eConsent replaces the paper consent form with a digital one that the subject signs and the investigator countersigns. This article defines the words the rest of the collection uses, explains what the module gives you, and answers the questions clients ask before they adopt it.
What the words mean
eConsent: electronic patient consent. A digital consent signed by the subject and countersigned by the investigator. It is equivalent to a traditional paper consent, and must be signed by an informed subject before they are included in a clinical study.
Subject: an individual who participates in a clinical study.
eConsent Form: the standard form your clinical staff create, for the subject to review and sign. This is the source form, which is later distributed to subjects.
eConsent Record: one eConsent attached to one subject, created from the corresponding eConsent Form.
đĄ Tip: the last two are the pair worth keeping straight. You build one Form, and it produces one Record per subject. When you edit, check which of the two you are looking at: changing the Form does not change Records that already exist.
What the module does
The eConsent module streamlines informed consent by letting subjects review, sign and manage their consent forms digitally. It keeps you aligned with regulatory standards while cutting paperwork. The main features are customizable templates, real-time tracking of consent status, support for multiple languages, and secure electronic signatures.
For investigators, it simplifies consent management, improves data accuracy, and gives real-time visibility into who has consented. Less administrative work, better documentation, and easier compliance monitoring, which leaves more time for running the study.
Frequently asked questions
Are eConsent and digital signatures compliant with GCP and local laws?
Are eConsent and digital signatures compliant with GCP and local laws?
Most countries now accept digital consent, but the specific requirements vary from one country to another. For the detail, see our guide.
Do I have to collect personal information to send an eConsent?
Do I have to collect personal information to send an eConsent?
Yes. To identify the subject, and to let them complete, sign and access a secure personal account, you need a first name, a last name and an email address. A phone number is optional.
How is data privacy ensured when collecting personal information?
How is data privacy ensured when collecting personal information?
Only limited personal information, the email address and optionally the phone number, is collected and stored in the Subjects module, which is entirely separate from clinical data. Access is restricted to authorized users, and personal information cannot be exported. Every access is logged and the data is encrypted. The system follows a privacy-by-default approach, protecting the data from the start rather than as an afterthought.
Can I use the eConsent module on its own, without an eCRF?
Can I use the eConsent module on its own, without an eCRF?
Yes. The eConsent module works independently. You can use Datacapt to digitize patient consents without an eCRF or any other component.
Can I design more than one eConsent for a study?
Can I design more than one eConsent for a study?
Yes, as many as your study needs, with support for more than 80 languages.
Can I send more than one eConsent to the same subject?
Can I send more than one eConsent to the same subject?
Yes. You can send several different eConsent forms to the same subject.