Clinical Trials and Human Research: Complying With Regulatory Obligations
Requirements for Informed Consent, Disclosures, Data-Sharing, and More
Recording of a 90-minute CLE video webinar with Q&A
This CLE course will guide counsel on navigating regulatory changes for clinical trials and human subjects research. The panel will examine the practical impact for those sponsoring, conducting, or otherwise involved with clinical trials, as well as outline compliance strategies to meet the new requirements.
- Regulatory landscape for clinical trials and human research
- GDPR compliance
- The practical impact of organizations sponsoring, conducting, or involved in clinical trials or human research
- What providers and counsel need to do to ensure compliance
- Informed consent
- Data sharing
- Secondary research
The panel will review these and other key issues:
- How do recent regulations change the requirements for clinical trials or other human subjects research?
- What will the practical impact be on organizations involved in clinical trials or other human subjects research?
- What must organizations sponsoring or conducting clinical research do now to ensure compliance with the rules?
Ropes & Gray
Mr. DiMaio advises healthcare providers, pharmaceutical and medical device manufacturers, and other healthcare... | Read More
Mr. DiMaio advises healthcare providers, pharmaceutical and medical device manufacturers, and other healthcare organizations regarding a broad range of transactional, regulatory, compliance, and financing issues. He is a frequent author and lecturer on issues related to clinical trial data and GDPR among other topics.Close
David Peloquin, J.D.
Ropes & Gray
Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the... | Read More
Mr. Peloquin works with the firm’s Corporate Department, primarily on healthcare matters, and particularly in the area of clinical research and health data privacy. Prior to attending law school, he worked as a project manager for a leading supplier of electronic medical records. Mr. Peloquin is a frequent author and lecturer on clinical research/human subject protection issues, among others.Close