Front Range Chapter: Regulatory and Legal Changes, the Common Rule, and GDPR: How they can Impact St

When:  Oct 7, 2019 from 04:45 PM to 06:15 PM (MT)
Associated with  ACRP Colorado Chapter
To purchase your contact hour, please click here.

Speaker Name:
Vice President of Audit Strategy
Cynergis Tek

Target Audience
  • CRCs
  • CRAs
  • Investigators
  • Auditors
  • Project Managers
  • Regulatory Affairs/Compliance
  • Data Managers (Site, Sponsor, CRO)
  • Medical Monitor, Medical Officer, Project Physician
  • Quality Assurance
  • Clinical Research Administrators

Program Description

The session will allow the audience to identify and anticipate compliance issues associated with the privacy concerns around the revised Common rule. It will help the audience understand the reasons why institutions may require steps to help ensure privacy that will no longer be legally required by the revised Common Rule but may be required by research institutions because of ethical concerns. It will also provide the audience with information on the privacy concerns to anticipate when research involves or could involve data covered by the GDPR.

Program Agenda
4:45-5:00 Registration and Check in
5:00-6:00 Presentation
6:00-6:15 Q & A

Learning Objectives:

• Understand the privacy implications of the revised Common Rule and CDPR on studies.
• Identify the implications of the changes to the Common Rule and the implementation of the GDPR on privacy considerations for studies.
• Anticipate why study sites might not be willing to embrace the Common Rule changes as part of their oversight, even when the Common Rule permits less oversight of studies in some instances.

1 contact hour has been approved for through ACRP. Membership is not required for online registration/application of contact hours.

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

To receive contact hours: Purchase the contact hours, sign in at the registration desk 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. After 30 days, contact hours are no longer available.

Refund Policy: No refunds will be provided unless the chapter cancels .


Online Instructions:
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Laurie Burnside