Mike Straw - Apr 9, 2019

How eSource and eConsent Change the Future of Clinical Trials

Throughout the history of clinical trials, record keeping has been a very manual process with paper and physical logs. As anyone can see, it could become quite problematic to use such an outdated method for data keeping, especially when it comes to keeping an audit trail.

That’s where modern-day technology comes into play.

It’s only been the last few decades where it has become common for information to be stored digitally. Because of that, clinical trials have gone towards utilizing both eSource and eConsent to make enrolling, participating in, and tracking the progress of clinical trials more streamlined than ever before.

What is eSource?

Before talking about eSource, you need to know what source documentation is at the base level. According to the Food and Drug Administration (FDA), source documentation is the initial collection of data within a clinical study. This source data, which has often been documented manually, includes things like initial blood pressure readings, weight, blood glucose levels, etc.

eSource is taking all of the data captured manually via classic “pen and paper” and digitizing it upon initial capture.

How Does eSource Help?

By implementing eSource into clinical trials, there are quite a few benefits that those involved will notice almost immediately.

First off, eSource helps eliminate the unnecessary duplication of data while reducing the possibility of transcription errors. In addition, the usage of eSource allows for real-time entry of data rather than waiting until after the visit is over to enter the information. The benefit of that is that it helps eliminate the potential for information being lost in translation between the visit and data entry.

1. Delegate roles and access

computer screen


2. Standardize forms and prepopulate information

form

 

3. Enter source data during visits

folder


4. Automatic audit trail generated
award ribbon

The addition of eSource also facilitates the remote monitoring of and real-time access to the data. If any information is needed or needs to be verified, it’s “easily” accessible by those allowed access; it makes it easier to track any updates or changes by generating an audit trail right from the beginning of the process.

Lastly, eSource helps keep the collected data secure thanks to being stored digitally. Manually collecting the data requires physical binders of information to be stored, leaving them susceptible to flood, fire, or other elemental damages. By sourcing the data electronically, the risk of physical destruction drops substantially. The only major risk at the point is making sure data is properly backed up and that security measures are in place to keep those who don’t need access out of the files.

What is eConsent?

Past research has shown that paper-based Informed Consent Forms (ICFs) do not help create reliable quality dialogue and informed decision-making. This can lead to rushed or even harmful decisions by potential participants due to having to read through near countless amounts of information.

Like sourcing, the antiquated method of having participants read through and sign form after form is not only long and arduous, but it’s a pretty wasteful use of paper. eConsent is the electronic -- hence the “e” -- version of improving the consenting process.

From a virtual dictionary to pictures to even videos, eConsent gives patients as much information as possible to help with the decision-making process.

How Does eConsent Help?

This newer way of getting consent from patients allows sites to utilize more technology to help make sure the most qualified people are participating.

Through the use of different multimedia elements, participants can learn everything they need or want to know about a study. Information is presented to participants in an easier to understand way that is more consistent and simplified throughout.

Participants can view the materials at their own pace without the feeling of being pressured to read through forms. It can also be tailored to the learning style of the participants rather than a one-size fits most sort of process.

For a more detailed list of benefits, TransCelerate released a table that breaks down the benefits to participants in greater detail.

 

Potential Benefit
Stakeholders Affected

Increases comprehension and retention of information compared to a lengthy and complex paper document (e.g., complex procedures or study treatments can be shown visually and/or explained out loud)

Study participants

Allows study participants to choose their preferred method of learning

Study participants

Better informed participants are more likely to make an informed decision whether to participate, can better manage their study expectations, and can become active partners

Study participants

Increased understanding leads to better discussions on ICF content site staff and increased compliance

Study participants

Certain functionalities can be included to help vulnerable populations (e.g., visually impaired, pediatrics)

Study participants

Uses technology that is already regularly used in daily life

Study participants

More engagement with consenting process: empowerment, owner autonomy

Study participants

 

It’s not just the participants of the clinical trial that are helped by the implementation of eConsent. Those helping conduct the study also benefit from its usage.

The potential for audit and inspection findings is reduced due to patients understanding everything before agreeing to take part in the trial. The amount of paperwork -- and the risk of miswritten information -- is reduced to increase the workflow of the sites managing the studies. This can also lead to a lowered burden or less anxiety on staff, which can help them work on more high-level tasks during the study and address more participant-specific concerns that may arise.

Like every new method of performance, however, there are potential barriers that may come up. Utilizing eConsent is introducing a new technology that may come with various hurdles like a significant initial investment for software and training of staff. Other barriers include a longer setup as compared to using paper as well as needing to implement a backup system in the event of system failure.

How Does eSource and eConsent Impact You?

The way eSource and eConsent helps clinical trials and everyone involved can’t be understated. It’s been touched upon in detail in prior sections, but to summarize, it makes the process of enrolling and participating easier than it has been in the past.

When working with a site that utilizes both eSource and eConsent, you can feel a sense of comfort that the information being captured from them is not only safely stored but it’s accurate as well. On top of that, all participants can rest assured that they will be presented with all study information in a fashion that best helps them understand the potential risks of what they are signing up for and what all of the research goes towards.

As with everything, there are still unknowns with the two newer approaches, but there is no question that clinical research is moving to a digital, more secure future for all parties.

Written by Mike Straw

Mike Straw is the lead developer at TrialScout. With the visitor in mind, Mike's primary focus is to make sure TrialScout is not only easy on the eyes but easy to use for everyone. In addition to development, he helps create content and graphics for TrialScout. Mike is also is a veteran journalist who has been lucky enough to travel across the United States and Canada while having his work appear on major outlets such as Yahoo! and Sports Illustrated. When not focusing on his work, Mike spends his free time honing his craft as a guitarist while writing his own music.