ECONSENT SOFTWARE AND PATIENT EDUCATION PLATFORM FOR CLINICAL TRIALS

Yes. 5thPort supports eConsent across decentralized, hybrid, and traditional in-person clinical trials. Participants can review consent information and complete the consent process remotely (without study staff present) or at the study site, giving sponsors and CROs the flexibility to use the same eConsent platform across different study models and sites.

This also means that the consent experience doesn’t have to change simply because a participant is remote or if a study uses a mix of virtual and in-person interactions.

No. 5thPort is web-based, so participants don’t need to download an app or install additional software to complete eConsent. They can securely access their consent information through a web browser on their own device, whether they’re participating remotely or completing the process at a study site.

Yes. Once the consent process is complete, participants can download a copy of their signed consent form for their own records.

5thPort captures the activity associated with the consent process in the audit trail, including the appropriate signatures and timestamps, without serving as the long-term repository for completed consent forms.

Participants don’t have to move forward with something they don’t understand. With 5thPort, they can flag specific sections of the consent form where they have questions or need more clarification. The study team can then see exactly what the participant wants to discuss and address those questions directly.

This helps make eConsent a more informed process, and gives participants a voice while making them feel heard.

5thPort supports multilingual eConsent across both left-to-right (LTR) and right-to-left (RTL) languages, helping study teams deliver consent information to diverse participant populations in the language and format they need.

Participants can review important study information in a language they understand, making it easier to ask questions, understand what’s being asked of them, and make an informed decision about participating in the trial.

It’s part of 5thPort’s mission to create a world of empowered patients – where language shouldn’t be a barrier to understanding or participating in their own care.

Under the FDA’s informed consent requirements and guidance, informed consent is more than obtaining a participant’s signature. Participants should be given information in language they can understand, have an opportunity to ask questions, and be supported in understanding the information before deciding whether to participate.

5thPort helps study teams support this process with teach-back questions and comprehension checks built into eConsent. Participant responses can highlight areas where more explanation may be needed, giving the study team an opportunity to address questions or clarify information before consent is completed.

Clinical trials evolve. New information may become available, protocols may change, or an updated consent form may need to be reviewed and signed by participants. Whatever the reason, 5thPort supports re-consent and version control throughout the study.

Study teams can manage approved consent versions, issue the appropriate version to participants, and track which version each participant received and completed. This makes it easier to manage changes across participants and study sites while maintaining a clear, traceable record of what changed, which version was used, and when.

Yes. When permitted by the study protocol and applicable regulations, 5thPort can support eConsent involving a Legally Authorized Representative (LAR) for participants who are unable to provide consent themselves.

5thPort gives sponsors and study teams visibility into consent activity across participating sites, so they can see what has been completed and where follow-up may be needed.

This creates a more consistent consent process across the study and gives teams a clearer picture of participant progress without having to piece together information from individual sites.

5thPort maintains a detailed audit trail of eConsent activity, capturing participant and study team actions, electronic signatures, timestamps, consent versions, and other activity associated with the consent process. It’s called our One Touch Compliance Report, and essentially – study teams can bring this information together into a clear, traceable record of the consent journey. It shows who did what, when it happened, and which consent version was involved.

This gives sponsors, CROs, and study teams the documentation they need to support oversight, audits, and regulatory requirements without having to piece together the consent history manually.

5thPort brings eConsent into clinical research software solutions that your organization already uses – including EHRs, healthcare information systems, and clinical trial management systems (CTMS) – so that education and consent activities can be delivered digitally, at scale.

Read about our integration capabilities here.

Yes. 5thPort is compliant with FDA 21 CFR Part 11, aligns with Good Clinical Practice (ICH-GCP) and EudraLex Annex 11, supports HIPAA requirements, and is SOC 2 Type II certified. You can read about our compliance and security protocols here.