Answers to 5 Key eConsent Questions in 2024

As the life science sector becomes increasingly digital, eConsent has become an effective tool for replacing conventional paper-based methods of consenting subjects/participants. It removes the location-specific barrier for patients, and clinical site personnel while engaging all parties involved providing a straightforward experience and a user-friendly system.

To acquire a better knowledge of eConsent in clinical trials, we compiled a list of the top ten most often asked questions. These questions cover the issues of uptake, integration, and compliance measures, providing useful information for those contemplating using eConsent in clinical trials.

1. Is eConsent only for virtual consenting??

No! eConsent systems should be able to enable a number of workflows to accommodate a wide range of patient demographics and site requirements. A versatile eConsent platform enables you to consent in person, digitally, or on paper, all in one place.

Octalsoft eConsent offers hybrid processes that include graphics, videos, and screen readers, ensuring that participants are comfortable and in control of the process. The technology enables the research team to make video conversations, sign forms, and deliver questionnaires to patients without requiring extra integration.

2. What impact has eConsent had on recruitment and patient retention rates?

eConsent has transformed the patient recruiting and retention process by speeding and simplifying the consent procedure. Not only has it digitized and made clinical trial consent data more accessible and interactive, eConsent also helps in improving understanding and engagement, thus significantly raising recruitment rates. Patients can now peruse through consent forms at their own convenience, revisit sections, and even access multimedia information to better understand the trial’s motives before opting in. This builds confidence and communication clarity, thus increasing the likelihood that patients will commit to a trial.

3. How does Octalsoft’s eConsent system support version management, and what mechanisms are in place to notify participants of updates?

Mid-study protocol changes may need modifications to the informed consent form (ICF). Participants may also be asked to re-consent based on the revised ICF. Octalsoft eConsent can assist in handling this process more efficiently and allows re-consent both on-site and remotely, depending on the research requirements.

If modifications are required, the ICF can be replicated and updated accordingly. Following clearance from the Institutional Review Board (IRB) or ethical committee, the modified version can be published and made accessible to sites for usage.?

4. How do Octalsoft eConsent and Octalsoft EDC interact?

Octalsoft's eConsent and Electronic Data Capture (EDC) technologies may work together to expedite the clinical trial process, increasing efficiency and compliance. eConsent is the first stage in which participants offer their informed permission digitally, and Octalsoft EDC is used to gather, store, and manage trial data. The interoperability of the technologies simplifies and secures how data is handled during clinical trials.?

Once consent is gained by Octalsoft eConsent, the participant's data, including demographic information and consent status, is instantly transmitted to Octalsoft EDC. By having a continuous flow of data between the permission process and the data gathering phase, researchers may analyze real-time information, patient-reported outcomes evaluations, and other documentation from central cloud storage that is immediately accessible to clinical teams.??

5. What integrations are available with Octalsoft?

Octalsoft is a completely interoperable platform capable of integrating with a wide range of data sources, including devices/wearables, EHRs, and other technology platforms.

The Octalsoft platform is an API-first offering, which means that we build the API endpoints before the front-end features, resulting in excellent integration possibilities. We also created webhooks for eConsent, which allow for quick, real-time interfaces with external solutions.??

In Summation

By adopting a digital-first attitude from the start, research teams can ensure that eConsent is not an afterthought but a fundamental component of the study design. This proactive strategy may spark talks, ensuring that sponsors are aligned and on board from the start.?

Do you want to know how you can overcome existing clinical trial challenges, accelerate the development of innovative therapies, and usher in a new era of evidence-based medicine that benefits patients worldwide? Book a Demo with us Now!?