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Mercure Hotel Amsterdam City

2019年12月04日 (水) 午前 8:00 - 2019年12月05日 (木) 午後 5:00

Joan Muyskenweg 10, 1096 CJ Amsterdam, Netherlands

Clinical Trial Disclosure & Data Transparency Conference

Evolving Requirements and New Challenges

Session 6: Sharing of Individual Patient Data From Clinical Trials ICMJE Data Sharing Requirements: Implications For Clinical Trial Sponsors

Session Chair(s)

Kathy  Thomas-Urban, PhD

Kathy Thomas-Urban, PhD

Medical and Scientific Writer

Medical & Technical Writing & Publication Services, Germany

Various data sharing initiatives are prompting trial sponsors to share clinical data in the public domain. Indeed, some ICMJE member journals have stated that lack of a positive data sharing statement, upon submission of the manuscript, will prevent manuscript acceptance for publication. The EU General Data Protection Regulation (EU GDPR) is also influencing the data sharing environment, especially for rare diseases. Concepts regarding data sharing that are part of the considerations for sponsors of clinical trials include: i) processes and conditions that could be used to share data including the impact of GDPR, and ii) types of collaborative research that could evolve through data sharing. Sponsor preparedness for data sharing should be an essential component at the early stage of clinical trial planning. This implies communicating and explaining the data sharing requirements within the organization as well as revising internal processes and procedures for data sharing of clinical data.

Speaker(s)

Kathy  Thomas-Urban, PhD

ICMJE Data Sharing Requirements: Brief Overview

Kathy Thomas-Urban, PhD

Medical & Technical Writing & Publication Services, Germany

Medical and Scientific Writer

Slavka  Baronikova

Scientific Collaboration and Data Sharing

Slavka Baronikova

Galapagos NV, Belgium

Director, Scientific Publications

Grant  Strachan, LLM

ICMJE Data Sharing Requirements and EU GDPR

Grant Strachan, LLM

Brodies LLP Solicitors Capital House, United Kingdom

Senior Associate, Regulatory

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