eConsent is rapidly becoming the new consent standard for trials
Electronic Informed Consent, also called eConsent, is rapidly becoming the new consent standard for clinical trials. This trend has been accelerated by the global COVID-19 pandemic as eConsent can help ensure the continuation of the informed consent process when face-to-face contact is impossible or avoided. Trial participants who feel insecure or inconvenient about visiting the site can consent from home.
Reap the benefits of eConsent
eConsent can improve one of the most important steps in the consenting process – the process of informing the participant adequately. eConsent can provide options such as interactive learning using multimedia components, a tiered approach to tailor to learning preferences, testing of the participant’s comprehension, and review of the participant’s questions. Furthermore, it can allow for continuous improvement of the consent content through surveys and rapid notifications to the participants of any amendments. Trial participants can review the eConsent at his/her own pace at home before the discussion with the site staff. This can overall improve the discussion, engage the participant, and increase protocol adherence and enrollment rates.
The integrity of the consent process can be ensured with eConsent through fewer consent-related findings, global signature compliance, reliable date/time stamps, and easy access to audit trails.
Increased tracking capabilities can enable the ability to get real-time consent status across sites and immediately identify any consenting issues.
eConsent can improve the reconsenting process by allowing reconsenting to be performed remotely and for quicker delivery of new information to the trial participant.
It is important to consider whether eConsent would be the right fit for your trials as early as possible as it can take several months to set up eConsent from vendor selection to first participant enrollment. All strengths and limitations need to be identified. It can be a good idea to run a pilot trial before implementing eConsent across the entire organization.
The organizational impact is important to address as well as site engagement. The impact on sites and areas of resistance can be identified as well as methods to be implemented to overcome these. The requirements for IRB/IEC submissions should be fully understood and may be different for each country. Ways to improve the efficiency of the submission approval process should be identified.
Selecting and implementing eConsent
It is important to carefully analyze and plan your eConsent implementation. We at HERAX can help in all phases of the project including the early analysis, business case development, vendor selection, trial planning, and impact analysis. We provide experience with and knowledge of the vendors in the market and ensure that the solutions are carefully assessed through a structured vendor selection process.
We are experts in creating change management strategies which is crucial for a successful adaption of eConsent within the organization and trial teams.
After a thorough planning phase, we can help execute the plan, by establishing the new business processes and technology and training of trial managers and monitors. We are experts in validation and can also perform go-live activities including establishing operational procedures.
Are you considering eConsent for your clinical trials?
We can help you get started with your eConsent analysis, vendor analysis, business case, or pilot to evaluate whether eConsent would be the optimal solution for your trials. A thorough analysis of the business needs is essential to avoid unnecessary costs and changes.
We can assist you by combining a proven Life Science specific project methodology with a best-in-class knowledge of the trial execution area.
Sarah has supported clients from the pharmaceutical and medical device industry, both in Denmark and the rest of Europe. As a senior consultant, she specializes in IT Quality, IT project management, and business processes for computerized systems in Life Science. She has a deep knowledge of the business process supported by CTMS, EDMS, eTMF, and RIMS and a solid understanding of the regulatory requirements. She is also one of our specialists in eConsent solutions. Sarah has a strong background in pharmaceutical research, which she has been applying to her projects over the past years. Sarah holds a Master of Science in Engineering in Biotechnology and has worked in both research and biopharmaceutical production before joining HERAX.