MOST was conducted between 2019 and 2023.  We reviewed reportable consent-related PDs in relation to how informed consent was obtained (paper in-person, eConsent in-person, eConsent remote). PDs were categorized by themes. We utilized goodness-of-fit chi-square tests followed by pairwise testing to detect differences between modalities.

The rate of reportable consent-related PDs per 100 enrollments was: paper in-person: 25, eConsent in-person: 6, and eConsent remote: 13 (p=0.0004). Informed consent obtained using eConsent in-person had fewer deviations than paper in-person (p=0.0015), but not eConsent remote (p=0.19), with no difference between eConsent-remote and paper in-person (p=0.06). PDs were classified into the following themes: missing/incorrect HIPAA documentation, incorrect version of the consent form, incorrect signature, and miscellaneous. Missing/incorrect HIPAA forms occurred in 11%(14% paper in-person, 10% eConsent-remote, 2% eConsent in-person), incorrect version of the consent form 4% (6% paper in-person, 1% eConsent-remote, 0% eConsent in-person), incorrect signature 3% (4% paper in-person, 0% eConsent-remote, 1% eConsent in-person), and miscellaneous 2% (1% paper in-person, 1% eConsent-remote, 3% eConsent in-person).