Clinical Research Quality Management Systems

A Webinar Recorded by Nancy J Stark
15 August 2009

Customers and Products
The clinical research function should be viewed as a business within itself. Your "customers" are top management, the product development team, marketing, regulatory, FDA and foreign regulators. Your "products" are data, reports about data, and publications about data. Like any business, life is competitive. If your product is of poor quality your customer will go elsewhere; if you find other departments outsourcing clinical studies, you may have a quality problem.

Benefits of a Quality System
There are many benefits to having a quality system for clinical research: 1) managers have better control over their staff and the work product they produce, 2) professional and administrative staff have a better understanding of what constitutes a 'quality' work product, and 3) customers have a clearer expectation of what they will receive, what it will cost, and how long it will take to get it.

Learning Objective
The objective for this workshop on clinical research quality systems is to learn how to apply  quality system theory to a clinical research function.

What will we discuss?
[x] The first segment of the workshop will be a discussion of the clinical research function as a business unit and application of FDA QSR/ISO 13485 quality system theory to clinical research functions. We'll see that every aspect of quality system theory can be applied to a clinical research department, and that the benefits reaped by everyone involved are solid and worthwhile.

[x] The next segment will be a walk through the various parts of a clinical research quality system: 1) vision and mission statements, 2) management's policy regarding quality, 3) description of the quality manual, 4) job descriptions (optional), 5) standard operating procedures and work instructions, 6) regulatory matrix, 7) records and documents, 8) reference materials, and 9) professional growth and training records. We'll look at different ways to write these segments and how that impacts the work product.

[x] We'll look at the contents for the standard operating procedures and work instructions. A good set of SOPs is so much more than simply a set of procedures, it is the proprietary business operation for the clinical research function. We'll discuss the difference between SOPs and work instructions, how to write them, how to add attachments, and review key SOPs in detail.

[x] Next we'll examine how to construct a regulatory matrix (a cross-check to regulations) to assure that you have procedures in place for every regulatory, ethical, and business activity your function is expected to fulfill.

[x] Finally we'll discuss a management strategy for monitoring daily compliance to the quality system: you cannot expect what you do not inspect.

[x] The 3.5 hour lecture will be followed by a 30 minute quiz. The quiz is intended as one more learning tool and, except for one or two questions, is based on the lecture. One or two questions are application/problem solving questions to let you practice applying knowledge to a new situation. 

You will receive
[x] PowerPoint slides.
[x] An expert speaker (to her chagrin, Dr. Stark has nearly 30 years experience.)
[x] Selected SOPs.
[x] An example regulatory matrix.
[x] A chance for Q&A.
[x] 0.4 CEUs and Certificate of Attendance for registered learners.
[x] The opportunity for colleagues to audit the event.

Please note: CDG's model Clinical Research Quality System may be purchased separately and is not required for the workshop.

Audience suitability
[x] People who manage clinical research functions.
[x] Clinical research professionals who want a better understanding of their roles.
[x] Quality system managers who want to apply quality theory to specific functions.
[x] Anyone who will audit a clinical research function.
[x] Top management.

Presenter
The workshop will be presented by Dr. Nancy J Stark. 

System Requirements
[x] Personal computer
[x] Speakers or headphones
[x] CD drive

I look forward to 'seeing' you there! Nancy