Training Program Title

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

CTSA Hub Administered

yes

Training Program Description

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.

Competency Keywords

Adverse event, Regulatory guidelines, Safety reporting, Data quality

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

no

Competency Domains

Ethical and Participant Safety Considerations; Clinical Trials Operations; Study and Site Management

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.

Delivery Method

Combination of online and in-person

Target Learners

Undergraduate, graduate or professional degree students; Post-doctoral scholars; Community Partners

Learning Level

Fundamental

Onboarding

yes

Frequency

Annually

Time Needed

10 Learning Modules; 1 hour per module (combination of in-person & online training) available to faculty and staff at URMC

Associated Assessment

yes

Assessment Methods

Learning outcomes

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