GCP2: Good Clinical Practice Level 2

The second course in the Good Clinical Practice (GCP) series reviews the standards used in clinical studies from start-up to post-study audits.

After completing this course, participants should be able to:

  • Explain the role GCP plays in ensuring subjects are protected
  • List the investigator and sponsor`s responsibilities prior to study start-up
  • Describe the documents found in a study file
  • Explain the purpose of the evaluation visit
  • List the functions of Independent Review Boards (IRBs or IECs)
  • Describe the investigator-IRB interaction
  • Explain how informed consent is achieved
  • List the essential elements of the informed consent document
  • List the investigator`s ongoing responsibilities during a clinical trial
  • List the documents maintained during a clinical trial
  • Describe the interactions between an investigator and IRB once the clinical trial has commenced
  • Explain how the investigator maintains accountability of the investigational product
  • Describe how adverse events are recorded and reported
  • Explain what is meant by a “complete” record
  • Describe the types of records that must be kept following NDA approval or the termination of a clinical trial
  • Describe the process of disqualification

Our e-courses are only available for group and corporate-wide licenses. Pricing is based on the estimated number of users. Please contact us to learn more about incorporating the GxP and Regulatory Series into your corporate training program. We can also develop custom training solutions to meet your specific training needs.