This course will focus on the laws and regulations, documentations and process imposed by the Federal government especially the Food and Drug Administration related to pharmaceutical and medical device approval and the clinical trials associated with the approval process. Emphasis is placed on designing and implementing appropriate clinical trial protocol documents as well as all forms associated with the clinical trials used for evidence based documentation of the trial(s). Statistical justification will also be introduced for use as to methodology and analysis of the trial.
- Develop and implement appropriate protocol documents for initiation of a clinical trial.
- Develop study forms and clinical report forms for evidence based documentation of the clinical trial.
- Develop a standard operating procedure for all phases of a clinical trial.
- Develop a quality assurance (Q/A) and quality control (Q/C) documents.
- Apply statistical methods for justification for the trial methodology.
- Design and implement ‘ad hoc’ documents to fulfill FDA requirements for product approval from the clinical trial.
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We’re proud to be a veteran-founded, San Diego-based nonprofit. Since 1971, our mission has been to provide accessible, achievable higher education to adult learners. Today, we educate students from across the U.S. and around the globe, with over 165,000 alumni worldwide.
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