Wednesday, August 26, 2026 Remote consent aligned with GCP R3 As promised at Spring Meeting and the recent CRA lunch and learn, CCTG's position on remote consent, aligned with GCP R3, is now posted on the Consent Form Policies page. If permitted locally, remote consent (the process of conducting the consent discussion and obtaining informed consent when the research personnel and the prospective participant are not physically in the same room) is acceptable. Person conducting consent discussion must confirm identity of the participant.Documentation of all required signatures must be obtained prior to enrollment.If wet ink signatures are used, the original wet ink participant-signed consent form must be obtained via mail, or at the next scheduled, in-person visit.Fully executed consent form(s) (or equivalent, such as verbal consent documentation) must be retained as part of the Investigator Site File.Fully executed consent form(s) copy (or equivalent, such as verbal consent documentation) must be provided to the participant.Detailed notes of consenting process must be made in the participant’s file.If verbal consent is permitted on a trial, the protocol appendix outlining guidance for decentralized elements will provide necessary parameters. If your site wishes to implement electronic consent (e-consent) for an applicable trial, please contact cer@ctg.queensu.ca. Where CCTG is not the Lead Group, CCTG will additionally confirm acceptability of e-consent with the Lead Group. In addition, the Guidance for Decentralized Elements appendix in the protocol will similarly be updated in future. If you have any questions, please send them to Susannah Groen (sgroen@ctg.queensu.ca) or to cer@ctg.queensu.ca. Thank you!
