Benefits of an eConsent Solution in Clinical Trials

The Cloudbyz CTMS eConsent solution offers participants the chance to review materials as often as they wish, giving them time to reflect on their choices over time. In advance of conversations with staff, prospective and active participants can bookmark any aspects of the study they may wish to discuss further.

The Cloudbyz CTMS eConsent solution is integrated with Cloudbyz CTMS and centralized on industry leading Salesforce 1 cloud platform, which offers multiple advantages to participants, sponsor organizations, clinical sites, and ethical review boards.

The Cloudbyz CTMS eConsent is built based on templates, which can be created and managed in the system more efficiently. Upon creation of the informed consent template, system automatically collects study and protocol information and presents it in structure format for research team to review and modify details and add additional multi-media content such as videos and graphics explaining the procedures. Once template is created with required consent text and media, template can be submitted for approval from IRB and Sponsor using built-in configurable approval workflow. Upon approval, informed consent template can be used for informed consent process to onboard participants.

Cloudbyz CTMS is cloud based and integrated platform and data from all sites is collected in a centralized and secure platform, stakeholders can have real-time access to data from the consent and enrollment process across a single or multiple studies. Data can be sorted and shared based on individual access rights to show participant-identified data for the site staff and site monitor, and de-identified data for sponsors, institutional review boards (IRBs).

Using Cloudbyz CTMS platform, sponsors that have previously had to rely on manual process and silo systems for reporting screening and enrollment from paper-based systems can now track screening and enrollment rates remotely in real-time across large, multi-site studies. Metrics derived from the data collected can provide quick dashboard views of what is happening on a study, such as the number of participants consented, countersigned, or withdrawn from the consenting process.

Real-time reporting of this data reveals key information, including words or concepts commonly marked as unfamiliar by participants and knowledge assessment questions indicating topics participants have difficulty comprehending. The system enables remote monitoring of how much time the participants spend with the consent material. Removing participant identifier data from reports and metrics, can provide sponsors with mean and individual review times of the consent materials, as well as results of comprehension assessments.

Cloudbyz CTMS eConsent solution provides capabilities for central review of the eConsent metrics that can allow for more remote monitoring activities, reducing the number of trips by site monitors and reducing the cost to the sponsor for these activities. In addition, many of the metrics can be used to develop or improve risk-based monitoring activities to reduce risk of non-compliance with regulatory statutes.

Cloudbyz CTMS eConsent provides an accessible, consistent IRB and Sponsor approved message, empowering patients to make informed decisions regarding their participation in a clinical study. Without disrupting the standard IC process, use of eConsent can significantly impact a study and following are some of the benefits:

Benefits of Electronic Consenting for Participants

• Convenience – Do not have to go to a research site
• Less pressure and anxiety – Can review the consent form and consult with family members without feeling pressure to sign right away
• More informed – Participants can review the consent form at their leisure, allowing them to make a more informed decision. In addition, supplementing consent forms with electronic technologies could help participants better understand the research.
• More engaged – digital technologies can engage patients more than traditional paper consent documents.

Benefits of Electronic Consenting for Researchers

• Decreasing Screen Failure Rates
• Dramatically increasing retention
• Higher Enrollment – Increased convenience for subjects could lead to higher enrollment, though there is not much data on this subject
• True Informed Consent – Electronic consent could help participants to be more informed, in turn allowing researchers to be more compliant and more ethical.
• Allowing personnel to focus efforts on additional recruitment and study execution
• Minimizing time invested on unwilling and unable subjects
• Helping to reduce risk of litigation with standardized, approved communication and process documentation
• More Compliant Participants – participants could also be more engaged. With higher engagement often comes greater compliance.
• Convenience – No in-person appointment scheduling
• No travel reimbursement – No commuting or parking costs
• Paperless – Ability to manage documents electronically
• Industry Leader – Researchers have the opportunity to establish themselves as innovators in improving consent processes
• Increased capability – Can conduct studies with a larger participant base and more varied types of research due to ability to consent participants remotely

Cloudbyz CTMS eConsent solution also offers consistency across global studies. Each eConsent can easily be translated in multiple languages, allowing a consistent message to be provided to patients of all demographics.

Cloudbyz CTMS eConsent solution is available on AppExchange

Please email us at info@cloudbyz.com for more details on Cloudbyz CTMS eConsent solution.

FDA Information Sheet, “A Guide to Informed Consent”, available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm