
You may also run an Autonomic Arousal study, where Embrace2 automatically detects your subjects’ “stress” events. One of the useful signals for monitoring the Autonomic Nervous System (ANS) is Electrodermal Activity (EDA), an umbrella term for all of the skin’s electrical phenomena. The most prominent component of EDA is the activity of the sweat glands which, in addition to responding to changes in body temperature, also respond to various psychological and emotional stimuli. Stress is a complex physiological phenomenon, but the component that the study will focus on is the response elicited by the Sympathetic Nervous System (SNS), a subset of the ANS. This reflects strong emotional states such as fear, anxiety, anger, and positive excitement. The autonomic arousal events detected by Embrace2 will be listed in the Research Portal with the date, time, and duration of the event.
For non Epilepsy-related or a generic data collection study, you can have Custom Events logging activated for your Organization. Custom Events can be any occurrence that your subject experiences during the clinical trial period and can be set entirely by you. This can be a migraine, stressful event, panic attack, pain, asthma attack, etc.
Depending on the study, subjects will be logging seizures, autonomic arousal, or custom events through the Mate App. Subjects can log date and time, duration, and a brief description of the event. You can download the events logged by the Subjects in the form of a Seizure/Autonomic Arousal/Custom Event Report in .csv format from the Research Portal.
Study permissions and hierarchy
The Research Portal provides 3 different levels of information for your research team members - Organization, Study, and Site. The organization is the top level, where you can build your research team and check the status of your Studies at a glance. You can create and organize new Studies with their own dedicated teams. Within the Study, you can then add as many Sites as you see fit to support your study. You can find more information on how to set up your organization here: Setting up the Research Portal
The default type of organization configuration is the Pilot Study, in which an Organization Owner will be assigned to allow full control and management of all levels of the organization. The owner has permission to perform all types of actions. They can invite or revoke access to other team members, view and download data (when the feature is enabled by Empatica), and enroll and complete subjects at all levels. Moreover, the owner is the only one who can enable and disable raw data download permissions to the team members (if raw data download is included in the configuration).
Each member of the research team can be assigned permissions that give them access as you deem appropriate. There are 2 types of roles that you can choose from, which will be assigned when inviting the research team member to join the investigation at the Organization, Study, or Site level.
- Manager access - viewer access, can add or remove team members, create new studies (if on the Organization level) or sites (if on the Study level), and subject management
- Viewer access - viewing permission on the invited level and any subordinate levels (if any)
When inviting a research team member to a level, please note that the member cannot access a level higher up (i.e., from Site to Study, or from Site to Organization). However, the configuration allows them to access from top down (i.e., members who have Study permissions can access the Sites within).
If you need stricter permissions and hierarchy, please feel free to consult the Empatica Sales Team at firstname.lastname@example.org.