Is 5thPort compliant with FDA 21 CFR Part 11? What about other clinical compliance requirements?
Yes. 5thPort is compliant with FDA 21 CFR Part [...]
Tell me about integration. Can 5thPort integrate with systems we already use?
5thPort brings eConsent into clinical research software solutions that your [...]
What does 5thPort’s audit trail capture?
5thPort maintains a detailed audit trail of eConsent activity, capturing [...]
We have multiple study sites. How can we keep track of consent activity across all of them?
5thPort gives sponsors and study teams visibility into consent activity [...]
Can a Legally Authorized Representative (LAR) complete eConsent for a participant?
Yes. When permitted by the study protocol and applicable regulations, [...]
What happens when a consent form changes and participants need to re-consent?
Clinical trials evolve. New information may become available, protocols may [...]
How can we make sure participants understand what they’re consenting to?
Under the FDA’s informed consent requirements and guidance, informed consent [...]
What if a participant needs the consent information in another language?
5thPort supports multilingual eConsent across both left-to-right (LTR) and right-to-left [...]
What if a participant has a question about something in the consent form?
Participants don’t have to move forward with something they don’t [...]
Does 5thPort store completed eConsent forms?
5thPort captures the activity associated with the consent process in [...]