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Monday, June 27 • 8:30am - 9:45am
#101: Opportunities for Improving Informed Consent of Clinical Research Volunteers

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Limited Capacity seats available

Component Type: Symposium
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

Learn about new strategies for improving the informed consent process. Recommendations and tools for re-focusing on the informed consent process will be provided. Examples, opportunities and future directions related to use of eConsent will be shared. Finally, the challenges and solutions for consenting adult and pediatric patients in antibacterial clinical trials will be discussed.

Learning Objectives

Describe recommendations for improving the informed consent process in clinical research; Discuss the TransCelerate eConsent project including benefits for research volunteers as the industry moves from paper to eConsent; Recognize actions that can be taken to encourage site eConsent adoption and proactively address issues that commonly surface during eConsent site implementation; Identify opportunities for improving consent in challenging situations.

Chair

Jennifer Lentz

Speaker

Transforming Informed Consent: Initiatives of the Clinical Trials Transformation Initiative and TransCelerate BioPharma, Inc.
Jennifer Lentz

Engaging Investigators and Site Staff in Adoption and Implementation of e-Consent: A World View
Susan Brink, DrPH

Applicable Lessons Learned from the CTTI Antibacterial Drug Development Program
Pamela Tenaerts



Chair
JL

Jennifer Lentz

Global Informed Consent Consultant, Global Clinical Operations, Eli Lilly and Company
Jennifer Lentz has been the Global Informed Consent Process Owner at Eli Lilly and Company for the last 3.5 years. Currently, she is also involved in consent projects with Clinical Trials Transformation Initiative, Transcelerate, and Innovative Medicines Initiatives. Prior to joining Lilly, Jennifer worked as a study monitor, study coordinator, disease field investigator, and lab researcher. She became interested in informed consent during her... Read More →

Speakers
avatar for Susan Brink

Susan Brink

Executive Vice President, e-Consent Products and Services, Enforme Interactive
Dr. Brink has been involved in creation of e-consent since 2003. As PI on a NIH SBIR grant to develop an electronic informed consent, she led the team in vision, guidance and research for SecureConsent. Her Enforme portfolio includes expansion of SecureConsent e-consent system into use by biobanks and medical procedures.. She brings her patient education and decision making expertise to the conceptualization and development of patient education... Read More →
avatar for Pamela Tenaerts

Pamela Tenaerts

Executive Director, Clinical Trials Transformation Initiative (CTTI)
Dr. Tenaerts provides senior level oversight of CTTI and directs efforts to effectively engage all stakeholders to improve conduct of clinical trials. She is a member of PCORI's CTAP expert post-award subcommittee and MIT Collaborative Initiatives Clinical Trials Process Expert Advisory Board. With > 25 years’ experience in clinical trials, she also practiced medicine in the emergency room and private practice. She received her MD from Catholic... Read More →


Monday June 27, 2016 8:30am - 9:45am
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA