Criticality of Laboratory Data - including EKG - in the Drug Development Process

    /Charles H.  /Piercespeaker of compliance global
    Speaker: Charles H. Pierce
    Duration: 90 Minutes
    Product Code: 700002
    Level: Intermediate
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With the increasing frequency of real-time FDA audits and complexity of Investigational Medicinal Products (IMP’s), the wise are paying more attention to including a full range of lab tests to insure IMP safety.

Which lab values outside of the Reference range are to be reported as AE’s is always a question that must be answered and will be reviewed. The question of the relationship of lab data to “FDA Adverse Event reporting system” determination is the decision of the Investigator guided by what is in the protocol.

The section on “Safety monitoring systems” includes the array of lab tests taken at prescribed intervals adjudged to answer the safety questions. Whereas evaluation of this safety data is the Investigators responsibility, it is essential for the whole team and the sponsor to be on board with the timing and extent of this testing.

The source of lab data is also important, as for the data to be interpretable it must be accurate, reliable and repeatable. For this reason the choice of a lab following the principles of “GLP” (21 CFR 58) or, better, certified in “GCLP” is a goal to be obtained.

why should you attend

Unless you have extensive experience in lab data interpretation including cardiac monitoring, an overview of how best to view safety data would be very welcome indeed.

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Areas Covered

  • Usefulness of Lab Testing
  • The Role of the Laboratory in the AE process
  • What to include as AEs in the Safety Monitoring Plan in a Protocol
  • The Regulatory requirements of AE reporting
  • A review of Blood Chemistry reporting situations
  • A review of Hematology report issues
  • Other results from the Lab and how they are used
  • What types of studies require special attention to the Lab data
  • Importance of avoiding the error of non-inclusion with regards to safety testing

Learning Objectives

  • Demonstrate the Role of the Laboratory in the AE process
  • Identify the True ‘Liver Function’ tests and the ‘Liver Injury’ markers
  • Recognize how to interpret Hematological lab results
  • Describe what the Urine exam tells us
  • Compare Liver Injury testing with Cardiovascular / EKG testing


  • Pharmaceutical, Biological and Device Companies with an active pipeline of products and planning on global studies Principal Investigators and sub investigators
  • Clinical Research Scientists (PKs, Biostatisticians) Research Managers
  • Safety Nurses
  • Clinical Research Associates (CRAs)
  • Clinical Research Coordinators (CRCs)
  • Recruiting staff
  • QA / QC auditors and staff
  • Study Monitors
  • Clinical Research Data managers


Charles H. Pierce, MD, PhD, FCP, CPI Has 25+ years experience in the Clinical Research field. He now brings the message (via webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. He has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.

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