verview
With the increasing frequency of real-time FDA audits and complexity of Investigational Medicinal Products (IMP), 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 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.
verview
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.
verview
With the increasing frequency of real-time FDA audits and complexity of Investigational Medicinal Products (IMP), 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 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. will be held in New hyde park,United States on date 2015-03-03