Clinical Documentation

Course Description

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.

Learning Outcomes

• 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.