The Survey Management system facilitates the distribution of surveys to contacts associated with patients in the Rett Syndrome Patient Registry. To meet regulatory requirements, it includes a mechanism that guarantees surveys are answered by the designated contact, ensuring the integrity of the data collected.
Survey Creation
Surveys are created by administrators to collect data over time, such as health updates or new genetic information.
Surveys can cover a wide range of topics and are designed to collect longitudinal data that can be linked to specific patients.
Patient Targeting
Administrators can select a subset of patients from the master database to receive specific surveys.
The system allows filtering based on criteria such as age, mutation type, or previous survey responses.
Private Area for Survey Access
Surveys are accessed through a private area where users must authenticate.
Each contact associated with a patient will log in to their private area to view and complete any assigned surveys.
Contact Authentication and Verification
To comply with regulatory requirements, the system includes a mechanism to verify that the survey is completed by the designated contact:
Authentication:
Contacts are required to authenticate themselves before accessing their private area where surveys are available. Authentication may include email verification and a passwordless login or a similar secure method.
Two-Factor Authentication (2FA):
Before completing the survey, the contact may be required to verify their identity using a second factor of authentication (2FA), such as an SMS code or authentication app.
This ensures that only the authorized contact can access and complete the survey.
Audit Trail:
The system records a detailed audit trail for each survey submission, including the identity of the contact who submitted the survey, the timestamp, and any authentication steps completed.
This guarantees compliance with regulatory requirements and provides accountability for the data submitted.
Consent Confirmation:
Each contact must confirm their consent before submitting the survey, ensuring compliance with privacy regulations such as GDPR.
Survey Response Processing
Once the survey is submitted, the response is securely stored in the database.
Each response is linked to the corresponding patient, enabling longitudinal tracking of the patient’s condition or genetic information.
Data is stored securely and is accessible only to authorized administrators.
Data Security and Privacy
All survey responses are encrypted both in transit and at rest.
The system adheres to GDPR and other regulatory requirements for data protection, ensuring that sensitive patient and contact information is handled with care.
Contact authentication ensures that responses are submitted only by verified individuals, protecting the integrity of the collected data.