As part of ClinSmart’s concept for virtual/decentralised trials we are developing a process for eConsent in convenience for the patients.
ClinSmart is developing a validated process to enable eConsent in clinical studies to ensure compliance with all regulations, including Good Automated Manufacturing Practice 5 (GAMP5).
The information about the study can be shared with the patient by recorded videos and/or digitalised documents, pictures and instructions through validated software. The investigator can also inform about the study in a telephone or video meeting.
Informed consent process
The Informed Consent Form is shared with the patient via a safe link in an e-mail or text message.
To ensure GCP compliance the patient must have an opportunity to ask questions about the study and the investigator has to evaluate the patients understanding of the information and consent – this can be done by a telephone or video meeting.
Signing of eConsent
Both the patient and the investigator sign the consent form digitally using Bank-ID. A receipt with a time stamp is generated.
The signed consent form can be downloaded for the patient to save.