How Sponsors Generate GCP Noncompliance at Investigator Sites

Why Should You Attend:

A failed FDA investigator site inspection associated with findings of critical or major GCP noncompliance may result in 1) FDA refusal to accept the submission for consideration, 2) possible FDA enforcement actions against the Sponsor and Investigator, and 3) loss of millions of dollars spent and perhaps years of time to market. Pharma management knows this.

Yet, as the study is designed and progresses the objectives of pharma clinical trial management are not always those of the FDA. Program management decisions are often focused on budgets, timelines, and the completion of subjects and data acquisition. The CRO and investigators are likely to be focused on these same objectives. The absence of sponsor focus on, and the assurance of, GCP compliance is commonly the source of noncompliance generating decision. The absence of sponsor oversight or misdirected oversight has caused many failed programs, as illustrated by the case studies discussed in this webinar.

We will review two FDA published investigator site investigations and one unpublished case where sponsor program design and conduct decisions caused program failure associated with failed FDA investigator site inspections. We will identify which of the 21 most common FDA inspectional findings of investigator site noncompliance can be associated with the Sponsor decisions. Common CRO contract clauses that can cause investigator noncompliance will be identified. The FDA mandate for oversight of clinical research will be discussed as it applies to the pharma sponsor, CRO, and investigator perspectives. Finally, a case will be presented wherein FDA rejected an application by a US Pharma company for GCP noncompliance on an international trial funded by and “conducted” to NIH standards.

“Stuff” happens in the conduct of a clinical trial that cannot be anticipated. Noncompliance at the investigator site that is generated by sponsor decisions or management is entirely avoidable.

Areas Covered in the Webinar:

• Sponsor regulatory IND obligations
• The Sponsor/CRO relationship as a factor for investigator site GCP compliance
• The sponsor/Investigator relationship as a factor for investigator site GCP noncompliance
• Seven FDA Inspectional GCP compliance objectives
• Severity assessment by FDA of noncompliance findings
• 21 most common FDA findings of investigational noncompliance
• Sponsor or investigator as the associated noncompliance cause
• Whose study is it: Application of sponsor risk management

Who Will Benefit:

• Regulatory personnel
• Clinical operations, CRA
• Director and upper level pharma research management
• Investigators and research management staff

Stephen Schwartz
Founder, Solaris Research Corporation

Steve Schwartz, is the founder of Solaris Research Corporation. He has a biology degree with a major in microbiology. He has 7 years of virology research in pharma, and moved into clinical research program administration for 6 years in the pharmaceutical industry. Entering the CRO industry, he performed clinical monitoring and clinical quality assurance field service using that expertise to achieve a management position at the director level over the next 10 years. 10 years of CRO experience culminated in the formation of his full service CRO in 1989 to 2008 , under the initial name of Commonwealth Clinical Research Corporation- later Solaris Research Corp. Steve has also served as the investigator for several phase four clinical trials. He has served on an academic IRB. After a brief retirement he worked as Senior Manager, Global Clinical Operations/ GCP in pharma. for 4 years until 2012. Escaping from the corporate environment he is again in retirement and continues to speak and consult to enable the sharing of his experience and expertise in CQA, regulatory affairs, and clinical operations including SOP, TMF, clinical monitoring, and best practices. Steve has designed basic and advanced CQA courses for delivery to Health Canada and US Government agencies, to the pharmaceutical industry, and to academic institutions. He has provided clinical program management, clinical monitoring, CQA auditing and regulatory consulting. Steve published a monthly electronic clinical trial conduct newsletter from 2000 to 2008.

Topic Background:

Investigator site critical and major GCP noncompliance resulting in FDA rejection of sponsor market approval applications can be an unintended consequence of sponsor study program design and conduct decisions. A review of these common sponsor errors will bring an awareness of the risk and liability of these decisions.

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