The Value of Laboratory Data and the Electrocardiogram to Protect the Safety of Subjects in Clinical Research Studies

Event Information
Product Format
Prerecorded Event
Presenter(s)
Charles H Pierce, MD, PhD, FCP, CPI
Conference Date
Tue, Aug 11, 2015
Length
90 minutes
Product Description

All You Need to Know About Regulatory Requirements for Adverse Event Reporting

 

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 and cardiovascular testing to insure investigational agent safety.

Which lab values outside of the reference range are to be reported as “adverse events” is always a question that must be answered and will be reviewed. The question of the relationship of lab data to “Adverse Event” determination is the decision of the Investigator guided by what is in the protocol.

The section on “Safety monitoring” 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. To know how to assess the single most common reason why a drug is pulled from the market after it is approved places you in a select group.

The ECG and in particular the QT interval and T wave morphology are also important, as for the data to be interpretable it must be accurate, reliable and repeatable. To know what to look for to assess “cardiotoxicity” is a plus.

Join expert speaker Charles H Pierce, MD, PhD, FCP, CPI in this informative audio session to learn the following:

  • What Lab findings to include as Adverse Events in the Safety Monitoring Plan of the Protocol
  • The Regulatory requirements of Adverse Event reporting
  • Blood Chemistry & Hematology reporting situations and how to view the “reference ranges”
  • How the ECG is used to protect product Cardiovascular safety
  • What types of studies require special attention to the Lab data
  • Importance of avoiding the error of non-inclusion with regards to safety testing
  • What are “Liver Function” tests?  
  • Why the term “Normal values” has no place in Clinical Research?
  • Why corrected QT interval (QTc) is a very inaccurate measurement with four methods of determination?

Learning Objectives (for those needing CME credits)

  • Define the Role of the Laboratory in the AE process
  • Evaluate the way one interprets Biochemistry labs
  • Compare the interpretation Hematological lab results
  • Describe how the ECG is of value to Subject Safety
  • Evaluate the scope of Cardiovascular / ECG testing

Who should attend

This webinar is intended for all personnel conducting clinical studies who have an interest in the safety of the study participants. In addition, this webinar will provide invaluable assistance to industry study sponsors of pharmaceutical product research involving human subjects. Those specifically benefiting would be: Principal Investigators and Sub investigators, Safety Nurses, Clinical Research Associates (CRAs) and Coordinators (CRCs), Recruiting staff, QA / QC auditors and staff.

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Charles H Pierce

Charles H. Pierce, MD, PhD, FCP, CPI


From an original Master’s thesis (Pharmacology) in 1961 (Minnesota) through a Doctorate in Surgery-Pharmacology in 1974 (Saskatchewan) and continuing throughout 45+ years in the practice of clinical medicine as a family physician (7 years as an ER doc) and 25+ years in the medical research industry (7 years as a Principal...   More Info
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