What is informed consent
Take the patient through an educational process to inform them about the treatment they are about to have. It walks them through the when, what and all the possible outcomes relating to the treatment and capture their ‘consent’.
Informed Consent changes the paper-based documents to a patient/participant education process. The patient education process provides the same information as the traditional paper based documents, but they are provided in a format that is designed to inform and educate the patient, using a language they understand and multi-media components to explain what a clinical trial is, what their involvement in the trial will be and it then tests the patient’s knowledge and provides a method for patient’s to raise queried and questions.
The Informed Consent systems must meet all of current EU and USA regulatory and privacy requirements including GCP, GPDR and HIPAA. Including collection of electronic signatures (eSignature), tracking of patient statuses and audit trails of all changes to consent forms and records.
The problem it solves
Increases retention of patients in clinical trials and reduces time to market for product, by improving the effectiveness of recruitment and education, which directly impacts on increased clinical trial retention.
US informed consent projects have had improved their recruitment from 45% of contacted patients to over 70%, and increased patient retention during the trial from 62% to over 90%.
How Evado solved the problem
Evado Informed Consent is a fully compliant paperless app that ensures that patients are fully informed. Evado eConsent has built in compliance monitoring that can be run on either a desktop or a tablet computer. Audio visual and cartoon graphics can be included to enhance patient comprehension. Evado’s compliant signature collection has inbuilt auditing and meets current EU and USA regulatory requirements. Evado’s Informed Consent can be run as a standalone app or integrated into Evado Clinical.
The eConsent module includes:
- Evado supports versioned consent forms to manage any changing consenting requirements throughout the execution of the study.
- Design tools assist in the creation of the informed consent form. A form can be broken into one or more sections or groups with each section or group containing one or more page fields.
- The eConsent form supports rich text, videos, images quizzes or raise queries about the section content.
- If preferred, the patient consent form can be completed at a clinic assisted by local staff and signed off by the patient.
- Sites can monitor the progress of each participant’s consenting process.
- Full audit-trails are kept of all the patient consent data.
- All patient personal information is stored in an encrypted format and time date stamped.
- Full privacy management ensures that only site users can view participant data.
The FDA Informed Consent guidelines state that the purpose of the research must be explained to patients including the patient’s role in the study and how the study would run.
Evado Informed Consent isn’t just a signature confirming that a patient will participate in a study. Informed consent opens up opportunities for patient recruitment and retention that keeps patients interested and engaged in the study. This also benefits patients with low health literacy as the paper based systems can be confusing. eConsent ensures that patients are fully informed. There are long-term financial advantages for sponsors and patients benefit by being fully invested in the studies they participate in. Best of all, patients will comprehend and agree to participate in a study in an informed and meaningful way.
Informed Consent is suitable for remote studies as well as studies that are conducted in the clinic or hospital. Some patients prefer to upload their study data in their own. Industry figures demonstrate that patients are much more likely to complete the trial if they use an Informed Consent application.
What makes it an exceptional solution
- Simplifies the process and make it quick to roll out
- It’s device agnostic
- Can be used remotely or in clinic
- Lower cost for the client
- Unique options with versatility to use with multiple systems including if paper is being used
- Allows for remote clinical trial research (allowing regional participants hence expanding your potential patient pool)
- Support the Australian informed consent requirements.