Sensivo is a cloud-based, privacy first solution for clinical researchers. This allows researchers to store their data within a flexible, collaborative spreadsheet that was built from the ground up around GDPR.
Why should I use Sensivo for my clinical research data storage needs?
With the possibility of sizable fines for non-compliance of the GDPR it is imperative institutions work to find a compliant system. Additionally, Sensivo’s data entry optimization increases efficiency of clinical researchers - eliminating the need for an outside support for system or database changes.
How does Sensivo differentiate itself from other clinical research solutions?
On top of being built around GDPR, Sensivo separates itself by utilizing the spreadsheet view. Many, if not all other solutions, use a case report form (CRF).
Why should my team stop using Excel?
Storing sensitive research data in Excel is not secure nor compliant with privacy regulations. Additionally, Excel does not support collaboration needs of modern clinical researchers. Using a cloud-based spreadsheet, like Sensivo, allows for full degree of collaboration and traceability across institutions and borders
When switching from Excel to Sensivo, what functionalities, if any, will we be losing?
The only main function you will be losing is the ability to perform data analysis, but we make it hassle-free to export your data to external statistical software.
How it works
My research team is interested in using Sensivo, how do we get started?
Sensivo is in the beta-testing stage with our research partners, so it is currently open on an invite-only basis.
Can I import already existing research data to Sensivo?
Yes, to begin using Sensivo, your team can either upload their already existing .xls formatted research database to the system, or they can start a database from scratch by manually inserting their data.
Can I assign specific roles or permissions to my research team?
Yes, the admin is in charge of user management for each database and gives his/her team members appropriate roles. Sensivo offers 4 types of roles:
Admin - you have authority over the project. You are able to act as a data-editor, assign member roles, and export data out of the system.
Data-editor - you can make edits to the data set such as adding a research subject or a new parameter.
Viewer - you are unable to make any changes to the data. You can only view the data.
Limited-access - you are only able to view the data. These viewing abilities are granted for a limited time set by the admin.
How many researchers can I add to my project?
You can add as many researchers as you need to the project - there is no limit!
Is it secure to access data sets from home through Sensivo?
Yes, if you have a browser and internet, you can access your research data from anywhere.
Can I export my data from Sensivo to statistical software, like Stata, RStudio, or SPSS?
Yes, Sensivo allows for data exportation. Although, only users with exporting rights can export data from the system.
Is there a demo version of Sensivo?
Yes, if you are wanting to test out the system, reach out to us at email@example.com; we will set up a demo version for you.
How are GDPR and clinical research connected?
The General Data Protection Regulation (GDPR) states that processing personal data concerning health, genetics or biometrics shall be prohibited. Although, according to Article 9, processing this sensitive data is permitted when the purpose lies within the field of research. Within this exemption, clinical researchers must still respect the essence of the GDPR by taking specific measures to safeguard the interests of the data subject.
My research team is not physically within the EU; do we still need to comply with GDPR?
If your research takes place out of the EU, but involves EU citizens’ personal data, then yes, you must comply. Although, many countries outside of the EU are starting to adopt regulations similar to GDPR, so you will more than likely have to make adjustments in the near future.
What happens if my organization is not GDPR compliant?
If you are not GDPR compliant, you could be fined up to 4% of your annual global turnover or €20 million - whichever is larger.
Is Google Sheets or Office 365 GDPR-compliant?
No, they are not GDPR-compliant.
Privacy and Security
How is Sensivo GDPR compliant and protective of sensitive, personal data?
Below are the several steps Sensivo has taken in order to protect sensitive, personal data:
Every connection to your cloud account is encrypted through SSL.
Our system keeps all data sets in a unique database, making sure no one else has access to your data.
All data is stored on highly-secured servers in Sweden, or within the European Union.
Sensivo uses pseudonyms for subject names. Personal information and corresponding genetic and health data are stored on separate servers for improved security. Data on both servers are encrypted and require an encryption key which stores on the client side
Users log into the service through a 2-step authentication process.
No Sensivo employee can access your data without specific permission
Each subject has the right to be forgotten and the right to request a copy of any personal data stored in their regard.