MGH Research Institute

Sponsored by the MGH Division of Clinical Research, the Partners Human Research Office (IRB) and the Partners Human Research Quality Improvement Program (QI).

Speaker: Isabel Chico Calero, QI Program Regulatory Specialist

You are working on an exciting new study. Are you taking the proper steps to ensure adherence to the IRB approved protocol throughout the study? Even with the most seasoned clinical research team, protocol deviations occur from time to time. If a deviation occurs, do you know your reporting responsibilities? This lecture will be useful for both new and experienced research staff.

In this session, participants will:
• Become familiar with the common protocol deviations that QI sees regularly when conducting audits and how to avoid them.
• Gain a solid understanding of what the reporting requirements are when a deviation from the IRB approved protocol occurs.
• Learn about tools and good study management tips to avoid protocol deviations.

This session is limited to 25 participants to facilitate interaction.

Registration is required. Please contact Tiereny Morrison-Rohlfs at tmorrison-rohlfs@partners.org with any questions.

---

Programs: Beginner Clinical Research Coordinator Clinical Research Investigator

Categories: Clinical Research Research Quality Improvement

Sponsor: MGH Division of Clinical Research