As a direct and sole result of the outbreak of the coronavirus disease (COVID-19) and due to circumstances beyond our control, DIA announced that it has decided to change the format of the upcoming Digitial Technology in Clinical Trials meeting from “face-to-face” (in-person) to entirely virtual.
For more information, please review the list of Frequently Asked Questions.
Short Course requires Pre-Registration and is an additional fee.
Evidence suggests that capturing clinical outcome assessment data electronically (eCOA) has many benefits over paper. However, barriers to adoption still remain. Poor adoption is in part attributable to unfamiliarity with benefits, but also poor experiences during study start-up, absence of clear expectations among sponsors and vendors, and misalignment among all stakeholders. This is also an area where no formal training exists for sponsors or eCOA providers.This short course is designed to introduce participants to key eCOA topics which will be reviewed through the course objectives.
The interactive short course, created in collaboration with the Critical Path Institute’s ePRO Consortium, will provide real world examples and case studies including challenges and proposed solutions for the audience to work through in small groups.
At the conclusion of this short course, participants should be able to:
- Discuss the benefits of and barriers to eCOA adoption
- Describe regulatory guidance applicable to eCOA vendors
- Identify key measurement science and design principles applicable when using eCOA
- Discuss considerations when choosing a solution for your study based on study design and patient population
- Identify start-up processes and considerations for migrating from paper to electronic modes of data collection, developing specification documents, and conducting user acceptance testing
- Describe the role of sponsors and sites in the trial technology implementation process and in optimizing quality of data collected with eCOA
- Analyze best practice recommendations for training site staff and study subjects on eCOA data collection in clinical trials
- Discuss considerations for the use of bring your own device (BYOD) in clinical trial