RTP Chapter: Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices

When:  Nov 11, 2019 from 5:30 PM to 7:00 PM (ET)

RTP Chapter: Privacy and Confidentiality in the Age of Mobile Apps and Connected Devices

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Speaker Name:
  • Robert Romanchuk, BSHS, CIP, CCRC - Chairperson, Advarra 
Target Audience
  • CRCs
  • CRAs
  • Auditors
  • Project Managers
  • Regulatory Affairs/Compliance
  • Medical Monitor, Medical Officer, Project Physician
  • Quality Assurance
  • Clinical Research Administrators
Program Description
Mr. Romanchuk will walk us through the regulatory environment related to privacy and confidentiality in the age of Mobile Apps and Connected Devices.

Program Agenda

  • Define Mobile Medical Apps and distinguish from General Wellness Devices
  • Describe current scope of FDA oversight of MMAs
  • Discuss data privacy and security issues related to the use of MMAs in clinical research
  • Identify controverted terms contained in Privacy Policies and Terms of Use agreements
  • Discuss subject protections applied to the use of MMAs and connected devices
  • Provide best practices in the design and use of MMAs for clinical research 
Learning Objectives:
Upon completion of this presentation, participants should be able to:
  1. Define and distinguish mobile medical apps (MMA) and their regulatory construct
  2. Identify challenges presented by Terms of Use agreements and Privacy Policies imposed upon research participants
  3. Discuss challenges presented in IRB review of MMAs
  4. Identify best practices in the design and use of MMAs and connected devices in clinical research 
Registration Cost: FREE to all Chapter, ACRP, and non-members

Contact hours: The Association of Clinical Research Professionals (ACRP) provides 1.0 continuing education credits for the completion of this educational activity. These credits can be used to meet the certification maintenance requirement. Membership is not required for online registration of contact hours.


To receive contact hours: Register for the event, which includes a free contact hour. Sign in at the event, and attend the program. Log on to the ACRP website then “My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Contact Hour Cost: 
Chapter Member: $0
ACRP Member: $15
Non-Member: $30

Refund Policy: Not applicable

Location

The Mez
5410 Page Road
Durham, NC 27703