An Informed Consent Form (ICF) contains an explanation in lay language of the purpose and other aspects of the clinical trial relevant to the potential participant’s decision to participate (referred to as Participant Information Sheet, written information, …) as well as documentation of consent (certification of consent), presented within the same document or as separate documents. The purpose of the ICF is to obtain and document freely given informed consent from the trial participant by means of a signed and dated written ICF.

The ICF should include the required elements as defined in ICH E6, such as a general statement and background; purpose and description of the trial design, treatment, and procedures; risks, benefits, and alternative care options; costs/payment and compensation; confidentiality; and participant’s rights.

The ICF should be written in a language that the potential participant understands. It should be simple in style and content. The use of visual aids may facilitate understanding. The language might need to be adapted to country level to ensure compliance with the local requirements.

The ICF can be updated if new information becomes available that might be relevant to the participant’s consent.

The ICF (update) should receive approval/favorable opinion from the institutional review board (IRB)/independent ethics committee (IEC) in advance of use. In the US, a Long Form or a Short Form combined with an oral explanation can be used. When a Short Form consent document is used, the IRB should review and approve the written summary of the full information to be presented orally to the potential participants.

The Medical Writer can be involved in the document development process (eg, writing, circulating for review, implementing comments), after or during development of the Clinical Trial Protocol.