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CDER Small Business Webinar | BioQuality.biz

Building Quality into Clinical Trials – an FDA Perspective

FDA has made slides available from a recent CDER Small Business Webinar titled Building Quality into Clinical Trials – an FDA Perspective. Topics covered during the webinar include:

• Background – why we are talking about “building in quality”?

o Increasing concerns regarding the safety of medical products

o Increasing complexity of medical products and studies

o Multisite, international studies

o Recognition that we cannot monitor or inspect in quality

• Objectives and responsibilities of FDA’s bioresearch monitoring (BIMO) program

• The Quality Systems Approach

• Elements of a quality system – and how they are related to FDA regulations

o What is “Quality”?

o What are the elements of a quality clinical study?

• Building in quality from the start – and improving on-going studies

• Clinical Trial Transformation Initiative (CTTI)

Some salient points made during the webinar:


o Generally inspects after studies completed, though they are shifting more resources to “real-time” inspections

o Inspects selected study sites – may not be able to extrapolate findings to overall study

• There is a shared responsibility for quality, but the quality systems approach emphasizes the responsibility of management at the sponsor

• Quality is the ability to:

o Effectively and efficiently answer the intended question about the benefits and risks of a medical product (therapeutic or diagnostic) or procedure

o While Ensuring protection of human subjects

• Adequate Monitoring by the sponsor involves:

o Assuring investigators’ compliance with the investigational plan and regulations

o Reviewing adverse events and determine impact on continuation of the study

o Assuring investigators collect and maintain current, complete, and accurate data

• Suggestions for a quality study – the regulations and beyond:

o Select qualified investigators

o Assure protocol & data requirements optimized

o Provide adequate training

o Stress importance of informed consent process

o Ensure adequate monitoring

o Ensure investigator compliance

o Ensure any and all contracted 3rd parties comply with the appropriate regulations

To read a brief description of the webinar, and to view or download the 46 slides see the links here: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm303135.htm

BioQuality: what you need to know, when you need to know it: www.bioquality.biz


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