Patient Recruitment
Electronic Informed Consent (eConsent)
Electronic informed consent (eConsent) is the use of electronic systems and processes (multimedia, interactive content, electronic signature) to deliver informed consent information to clinical trial participants and to document their consent.
FDA and OHRP issued joint eConsent guidance in 2016 endorsing electronic delivery as long as comprehension, voluntariness, and 21 CFR Part 11 compliant signatures are preserved. eConsent typically improves comprehension scores, reduces consent errors, and supports remote enrollment in decentralized trials.
Common platforms include Medidata Rave eConsent, Clinical Ink, and Signant Health TrialConsent.
Related terms
Informed Consent Form (ICF)
An informed consent form (ICF) is the document a clinical trial participant signs after a documented informed-consent discussion confirming they understand the study's purpose, procedures, risks, benefits, alternatives, and their rights as a research participant.
Decentralized Clinical Trial (DCT)
A decentralized clinical trial (DCT) is a clinical study in which some or all trial activities; recruitment, consent, dosing, monitoring, data capture; occur outside traditional brick-and-mortar sites, typically in the participant's home or community setting and supported by digital tools.
Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
An Institutional Review Board (IRB) in the U.S. or Independent Ethics Committee (IEC) outside the U.S. is an independent body that reviews and approves clinical trial protocols, informed consent, and recruitment materials to protect the rights, safety, and welfare of human research participants.
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