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The Ugly Truth About Paper Diaries

Bridget Tyrka: May 14, 2019 4:12:21 PM

Although paper diaries may be familiar to many sponsors and clinical trial sites, traditional patient journals have the ability to invalidate otherwise reliable and valid clinical trial assessments. That unfortunate scenario can contribute to the ruin of multi-million-dollar clinical trials, depending on primary and secondary objectives as outlined in clinical protocols, which are the main objectives for clinical assessments of safety, efficacy and efficaciousness (Gupta, 2015).

eConsent: Definitions & Details

Sharon Rosenberg: Apr 15, 2019 12:25:38 PM

 eConsent is a technology-driven, patient-engagement tool that aims to improve site/patient discussions and clinical trial efficiency. It should provide a detailed overview of the clinical trial process in the patient’s own language, while including guided instructions for completing the eConsent and allowing the patient to electronically sign and optionally download the signed consent document. This helps to promote better comprehension of content by incorporating multi-media components like audio and video, or documents with voice-overs in the patient’s own language. The process allows patients to explore trial-specific words and concepts at their own pace through linked text, which can improve the quality of discussions between site staff and patients in a less intimidating way.”