The ePRO Choice: Understanding the Impact of Recent FDA Guidance on Your ePRO Tool Selection

Original Air Date: August 10, 2011
Expiration Date: August 8, 2012
Contact Hours: Earn 1.5 Contact Hours
Level: Intermediate
Cost: $119 Regular Rate; $79 Member Rate

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Who Will Benefit
This activity is intended for Clinical Research Associates (CRAs), Senior CRAs, Data Managers, Principal Investigators, Project Directors, Project Managers, and Statisticians working for Biotech Companies, Contract Research Organizations (CROs), Device Companies, Pharma Companies, and Site Management Organizations (SMOs).

Program Description
The Guidance notes for industry prepared by the Food and Drug Administration (FDA) has been created to make the process of developing and reviewing Patient Reported Outcome (PRO) measures and the submission of electronic source documentation more efficient and transparent for both the FDA and clinical trial sponsors.

The purpose of the Final Guidance for Industry Patient-Reported Outcome Measures (2009) is to provide sponsors and contract research organizations (CROs) with information on how the FDA will assess and evaluate the appropriateness and adequacy of PRO measures used as effective end points in clinical trials. Whereas the Draft guidance for the use of Electronic Source Documentation in clinical trials (2010) aims to recommend practices that will help ensure that electronic source data (including data captured on ePRO tools) are accurate, legible, original, attributable and contemporaneously entered; and meet the regulatory requirements for recordkeeping and record retention. In light of this new Guidance it is vital that sponsors utilize data collation methods that are deemed by the FDA to provide accurate information that will help to make the approval of new therapies more efficient.

This webinar will provide an overview of the current and emerging ePRO landscape and provide a commentary on how these tools comply with the aforementioned FDA guidance notes. By the end of the webinar, participants will be provided with an insight into the processes behind the selection of the correct ePRO tool or tools for their studies and how this process can ensure the development of an accurate picture of the effects of a therapy on patients while adhering to the Guidance set out by the FDA.

Learning Objectives
Upon completion of this webinar, attendees should be able to:

• Describe the ePRO technical landscape and list 2 examples of how this technology can be applied to their clinical trials.
• Describe the impact of FDA regulations on the use of ePRO tools and list 2 examples of how patient data collection methods will conform to future guidance measures.
• Describe 3 factors to consider when assessing tools to collect PRO data.

Presenter
Tim Davis, BSc., is co-founder of Exco InTouch Ltd, an interactive mobile technology company delivering innovative solutions for patient recruitment, compliance and real-time data collection.

Tim has dual honours in Biotechnology and Microbiology from University of Sheffield, 1996. He has held various positions including Data Manager at Parexel International and managing the European technical support group at Procter & Gamble pharmaceuticals. This role involved the first pilot EDC trial through to progressive scale up of EDC throughout the organization.

Tim has published several articles and regularly speaks and chairs at conferences specializing in EDC, e-PRO, new technology implementation and electronic source data.

Disclosure Statement
Mr. Davis states that he has no actual or potential financial conflict of interest in relation to this educational activity. 

Accreditation Information

Continuing Nursing Education
The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. ACRP’s webinar program provides 1.5 contact hours of continuing nursing education credit (Program Number 11147-2011-REP-315).

Association of Clinical Research Professionals
The Association of Clinical Research Professionals (ACRP) provides 1.5 continuing education credits for the completion of this educational activity with the completion of the online evaluation form.  These credits can be used to meet the certification maintenance requirement (Program Number ACRP-2011-REP-315).

Continuing education credits/contact hours are awarded with the completion of an online evaluation form, which must be completed prior to the product’s expiration date. Upon submission of the evaluation form, a link to the printable certificate will be made available on the attendee’s My Tests, Evaluations & Certificates page.