EDUCATION & TRAINING

Reporting

The Reporting Course Offerings will cover a variety of topics related to reporting, in relation to institutional policies and external oversight entities.

Registration:

Please register for any sessions you would like to take. You can register by clicking the date below or by visiting the registration site. (Click here for step-by-step instructions on using the Registration System.) Unless otherwise noted, each session will be 50 minutes long.

A Map to the room can be found by clicking on the room number below

LEVEL 1 Adverse Events and Other Reportable Information or Occurrences

Course Objectives: You will learn about Adverse Events and ORIOs and how to report them

Presenter: Robin Sedman, MSN, M.Ed, Senior Associate Regulatory Analyst

Recommended: N/A

Related Workshops:

CE Credit: Not Offered

   
   
         
LEVEL 2 Study-Specific Adverse Events

Course Objectives: You will learn which studies may be able to create a study specific AE reporting plan that will allow them to delay reporting or not report specific events.

Recommended:

Related Workshops:

CE Credit: Not Offered

   
  Avoiding Non-Compliance

Course Objectives: In this class, we will explore some of the common errors made during research projects and provide solutions for avoiding such non-compliance.

Presenter: Georgia Marvin, JD, Compliance Coordinator

Recommended:

Related Workshops:

CE Credit: Not Offered

   
         
LEVEL 3 Data Safety Monitoring Boards and Data Safety Monitor Plans

Course Objectives: You will learn how to develop a DBSP and when studies should or are required to have a DSMB.

Recommended:

Related Workshops:

CE Credit: Not Offered

   
         
LEVEL 4 Audits

Course Objectives: How to Prepare and What to Expect in an Audit.

Recommended:

Related Workshops:

CE Credit: Not Offered

 
         

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Page Created on 4/2/12; Updated 4/24/12