Component Type: Tutorial
CE: ACPE 6.50 Application UAN: 0286-0000-25-509-L04-P; CME 6.50; RN 6.50
Pre-registration required and is an additional fee.
*Please note: Short Courses are stand-alone events. Registration for the main conference, forum, etc. are not mandatory. Already registered? Log in to DIA's
My Account My Events. Patient experience data, through patient-reported outcomes (PROs) and other clinical outcome assessments (COAs) are an increasingly important component of regulatory drug submissions and health technology assessments (HTAs). Instructors will take participants on an in-depth evaluation of the key topics important in successful ePRO implementation, including:
- Selecting, adapting and developing patient-reported outcome measures to meet protocol objectives
- The case for ePRO – when to select an electronic approach, and when paper might suffice
- ePRO implementation best practices to ensure good measurement science
- Migration validity considerations and evidentiary requirements
- Language, translation and licensing considerations
- Implementation steps including vendor selection and user acceptance testing (UAT) best practices
- Modality choices – web vs app, and bring-your-own-device (BYOD) considerations
- Hot topics such as data change processes, mixing modes, special populations, etc.
- Q&A – discussion of participants' own hot topics.
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$50 off your Global Annual Meeting total purchase by registering for two or more Short Courses. Purchases must be made at the same time to receive the discount. Discounts will be reflected on the last page of the cart.
Who should attend? Professionals who have experience in clinical trials and patient engagement and wish to develop their skills on how PRO measurement is best implemented in clinical drug development programs.
Learning Objectives - Demonstrate when to select electronic capture, when to use web vs app, and when to enable patients to use their own devices (BYOD)
- Apply industry best practices to ePRO implementation, translations and other processes such as PRO data changes
- Describe the implementation steps, possible bottlenecks and mitigations, and user acceptance testing best practices
