What is the role of the Laboratory Lab Data in the Drug Development Process: Adverse
Events Subject Safety
All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall
research plan / protocol.
This "plan" is to ensure the safety of participating subjects and to ensure the validity and
integrity of the data. 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.
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, or certified
in, "GLP" (21 CFR 58) is the goal. Trusting the reference ranges and the data to be reviewed
should give assurance as to the verity of what is observed.
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. Therefore, careful consideration of what to
include as safety data and guidelines for interpretation are important elements of a good protocol.
It is also important to see what the FDA regulations and the ICH GCP recommendations are in
regard to Adverse Events.
Why Should you Attend:
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 the question.
Objectives of the Presentation:
The purpose of the Safety Monitoring Plan in a Protocol
The Regulatory requirements of Adverse Event reporting
Studies requiring a specific type of Lab test
What do the “reference ranges” tell us?
When would an “out-of-range” lab value be an Adverse Event?
What types of studies depend on Laboratory and other testing?
Importance of good medical judgment in the process
Who can Benefit:
Those benefiting the most would be the Principal Investigators and sub investigators, Clinical
Research Scientists (PKs, Biostatisticians, ...), Safety Nurses, Clinical Research Associates
(CRAs) and Coordinators (CRCs), Recruiting staff, QA / QC auditors and staff, & Clinical
Research Data managers In addition, the holders of the IND for new products i.e. the Sponsors