Course Overview

This course addresses clinical trial management issues and skills needed to effectively conduct clinical trials. Key course factors include investigator selection and responsibilities, clinical research protocol, data management and adverse event reporting. Participating in this course will help the learner to efficiently conduct safe clinical trials that are in compliance with GCP regulations and guidelines.

You should expect to spend approximately 4 hours of study time to complete the course.

Course Objectives

  • Identify the sponsor’s responsibilities in a clinical trial.
  • Discuss key considerations when selecting a Principal Investigator.
  • Describe the key elements for protocol development.
  • Discuss issues central to data management in a clinical trial.
  • Identify actions that must be taken when an adverse event is reported.
  • Explain the FDA inspection process and identify areas of common deficiencies.

Who Should Attend

  • Study site investigators
  • Site monitors and auditors
  • Research nurses
  • Regulatory affairs associates
  • Data management personnel
  • Pharmacists

Download Course Outline

  • Sponsor Obligations
  • Protocol Development and Content
  • Data Management
  • Adverse Event Reporting
  • Investigator Responsibilities

This course is currently under review for reaccreditation and is not accredited at this time.

Minimum Hardware Requirements
Windows 98/2000/NT/XP
Mac computer with an Intel processor
Pentium III processor at 500 MHz
128 MB RAM

Minimum Software Requirements
Web browser such as Google Chrome, Internet Explorer 6+, Safari
Adobe Acrobat Reader and Flash plug-ins
Access to the Internet with any connection 56K or above

PERI, Inc. is the sole owner of the information collected at various points on this site. We will not sell, share, or rent this information to others in ways different from what is disclosed in this statement.

Course Details

Second Course in the Good Clinical Practices for the Clinical Research Team Series (see overview)
2-Month Access
Single Price: $320.00

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Contact one of our course instructors to ask a specific question about the program.
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Our Students

  • 1 “This information will allow me to ask more questions and understand the processes behind our practices.”

  • 2 “From the information in this course, I will try to focus clinical terms on designing studies that are more focused on specific patient populations.”