Signant SmartSignals eConsent eConsent Ensure patient comprehension and audit-ready consent documentation Informed consent is a fundamental element of ethical clinical research. A common reason for early participant withdrawal is not understanding the requirements of the study, and electronic informed consent is associated with improved comprehension compared to paper documents. Further, eConsent simplifies version control and re-consenting, and eliminates data ambiguities associated with paper forms – leading to fewer audit findings. Gain informed signatures Improve comprehension Provide more engaging content and question flagging for better comprehension. Eliminate audit findings Unlike paper consent forms, our digital platform eliminates ambiguities as well as provides a fully transparent and traceable time/date stamped process. Ensure correct ICF versions You never have to worry about using older ICF versions – our consent solution takes care of it for you. Error-free re-consenting Streamline the re-consenting process to meet study amendments, at home or at site. OFTEN COMBINED WITH: eCOA > Patient Concierge > Sensors & Wearables > Telemedicine > Download Brochure Why choose Signant SmartSignals? 1 Simple Signant SmartaSignals eConsent simplifies patient consent for studies at any scale with the industry’s leading platform for remote or on-site consent. 2 Flexible The flexible platform facilitates patient-investigator discussions, accelerates mid-study reconsenting, and guarantees the correct versions are used at all times. 3 Robust From design to trial experience and document management, our robust SmartSignals eConsent solution lets participants make informed decisions and reduces burden for all. Signant SmartSignals eConsent benefits everyone Participants Transforming the traditional paper consent form into an engaging digital experience, Signant SmartSignals eConsent supports various learning styles and checks comprehension. Sites & study collaborators Say goodbye to multiple devices and logins – our Signant SmartSignals eConsent can be deployed with our eCOA, RTSM, and Patient Engagement solutions. Sponsors The intuitive interface provides a real-time, interactive picture of study progress, while the complete audit trail minimizes regulatory risks. eConsent solutions to support any study At Signant, we provide solutions to best support your study. When it comes to eConsent, we give you the freedom to choose between a simplified, PDF-based consent form and a fully interactive, multimedia consent experience. Both of our eConsent options allow participants to learn study requirements at their own pace before they consent/reconsent. Best of all, each option can be rapidly implemented and applied to on-site, virtual, or hybrid studies. PDF-based eConsent This PDF-based eConsent process imports and presents existing PDF versions of the informed consent form (ICF) and enables electronic or digitized signature sign off. Available remotely and during a site visit, it contains important additional elements associated with eConsent, such as ICF version control, and re-consent process management. PDF-based eConsent is ideal for simple studies, phase I, and rapid implementation. Interactive eConsent Our most advanced option, our interactive eConsent offers a leading, engaging experience for the participant. Interactive content includes embedded video and audio playback, comprehension tests, and the ability to flag content to ask focussed questions about aspects of the study during discussions with the investigator. Self-service customers will have access to template libraries to speed ICF assembly and study build. Reporting dashboards will provide further insights to aid ICF revision and future development – indicating, for example, questioning hotspots where more detail may be helpful. You choose your involvement level Both eConsent options are available in a self-service model, where you use your existing infrastructure to develop unique consent forms and documentation, and have complete control over the consent process. Need more guidance? Add on project delivery services and our experienced operational delivery team will manage the entire process for you. Ask us about our Design and Consultancy Services which support your team in a self-service model. Frequently Asked Questions What is clinical trial eConsent? Clinical trial eConsent (electronic informed consent) is a digital consent process that potential study participants undergo prior to enrollment as well as throughout the study to confirm their comprehension. eConsent may employ multiple electronic media to convey information related to the study and obtain informed consent. It can be used remotely or on site. What types of studies can be supported by eConsent? Our eConsent solutions can be used for traditional, site-based eConsent forms as well as remote, at-home consent forms. Signant’s tiered options support a wide range of clinical research studies – from Phase I studies to global Phase III studies. Why should clinical researchers transition from paper-based consent forms to eConsent forms? By switching from traditional forms to eConsent forms, sponsors can expect significant improvements, such as enhanced clinical data quality and traceability, minimized audit findings, real-time visibility and monitoring, increased site efficiencies, as well as a centralized document mangement. How can clinical trials improve compliance with eConsent? eConsent improves adherence in clinical trials by ensuring study participants sign the correct consent form version. It uses date and time stamps as well as real-time monitoring for better traceability. Does your eConsent solution offer data integration tools and clinical data exchange with other systems? Signant’s eConsent solution offers integration with our other clinical data solutions from our SmartSignal product suite, as well as with other eClinical systems. Want to learn more? Add eConsent to your study to manage the various consent forms more efficiently – contact our team today. Connect With Us
Informed consent is a fundamental element of ethical clinical research. A common reason for early participant withdrawal is not understanding the requirements of the study, and electronic informed consent is associated with improved comprehension compared to paper documents. Further, eConsent simplifies version control and re-consenting, and eliminates data ambiguities associated with paper forms – leading to fewer audit findings.
Improve comprehension Provide more engaging content and question flagging for better comprehension. Eliminate audit findings Unlike paper consent forms, our digital platform eliminates ambiguities as well as provides a fully transparent and traceable time/date stamped process. Ensure correct ICF versions You never have to worry about using older ICF versions – our consent solution takes care of it for you. Error-free re-consenting Streamline the re-consenting process to meet study amendments, at home or at site.
Signant SmartaSignals eConsent simplifies patient consent for studies at any scale with the industry’s leading platform for remote or on-site consent.
The flexible platform facilitates patient-investigator discussions, accelerates mid-study reconsenting, and guarantees the correct versions are used at all times.
From design to trial experience and document management, our robust SmartSignals eConsent solution lets participants make informed decisions and reduces burden for all.
Participants Transforming the traditional paper consent form into an engaging digital experience, Signant SmartSignals eConsent supports various learning styles and checks comprehension. Sites & study collaborators Say goodbye to multiple devices and logins – our Signant SmartSignals eConsent can be deployed with our eCOA, RTSM, and Patient Engagement solutions. Sponsors The intuitive interface provides a real-time, interactive picture of study progress, while the complete audit trail minimizes regulatory risks.
At Signant, we provide solutions to best support your study. When it comes to eConsent, we give you the freedom to choose between a simplified, PDF-based consent form and a fully interactive, multimedia consent experience. Both of our eConsent options allow participants to learn study requirements at their own pace before they consent/reconsent. Best of all, each option can be rapidly implemented and applied to on-site, virtual, or hybrid studies.
This PDF-based eConsent process imports and presents existing PDF versions of the informed consent form (ICF) and enables electronic or digitized signature sign off. Available remotely and during a site visit, it contains important additional elements associated with eConsent, such as ICF version control, and re-consent process management. PDF-based eConsent is ideal for simple studies, phase I, and rapid implementation.
Our most advanced option, our interactive eConsent offers a leading, engaging experience for the participant. Interactive content includes embedded video and audio playback, comprehension tests, and the ability to flag content to ask focussed questions about aspects of the study during discussions with the investigator. Self-service customers will have access to template libraries to speed ICF assembly and study build. Reporting dashboards will provide further insights to aid ICF revision and future development – indicating, for example, questioning hotspots where more detail may be helpful.
Both eConsent options are available in a self-service model, where you use your existing infrastructure to develop unique consent forms and documentation, and have complete control over the consent process. Need more guidance? Add on project delivery services and our experienced operational delivery team will manage the entire process for you. Ask us about our Design and Consultancy Services which support your team in a self-service model.
Add eConsent to your study to manage the various consent forms more efficiently – contact our team today.