FDA Clinical Trial Auditing

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Why Should You Attend: The main principle is following exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572.

In the current regulatory climate, GCP Investigator site audits are a part of the clinical trial process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site.

Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of investigators as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections.

It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. To not follow the protocol and document study conduct carelessly is folly.

Areas Covered in the Seminar:

• The Sponsor‘s responsibility in monitoring study conduct.
• Components of a sponsor monitoring system beyond SOPs.
• The nature of adequate oversight of all staff and non-staff.
• The importance of Protocol knowledge in preventing errors.
• How do sites prepare for an audit / inspection.
• The measures to ensure quality monitoring.
• The gaps monitoring systems.

Who Will Benefit:

• Sponsor Senior Management,
• Project Managers,
• CRA Managers,
• QA/Compliance persons

In CRO’s and sites, those benefiting the most would be:

• Principal Investigators and sub investigators
• Clinical Research Scientists (PKs, Biostatisticians, ...)
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting staff
• QA / QC auditors and staff.
• Clinical Research Data managers