1. Definitions
Subject : An individual who may participate in a clinical study.
Subject Database : A directory of subject contacts designed to help centers manage subject communications and contact information.
Subject contact information : Standard subject information fields provided by default by the Datacapt platform.
Subject personal information : Any additional custom questions directly created by the client (you).
Subject Database builder : An admin tool enabling the configuration of Subject Personal Information fields and endpoints.
Subject online personal account : A secure online account exclusively for subject use.
Subject creation online survey : A survey completed by a subject after creating their personal online account. The questions for this survey are configured in the Subject Database Builder.
Subject Platform ID: A unique code assigned to a subject across all modules. It is attached to the subject as a unique object, independent of any specific study.
Subject ID: A unique code for a subject within a specific EDC clinical study. This ID is generated when the subject object is linked to any clinical object (e.g., eCONSENT, eCRF, ePRO).
2. General informations
The Datacapt Subject Database module is designed to assist both centers and subjects by providing secure and efficient tools for managing subject contact and communication.
For Centers:
Collect and manage subjects’ personal information securely.
Manually create new subject contacts.
Manage a global contact list, filter contacts by criteria, and send targeted campaigns to potential participants.
Address GDPR and other local regulatory requirements.
For Subjects:
Apply online to the center’s contact database.
Create and use a secure online personal account.
Receive center communications.
Frequently Asked Questions
Must I contact the Datacapt team to add new Subject Personal Information fields to my Subject Database?
No. You are fully autonomous in designing and managing your workspace. However, the Datacapt team is available to provide advice and assist you during this process if needed.
Will I be 100% compliant with personal data regulations by default?
In a sense, yes. Datacapt provides a secure, GDPR-compliant platform built to manage contacts in a clinical environment. GDPR is one of the most stringent data protection regulations. However, you are responsible for defining roles, configuring access, establishing internal processes, and activating the compliance options available in the module.
Will I lose all the subjects data I’ve already collected in another solution?
No. We will assist you in migrating your subject information from your legacy system to Datacapt.
Can multiple users work in the system simultaneously?
Yes. Datacapt is built using modern web technologies, allowing multiple users to access the system simultaneously with fast query responses, regardless of the number of users or data points.
Can the solution manage subjects across multiple locations?
Yes. Datacapt supports multiple languages and centers within the same platform. Simply configure user access and translate any custom elements to get started.