WELCOME TO THE DELVE BLOG.

Implementing eConsent in Clinical Trials

Patient Electronic Consent

At Delve Health, we took extensive measures to develop a scalable eConsent solution that can be integrated with various solutions to streamline the data flow.

Below are the core elements we implemented to ensure scalability and flexibility

  • Flexible workflows: Flexibility to accommodate multiple prescreening, screening, and re-consent, all with a simple interface to help users easily manage the eConsent.
  • Version Control: In order to allow for Protocol amendments, Clinical StudyPal allows for multiple versions.
  • Global Access: Allowed for different consents to be developed for different countries. An eConsent can be developed at a site level, country level, global level.
  • Multimedia libraries: Informed consent forms have become longer and more complex. Patients and caregivers may be dealing with illnesses and high-anxiety situations, which make reading ICFs difficult. Without our eConsent design form, the user can easily upload multimedia (video/images) to simplify the consumption and comprehension of the data.
  • Socially distant signatures: Allowing individuals to conduct a video signature or utilize their phone to sign and upload their ID.
  • Remote monitoring: Allowing the study team to easily review all the consent information.
  • Site Review: Investigators can simply review the patient consent remotely, and sign/approve the consent information electronically.

Clinical StudyPal eConsent module has been used globally with over 2100 patients consented on the platform. Delve Health provides an end-to-end solution for all your decentralized needs.

Clinical StudyPal utilizes mobile, web and SMS notifications to help improve study compliance and patient engagement.

Robust Technological Infrastructure

Delve Health’s eConsent solution leverages the Google Cloud infrastructure. Google Store creates a secure, redundant, and scalable platform for the application to run on. Google HIPAA compliant infrastructure also ensures that personally identifiable information data is not moved across borders from where it is collected, a critical component of privacy regulation compliance.

The system also supports single sign-on capabilities, allowing site users to effortlessly move between Complete Consent, electronic data capture, IRT, and any other technologies using the same service. Single sign-on solutions are 21 Code of Federal Regulations Part 11 compliant and increase efficiency and reduce frustration without increasing risk.

Click here for a 30 min demo.

SIMILAR ARTICLES

remote clinical trials | Delve Health

7 Ways to Increase Clinical Trial Patient Engagement with SMS & Messaging Apps

Most of us agree that a clinical trial’s success depends heavily on patient engagement. The importance of design patient-centric studies cannot be understated. Engaged
eConsent allows for video conferencing.

The Rise of eConsent Forms and its Impact on Patient Recruitment

Informed consent is one of the founding principles of research ethics. Its intent is that human participants can partake in medical research freely (i.e., voluntarily)
Delve Health delivers wearables directly to patients all over the world.

Delivering Devices and Safely Collecting Real-World Data (RWD)

Can we say something more around why we are focusing on collecting raw data from Wearables? Wearables are being implemented in more and more
banner | Delve Health

Are Wearables a Fade OR Are They Our Future?

Wearables in clinical research is a “hot topic” and all the “buzz.” While many people feel it will propel the clinical research enterprise into

What is eConsent

Defining eConsent in Clinical Trials The US Food and Drug Administration (FDA) has defined electronic informed consent (eConsent) in clinical trials as “the use of
Research In The United States | Delve Health

Opportunities In Transforming Clinical Research In The US

Clinical trials are essential for the development of new drugs and treatments. The goal of clinical trials is to find better ways to prevent,
Previous
Next