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Bethesda North Marriott Hotel and Conference Center

2019 年 02 月 11 日 7:00 下午 - 2019 年 02 月 13 日 8:15 下午

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 7: Track 3: eConsent: Permission to Adopt!

Session Chair(s)

Betsy  Fallen, RN

Betsy Fallen, RN

Consultant

BAFallen Consulting LLC, United States

Informed consent is one of the biggest challenges facing clinical trials. The opportunity to digitize the IC and manage it electronically offers many advantages. The panel of key stakeholders will share their experiences and answer your questions.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize the challenges that drive adoption of eConsent.
  • Identify the pros and cons for clinical sites to participate in a trial using eConsent
  • Describe the lifecycle of the documentation of eConsent.
  • Evaluate the ROI of implementing eConsent.

Speaker(s)

Sandra  Sanford, MSN, RN

eConsent: An IRB’s Perspective

Sandra Sanford, MSN, RN

Advarra, United States

Director of Quality Control

Mark  Gregorio, MSN

Electronic Informed Consent Use in Phase I Clinical Research Units

Mark Gregorio, MSN

Pfizer, Inc., United States

Michael  Tucker

The State of eConsent

Michael Tucker

Medidata, a Dassault Systèmes Company, United States

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