The Subject Database is your center's contact directory: the people who might take part in a study, held in one place and independently of any single study. This article defines the words the rest of this collection uses, and answers the questions clients ask before they start.
What the words mean
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: the standard subject information fields provided by default by the Datacapt platform.
Subject personal information: any additional custom questions you create yourself.
Subject Database Builder: an admin tool for configuring 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. Its questions 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 one specific EDC clinical study. It is generated when the subject object is linked to any clinical object (eConsent, eCRF, ePRO).
đĄ Tip: the last two are the pair people confuse. A subject has one Subject Platform ID for life, across every module. They then get a separate Subject ID in each EDC study they join. If an ID does not match between two screens, check which of the two you are looking at before anything else.
What centers can do
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.
What subjects can do
Apply online to the center's contact database.
Create and use a secure online personal account.
Receive center communications.
Frequently asked questions
Do I need to contact Datacapt to add new Subject Personal Information fields?
Do I need to contact Datacapt to add new Subject Personal Information fields?
No. You are fully autonomous in designing and managing your workspace. The Datacapt team is available to advise and assist you during the process if you want it.
Will I be compliant with personal data regulations by default?
Will I be 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, and GDPR is one of the most stringent data protection regulations there is. You remain responsible for defining roles, configuring access, establishing internal processes, and activating the compliance options available in the module.
Will I lose the subject data I have already collected in another solution?
Will I lose the subject data I have already collected in another solution?
No. We will assist you in migrating your subject information from your legacy system to Datacapt.
Can several users work in the system at the same time?
Can several users work in the system at the same time?
Yes. Datacapt is built on modern web technologies, so multiple users can work at once with fast query responses, whatever the number of users or data points.
Can the solution manage subjects across several locations?
Can the solution manage subjects across several locations?
Yes. Datacapt supports multiple languages and centers within the same platform. Configure user access and translate any custom elements to get started.