Definitions
eCONSENT (electronic Patient Consent) : A digital consent signed by subjects and countersigned by the investigator. A digital consent is equivalent to a traditional paper consent and must be signed by an informed and enlightened subject before their inclusion in a clinical study.
Subjects : An individual who participates in a clinical study.
eCONSENT Forms : A standard form created by clinical staff, designed for review and signature by the subject. This form serves as the source eCONSENT form that will later be distributed to subjects.
eCONSENT Records : An eCONSENT associated with a subject, created from the corresponding eCONSENT Form.
Discover more about
The eCONSENT module in Datacapt streamlines the informed consent process by allowing subjects to review, sign, and manage consent forms digitally. It ensures compliance with regulatory standards while improving efficiency and reducing paperwork. Key features include customizable templates, real-time tracking of consent status, multi-language support, and secure electronic signatures.
For investigators, the eCONSENT module simplifies consent management, improves data accuracy, and provides real-time visibility into subject participation. It reduces administrative workload, ensures better documentation, and enhances compliance monitoring, allowing investigators to focus more on study execution.
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. However, specific requirements may vary by country. To learn more, check our guide.
Must I collect personal information to address an eCONSENT to the participants?
Must I collect personal information to address an eCONSENT to the participants?
Yes, to identify, complete, sign and access a personnel secured account, a first name, last name, email and phone number (optional) must be collected.
How is data privacy ensured when collecting subject personal information?
How is data privacy ensured when collecting subject personal information?
Only limited personal information (email and/or phone number) is collected and stored in the “Subjects” module, which is completely separate from clinical data. Access is restricted to authorized users, and personal information cannot be exported. All access is logged, and data is encrypted to ensure privacy. The system follows a privacy-by-default approach, prioritizing data protection from the start.
Can I use Datacapt’s eCONSENT module alone without an eCRF?
Can I use Datacapt’s eCONSENT module alone without an eCRF?
Yes, the eCONSENT module is designed to function independently. You can use Datacapt to digitize patients consents without the need for an eCRF or additional components.
Can I design more than one eCONSENT for a study?
Can I design more than one eCONSENT for a study?
Yes, you can design as many consents as needed for your study, with support for more than 80 languages. The eCONSENT module is designed to address all requirements while being extremely flexible.
Can I send more than one eCONSENT to a participant?
Can I send more than one eCONSENT to a participant?
Yes, you can send multiple different eCONSENTs forms to a participant.