How Sponsors Generate GCP Noncompliance at Investigator Sites

Stephen Schwartz

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Attend this webinar to explore some of the common sponsor errors. Become aware of the risk and liability of these decisions. Learn how to get approvals of submission, prevent enforcement actions, and loss.

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We will review two FDA published investigator site investigations and one unpublished case where sponsor program design and conduct decisions caused program failure associated with failed FDA investigator site inspections.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
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Speaker: Stephen Schwartz,

Stephen Schwartz, CIC is the founder of Commonwealth Clinical Research Services (later as Solaris Research Corporation), a full service CRO from 1989 to 2009. Steve worked in clinical project development for Pharma for 16 years and for 20 years as a CRO with experience in devices, biologicals, diagnostics, and therapeutics in most of the clinical indications for all study phases, as well as pre-clinical activities. Steve has extensive field experience as a CRA and as a CQA auditor, He has demonstrated expertise in Clinical Operations, including the functions of clinical monitoring, program management, product development, CQA, and inspectional operations. He has recently retired from Pharma where he was Sr.Manager, Global Clinical Operations. His current projects as a consultant include CQA inspections and training, Gap Analysis Audits, and Clinical Project Oversight for an international Pharma program.


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