2014 - How sponsors generate GCP noncompliance at their investigator sites

Instructor: Stephen Schwartz, CIC
Description:
This course will demonstrate that many of the 21 most common FDA observations of noncompliance at investigator sites relate, not only to the investigator, but directly to sponsor clinical research and clinical operations procedures. Multiple case history examples will be discussed. Many of these observations of noncompliance could have been prevented or remediated by appropriate sponsor procedures if they had been applied to the investigator's conduct of the clinical trial.
50% of all FDA inspections yield critical or major investigator site GCP noncompliance that places the study data at risk for being rejected by FDA when submitted in a marketing application. Investigators seldom intentionally generate this GCP non compliance. Sponsors, directly cause or indirectly enable these very real risks to the acceptance of the study data by FDA. Recognition of the sponsor activities that can generate GCP non compliance at the investigator site is prudent risk management.
Why Should you Attend:
GCP Non Compliance at the investigator site remains the sponsor's primary liability for the rejection of the regulatory application. Risk management is the operative system in the pharmaceutical product development process. Fifty percent of all FDA study related investigational site inspections incur some level of critical or major GCP noncompliance observations.
Objectives of the Presentation:
We will identify and discuss these sources of investigator site GCP non compliance
Sponsor CRO selection, contracts, and management
Sponsor program and protocol design
Sponsor, CRO, and Investigator clinical trial perspectives often not that of FDA to guarantee acceptance of the study data
What FDA expects for acceptance of the study data/marketing application?
The seven universal GCP regulatory compliance inspectional objectives
How the 7 regulatory GCP compliance objectives relate to the 21 most common FDA observations of investigator site non compliance?
Which of the 21 FDA noncompliance observations typically are caused by or included in the FDA sponsor obligations? Whose study is it?
FDA expectations for GCP compliance and specific sponsor responsibility.
Which common sponsor clinical operations procedures can cause these clinical trial risk factors?
Specific sponsor practices that directly cause investigator site non compliance.
Potential FDA actions against the sponsor or investigator- exposure, liability, and risk
How SOP and Best Practices impacts Sponsor "Due Diligence" in reducing the FDA impact of noted inspectional observations?
Who can Benefit:
Clinical Project/program managers
CRA
Clinical Quality Assurance Auditors
Clinical Investigators
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