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Monday, February 3, 2014
5:30 - 8:00 pm

Tools for Trainers: Clinical Research Job Aids and Checklists

As adult learners, clinical research professionals are motivated by an understanding of how training interactions directly impact their work lives. The use of job aids and checklists can serve to satisfy this need by providing a resource to someone performing a task exactly when and where they need it. These tools can also serve to reinforce the training as participants return to the workplace, resulting in a greater likelihood that the organization’s performance goals will be met. In some cases, a job aid alone can replace unnecessary training expenses. This course includes a decision-making framework about the use of job aids as standalone training objects versus as a complementary tool to existing training programs. Sample tools that may be appropriate for various clinical research audiences will be discussed.

Karen Gilbert, Clinical Trainer and Curriculum Manager, Barnett International

* Separate registration required


Wednesday, February 5, 2014
6:00 - 8:30 pm

What the Warning Letters Tell Us: Recent Trends in Noncompliance

As the clinical research environment evolves in response to both internal and external changes, regulatory agency communication appears to be focused on particular areas of GCP compliance. Recent findings for Clinical Investigators, sponsors, and Institutional Review Boards (IRBs) tend to reflect historic areas of noncompliance; however, more attention is being placed on ensuring that corrective and preventive action plans, including training, are developed to secure compliance. This course will examine the trends in recent regulatory communication and will include open discussion for review of acceptable versus unacceptable responses.

Elizabeth Ronk Nelson, Clinical Trainer, Barnett International; Principal, Regulatory Risk Management, LLC

* Separate registration required

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