Course Description:

This course will provide understanding of the clinical site inspection process for investigator staff and sponsor support staff:

  • To understand the process and the liability
  • The appreciate the need for clinical site training
    • Unsuccessful investigator challenges to FDA authority
    • Investigator obligations
    • Sources Of noncompliance at the investigational site:, CRO , sponsor and investigator
    • How to understand the inspectional perspective/focus and process
    • How to prepare for the inspection
    • What questions will be asked and how NOT to respond
    • A case history of a clinical program inspected by FDA
    • Role playing in the interview process- learning a required skill
    • FDA suggestions to clinical investigators

Does the clinical investigator and the sponsor understand the exposure and liability to the often severe professional and financial consequences of a failed regulatory inspection of your study site-? Institutions and investigators commonly make five false assumptions:

  • That the regulatory authority cannot adversely impact the clinical investigator.
  • That the clinical monitoring functions by the CRO or sponsor provides indemnification to the investigator from a failed regulatory inspection.
  • That the CRO contracted responsibilities provide indemnification against regulatory enforcement against the sponsor.
  • That simply presenting the site master file and source docs and CRF is enough to pass” a regulatory inspection.
  • That not documenting GCP deviation will prevent regulatory observations.

It is absolutely necessary for investigational site staff to understand the focus and process of the regulatory inspection at investigational study sites.

Inappropriate investigator responses to the FDA inspectional interview process often generate 483 and other GCP non compliance observations that can initiate significant enforcement regulatory actions. The first part of this course will access the public records for examples wherein clinical investigators responded inappropriately to the regulatory agency. Several case histories of investigator site FDA inspections will also be presented.

Can the investigator avoid the very common and unnecessary escalation of minor conduct deviations to critical regulatory observations? This escalation is frequently associated with the investigator's failure to adequately prepare and present the study documentation, the investigator's failure to respond appropriately to the regulatory inspection interrogation, and the sponsor's inability or failure to support the required demonstration of investigator regulatory GCP compliance.

In conclusion - A well intentioned investigator alone does not enable a successful clinical site inspection. It is very difficult to conduct a clinical trial of any size or complexity without some level of GCP or study related deviations. An overly cooperative investigator that is not trained for the conduct of a regulatory inspection may in fact unintentionally create or escalate noncompliance findings.

Who will Benefit:

This course will benefit the investigators and site staff who will be inspected, the sponsor CRA, and institution quality staff and clinical administrators.

  • Clinical investigators and sub investigators
  • CRC, site pharmacists
  • Quality Assurance staff at investigator sites, sponsors, and research institutions
  • Clinical Research Associates

Course Outline:

Day One     Day Two

Section 1- the regulatory inspection objective

    • Challenges to FDA authority (actual examples)
    • Investigator and sponsor regulatory obligations
    • The 1572 and associated documentation
    • Limitations of regulations, GCP, and Guidance
    • Sources of common non compliance observations
    • The CRO as a resource
    • The investigator and sponsor liability
    • The FDA Inspection Operation Manual

Section 2- preparing for the inspection

    • How to address the regulatory perspective before and during the inspection
    • How to assess your GCP compliance before the inspection- know what to expect
    • Documentation concepts
    • Using the sponsor as a resource to prepare for the inspection

Section 3- The inspection- what to expect

    • Notice of inspection
    • The inspection introduction interview
    • The PI, CRC, and staff interviews- how and what questions will be asked
    • How to respond without raising new issues or escalating current issues
    • The document inspection- what to present, how, and when.
    • The exit interview- the investigators best opportunity to address inaccurate inspectional observations, and where investigators often escalate those same observations
    • The 483 process- using all resources available to respond accurately


Section 4- How Not to respond to regulatory actions

Section 5- Examples of Failed Inspections

    • A case history of a clinical program inspected by FDA
    • FDA suggestions to clinical Investigators for a successful inspection

Section 6- Participant Role Playing exercise, responding to:

    • Notice of inspection and appointment
    • Regulatory introduction interview
    • PI, CRC, or staff interview interrogation
    • Document request
    • Exit interview questions and statements
    • 483 listing

Meet Your Instructor

Stephen Schwartz
Founder, Solaris Research Corporation

STEVE SCHWARTZ, CIC; is the founder of Solaris Research Corporation, Steve has a background in basic virology research, progressing into 10 years clinical research program administration 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. 10 years of CRO experience culminated in the formation of his full service CRO in 1989, under the initial name of Commonwealth Clinical Research Corporation- now 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 for a major Pharma company from March 2008 until July 2012. The objectives of successfully completing two clinical programs, building a global clinical research function, and developing a novel therapeutic biologic agent were completed in July 2012. Escaping from the corporate environment he is again in retirement he continues to speak and consult internationally to enable the sharing of his experience and expertise in CQA, regulatory affairs, and clinical operations including SOP, TMF, clinical monitoring, best practices. Relevant to Clinical Quality Assurance.

Steve and his associates have designed basic and advanced CQA courses for delivery to Health Canada and US Government agencies, to the pharmaceutical industry, and to academic institutions. Solaris Research provided clinical program management, clinical monitoring, CQA auditing and regulatory consulting. Solaris Research published an electronic clinical trial conduct newsletter from 2000 to 2008.

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