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There’s increasing interest in using electronic media to supplement or replace paper-based informed consent processes. An electronic informed consent form (eICF) may be used to provide information usually contained within the written ICF, evaluate the subject’s understanding of the information provided, and document that the subject (or the subject’s legally acceptable representative) provides voluntary consent to participate in a clinical study. Electronic informed consent (eIC) processes may use interactive electronic-based technology (including diagrams, images, graphics, videos, narration, quizzes) to facilitate the subject’s ability to comprehend the information and to assess the subject’s understanding of the information being presented during the eIC process.
FAQ: Electronic Informed Consent Form (eICF)
What is an Electronic Informed Consent form (eICF)?
An eICF is a digital version of the ICF that electronically provides study information and documents a participant's voluntary consent to participate in a clinical trial. It can replace or supplement a traditional paper-based ICF.
What information is included in an eICF?
An eICF includes the same information as a traditional ICF, such as the study purpose, procedures, risks, benefits, participant rights, and confidentiality measures.
How does an eICF differ from a traditional ICF?
Unlike a paper-based ICF, an eICF can use interactive features such as videos, graphics, narration, and quizzes to improve and assess participant understanding.
How can Emtex Life Science support the preparation of the eICF?
Emtex Life Science can support the eICF process by drafting content, coordinating reviews, and ensuring that the document is clear, easy to understand, and compliant with regulatory requirements.
Why is professional medical writing support valuable for the eICF?
Professional medical writers help ensure that complex study information is communicated clearly and in a non-technical language, supporting participant understanding and informed decision-making.