What is the role of the Laboratory Lab Data in the Drug Development Process: Adverse Events Subject Safety

Description: 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 will benefit.