e-ICF
Informed Consent Form
e-FORM includes two main features that directly involve patients in clinical studies:
An e-ICF (Informed Consent Form) provides study participants with the information needed to make an autonomous
and informed decision about participating in a clinical study.
Key features of the e-ICF:
- It provides the same information as a paper informed consent form but in an electronic format, potentially including multimedia.
- It can be used to supplement or replace paper-based informed consent processes. Participants can choose to use paper or electronic methods for informed consent, in whole or in part.
- The consent process can occur at the study site or remotely. If it takes place remotely, the system must ensure that the person who electronically signs the consent is the actual participant.
- It enables participants to give their consent from home.
- It allows participants to reflect more calmly before granting or withdrawing consent.
- Presenting information in multimedia formats offers greater support for decision-making.
- Once the consent is completed, the data is immediately available for viewing and analysis.
- To further ensure security, an OTP (One Time Password) mechanism can be implemented to verify the subject's identity.
- The Informed Consent can can be produced in PDF form and digitally, electronically or manually signed by the patient.
- Informed consent (e-ICF) can only be granted/revoked if specific conditions are met in the correct sequence: verification of the subject's identity, reading and confirmation of the "Terms and Conditions," and reading and confirmation of the "Information Sheet".
Granting consent allows the system to activate all questionnaires required by the protocol, while withdrawing consent blocks the study forms under the investigator's responsibility
.