Thursday, August 13, 2009

Fundamentals of Clinical Research

The Association of Clinical Research Professionals (ACRP) has a two-day course coming up. It's called: Fundamentals of Clinical Research

Sept. 10-11, 2009, Houston, TX
Oct. 15-16, 2009, Alexandria, VA

Fundamentals of Clinical Research is designed for those who aspire to the following roles: clinical research professionals managing studies at clinical research sites or monitoring studies, product managers, clinical investigators, institutional review board members, clinical pharmacologists, and research pharmacists.

Here are the learning objectives (you can receive continuing education credits):
* Discuss the main historical events which led to the increasing regulation of the development of medicinal products, devices and biologics
* Explain the differences in the development processes for medicinal products, devices and biologics
* Identify the roles and responsibilities of clinical research professionals in the overall process of conducting a clinical trial and how each professional contributes to that process
* Apply the principles of Good Clinical Practice (GCP) in their daily functions
* Identify the main regulations which govern the practice of clinical research
* Observe the additional rules applicable to research funded by the Federal government and bodies like the NCI and NIH
* Identify ethical issues involved with conducting clinical research
* Identify the protections given to human subjects in research
* Describe the process of obtaining informed consent from human subjects
* Describe the respective roles and responsibilities of clinical research professionals notably Clinical Research Coordinators (CRCs), and Clinical Research Associates (CRAs)
* Identify and evaluate Unanticipated Problems
* Define the criteria for reporting unanticipated problems and adverse events
If you're interested in pursuing a career in clinical research, then you may want to evaluate your skills and competencies based on the learning objectives listed above. How well can you explain/identify/describe/discuss/etc. each of the points listed above?

For more information about this course, click here.

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