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Protocols, Research Participants, and Safety in the Context of War

Complimentary for DIA members, this global webinar series shares the clinical trial challenges in Ukraine and the region. Join us to create strategies for the future.

概要

The conflict in Ukraine has raised questions about the protection of patients and study staff in ongoing trials in the region, including clinical trial personnel at study sites and those working for contract research organizations and sponsors. Moreover, the disruptive events have impacted data collection, monitoring, and storage, raising challenges about how to ensure drug safety signal detection and that study participants continue to contribute to overall safety and efficacy data for the study drug.

In this webinar the patient perspective on these topics and the importance of clinical research will be shared. Additionally, the important role of CROs in maintaining clinical research in Ukraine will be explored. Challenges and solutions of ensuring trial participant safety will be presented. The value and contribution of continuing clinical trials in Ukraine to sponsors, regulators, and the international patient community will be discussed.

Additionally, during this last webinar in our 6-part series in partnership with the Ukraine Clinical Research Support Initiative (UCRSI), we will review key concepts related to safety that have been raised in prior webinars in the series. These webinars include response from the regulatory community, ethical dilemmas, considerations for maintaining good clinical practice and the role of the cancer research enterprise in rebuilding for the future.

In collaboration with Ukraine Clinical Research Support Initiative (UCRSI)

This Webinar will be one hour in length followed by 30 minutes of member discussion where we welcome our attendees to turn on their camera, unmute their microphones, and share their thoughts/ask questions. We hope you can join the conversation about this important topic.

NOTE: This webinar is exclusive to DIA members only. To register, become a member, here.




参加対象

Professionals involved in:
  • Clinical Data Management
  • Clinical Data Management/eClinical
  • Clinical Research
  • Good Clinical Practice
  • Medical Communications
  • Patient Engagement
  • Regulatory Affairs
  • Research & Development
  • Quality Assurance, Control
  • Strategic Planning

学習目的

At the completion of this activity, the participants should be able to:

  • Describe the patient perspective on research participation during a conflict situation
  • Discuss actions that can be implemented by a CRO in assuring patient safety
  • Summarize challenges and solutions related to data collection and integrity

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