Educational Platform for Clinical Research Associates

Abstract

The National Institutes of Health (NIH) defined clinical trials as “research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision making” (Clinical Trials. (n.d.) NIH- National Heart, Lung, and Blood Institute. Retrieved from https://www.nhlbi.nih.gov/studies/clinicaltrials). Research is the primary purpose for a clinical trial. The Food and Drug Administration (FDA) mandates that clinical trials enforce strict scientific standards to ensure patient safety while produce reliable data and capturing complete study results (Code of Federal Regulations ICH Guidelines, 2004). There are two components to this project. The first component is to develop an assessment program for Clinical Research Associate’s (CRA’s) knowledge and skill level when entering into employment with Cesca Therapeutics Inc. The newly hired employees will have their clinical research knowledge as demonstrated by completing an entrance exam and demonstrated score with a minimum passing grade of 80%. The second component is to develop an educational session for those employees who do not successfully pass the entrance exam. It is the goal of this project to create a quality training assessment while ensuring the competencies of the newly hired CRA’s.