Informed consent is at the heart of any study, as it ensures strong scientific methodology, patient’s safety and confidentiality.

In observational research, patients are consenting to the use of their data for research – as opposed to consenting to take an investigational treatment. Their standard of care should not be disrupted. For this reason, it is important to enable remote consenting.

Remote eConsent allows for equivalent confirmation of paper consent to be achieved through the surrounding workflow that a patient must go through. Security and audit information is embedded in it.

Cisiv’s eConsent module allows for patients to remotely consent to their participation in the study via the web or the Baseline patient app. This can enable a study to happen around the needs of the patient. The eConsent module is 21 CFR Part 11 compliant and is fully integrated with Baseline Plus’ other features including EDC, ePRO, and eCOA.

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