Sign on the Dotted Line: Simplify the Process with eConsent

Prelude Modules: eConsent 

In clinical research, obtaining informed consent from study participants is a critical component of the enrollment process. Informed consent assures researchers that participants are fully aware of all aspects of their participation, including the purpose of the research, the length of involvement, procedures that will be completed, benefits and risks, etc. 

With the increasing use of technology in clinical trials, electronic data capture (EDC) systems have become a popular method for collecting and managing data, making research more efficient. However, the traditional process of obtaining informed consent on paper is inefficient – printing forms, signing them, then scanning, and finally uploading them into the EDC. Prelude’s eConsent module allows researchers to collect electronic informed consent online without the need for a printer, paper, and pen, streamlining the consent process for participants and researchers. 

Initial Configuration 

• In Prelude EDC, consent forms can be made available at the study level (i.e., all subjects at all sites may use the same forms) or site level (i.e., each site may have its own set of forms for their subjects). 
• Study personnel will upload their documents, such as informed consent forms, authorization of release forms, and any other documents that require a study participant’s signature. Different language versions of the same form can be included in the uploads. 
• Each consent form must be given a name and effective date. The effective date ensures that the correct form is used at any time. So, an updated version of a form with an effective date of May 5th, would then be presented on and after May 5th to new subjects.  
• Now design the eConsent form. Drag and drop our eConsent module and electronic signature fields into the form. Need an investigator’s signature too? Build in those fields as well. 
• Automations can be added to notify and/or send the signed form(s) to the appropriate parties. 

• And, that’s it! The configuration for eConsent in Prelude EDC is simple and straightforward. 

During the Study  

• As subjects enroll, site personnel will give participants access to Prelude EDC and assign the appropriate consent forms. For example, an English speaker would be assigned forms in English, while a Spanish speaker would be assigned those in Spanish. 
• Now the participant receives their Prelude EDC login credentials, logs in, and views all documents that require their signature. 
• After reviewing the forms, participants give consent via their electronic signature and date the form. 

• The participant’s signature and signing date and time are recorded. And, the subject will receive an emailed version of the signed form(s) for their records. 
• Consent is obtained!  

Prelude’s eConsent module simplifies the consent process for clinical trials, saving time and resources. By allowing study personnel to upload consent documents, provide multiple versions, and assign effective dates, eConsent helps ensure accurate and compliant consent collection. For study participants, eConsent offers a convenient way to review and sign consent forms from their own devices, reducing the burden of paper-based consent processes. Additionally, eConsent provides an audit trail, maintaining compliance with regulatory requirements. With these benefits and more, eConsent is a popular choice for researchers running clinical trials.  

Want to incorporate eConsent in your next study?