Participant consent is one of the most important preliminary steps of a research study. One of the most useful and valuable tools researchers can use to get consent from the participants and the staff involved in eConsent.
With a thorough and robust eConsent process in place, you can improve the consenting quality and reduce the on-site audit findings. It can also help you move from an in-person study to the more convenient virtual or hybrid methods and still get the same results.
Before you develop and implement an eConsent process, there are some factors you should consider ensuring that the entire process is streamlined and convenient for all parties involved. Keep reading to find out how you can do it.
Evaluate Organizational Requirements
When choosing an eConsent tool, you should first evaluate how it can affect your organization as well as review committees. In particular, you should consult with your company’s Independent Review Board (IRB). The processes vary in different IRBs. In some IRBs, you may not require prior approval to implement a new eConsent system but simply an attestation that the new system is in line with the already-approved consent.
For some IRBs, you may have to provide further details and screenshots. Therefore, your first step should be to speak to your IRB and direct your queries toward them.
Understand Study Parameters and Participant Population
When choosing an eConsent process, you should ensure that it’s in line with the type of study you’re conducting and the population of participants involved. For example, if you’re doing a low-risk study, you may have to follow a different process than high-risk research. In addition to this, you should also consider other factors such as participants’ learning styles, access to the internet, language barriers, and access to the clinic.
Your eConsent process should support your study’s parameters and ensure a seamless experience for the participants.
Set up and Test the eConsent Platform
Before using the eConsent system, it’s important to implement it properly. You should get experts to configure the system. Once it’s set up, you should test the system out and involve the staff that will be using the system during the study. This will give you the chance to use the system before the study and get acquainted with all its features.
The better they understand it, the easier it’ll be for them to explain it to the participants. The staff can also build the required fields and rules around how participants will sign the documents.
Quality Clinical Trial Data Management Solutions
Platforms such eConsent, EDCs, and eCRFs will give the best results only if they’re sourced from reliable manufacturers and distributors. If you’re looking for a robust eConsent system, ClinicalPURSUIT is your best option.
The Missouri-based clinical trial technology company has comprehensive valuable systems and tools for clinical trials, including EDC software, SDVs, interactive response technology, clinical trial remote monitoring, and more.
Get in touch with our team to learn more.
