What is the role of the Laboratory / Lab Data in the Drug Development Process: Adverse Events? Subje

Feb. 28, 2012 - PRLog -- 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 a question that must be answered and will be reviewed.


Description of the topic:


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 “GLP” (21 CFR 58) or, better, certified in “GLP” is a goal to be obtained. 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.


Areas Covered in the Session:



   The purpose of the Safety Monitoring Plan in a Protocol
   The Regulatory requirements Adverse Event
   Studies requiring a
   What does the
   What is the composition
   What types of studies
   Importance of avoiding



Who will Benefit (Titles):



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



About Speaker

Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing 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.From an original Master’s thesis (Pharmacology) in 1961 through a Doctorate in Surgery-Pharmacology in 1974 and continuing throughout 40+ years in the practice of clinical medicine as a family physician (7 years as an ER doc). He has been in the Clinical Research Industry for 20+ years, Investigator and staff GCP training, and medical monitoring in both drug and device studies.