The study sponsor is responsible for the safety of subjects enrolled in their clinical trials. This includes creating Quality Management Plans that impact not only the sponsor’s conduct, but conduct at the site. In this project you will take on the role of the Sponsor controlling quality, including risk factors, to ensure patient safety & welfare. As the Quality Manager for the Sponsor you have been tasked with creating a Quality Management Plan for a current study. The protocol for the study can be found in the Clinical Research Management – Complement Materials;A Prospective, Multicenter, Randomized, Double Blind, Phase III Clinical Study to Compare the Efficacy and Safety of XYZ Versus Corticosteroid for the Treatment of Lateral Epicondylitis.

According to the ICH document: “The sponsor should implement a system to manage quality throughout the design, conduct, recording, evaluation, reporting and archiving of clinical trials.”

Sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results. Quality management includes the efficient design of clinical trial protocols, data collection tools and procedures, and the collection of information that is essential to decision making.

The methods used to assure and control the quality of the trial should be proportionate to the risks inherent in the trial and the importance of the information collected. The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures and data collection. Protocols, case report forms, and other operational documents should be clear, concise and consistent.”Sponsor’s Quality Management Plan for Study Sites in a 5 – 7 page, APA formatted paper. Cover page and reference page not included in 5 – 7 pages. Content after 7 pages will not be reviewed or graded. Make your words count. Your plan must include the following:

• Overview/Summary of the Plan
• Identification of the critical quality factors and the risk factors for each quality factor.
• Quality metrics – what are the factors (metrics) that determine quality? How do you prove quality? How is it measured?
• Risk management – including checks for quality such as audits to determine whether the site is on or off target.
• Quality Improvement – proactive steps and actions to improve quality, managing quality problems (CAPA & Root Cause Analysis)
• Safety of patients through the collection of quality clinical data.