ACRP Greater Nashville Chapter Webinar Replay: Regulatory Considerations for 21st Century Paperless

When:  Feb 26, 2019 from 5:30 PM to 7:00 PM (CT)
Associated with  ACRP Greater Nashville Chapter
Webinar Replay: Regulatory Considerations for 21st Century Paperless Trials

Program Agenda:

5:45PM – 6:45PM Webinar
6:45PM - 7:00PM Discussion  

 

Program Description:

The FDA and other regulatory bodies have issued multiple guidance documents addressing requirements when using technology tools to execute paperless clinical trials. The push from the regulatory agencies has occurred despite a risk-averse pharmaceutical industry, still comfortable living in a “paper world.” This risk aversion is in part due to an irrational fear by sites and sponsors of receiving a FDA Form 483 when an FDA inspector discovers, for example, that a patient was born in 1982, when in the study database it is recorded as 1983, even when there is no impact on the study results. Additionally, the clinical sites are also fearful of losing business as a result of any FDA Form 483 finding, however minor.

The following are examples of regulated clinical trial software: 1) Data capture (EDC) systems; 2) Electronic informed consent; 3) Electronic trial master file (eTMF): 4) ePRO and eCOA; 5) Dedicated tablets collecting and storing data in real time; 6) Mobile Apps; and 7) Web-based systems collecting data in real time which transmit the data to the study database only after the source record is securely received and stored in an independent eSource storage location under control of the study site.

Upon completion of this Webinar, attendees should be able to:

  1. Understand the future landscape of paperless clinical trials
  2. Understand regulatory concerns when running paperless clinical trials
  3. How to “separate toys from tools” when choosing mobile and related devices

 Target Audience:

  • CRCs
  • CRAs
  • Project Managers
  • Regulatory Affairs/Compliance
  • Data Managers (Site, Sponsor, CRO)
  • Medical Monitor, Medical Officer, Project Physician
  • Clinical Research Administrators

Further Information:

David Nilson – Chapter President

615-438-1615

Location

Dial-in Instructions:
WebEx invitation will be provided after event registration on Eventbrite

Contact

David Nilson
615-438-1615
nilsonrn@hotmail.com