Office for Human Subjects Protection Core Training - Module 8 Subject Safety

The goal of the core training modules is to cultivate advanced understanding of research topics. Each of the ten learning modules covers a different topic area.

Learning Objectives
  1. Describe methods for identifying, assessing and managing research events.
  2. Differentiate types of research events and their associated reporting requirements.
  3. Summarize types of data and safety monitoring and respective roles within the monitoring process.
Ethical and participant safety considerations
Clinical trial operations
Study and site management
Time Required
10 Learning Modules; 1 hour per module (combination of in-person & online training) available to faculty and staff at URMC
Delivery Method
Combination of online and in-person
This content was originally submitted to the Development, Implementation, and Assessment of Novel Training in Domain-based Competencies (DIAMOND) project. DIAMOND is a collaborative effort by the University of Michigan, University of Rochester, The Ohio State University, and Tufts University to provide a nationally crowd-sourced, federated, online catalog for practitioners to find and contribute training and assessment materials. If you have questions or have updated information regarding this content, please email

Submitted by CLIC Admin on Sun, 01/10/2021 - 23:11 . Last modified on 02/18/2021