Get Manual Of Policies And Procedures Center For Drug ... - Fda

This guide provides users with a comprehensive overview of filling out the Manual of Policies and Procedures for the Center for Drug Evaluation and Research (MAPP 6700.2) online. It includes step-by-step instructions for each section of the document to ensure clarity and ease of understanding.

Follow the steps to complete the form effectively.

1. Click the 'Get Form' button to obtain the form and open it for editing.
2. Review the purpose section of the form and ensure that you understand the objectives outlined. This section establishes the foundation for the practices described in the MAPP.
3. Examine the background information provided in the document. This section discusses the context in which the Office of Surveillance and Epidemiology (OSE) operates and the types of data it manages.
4. Navigate to the definitions section to familiarize yourself with key terms. Understanding these definitions will aid in interpreting the policies and responsibilities associated with data management.
5. Fill out the policy section by detailing how OSE will implement quality system practices. This includes factors such as project purpose, scope, and available resources.
6. Proceed to the responsibilities and procedures section. Identify the specific responsibilities assigned to OSE analysts in managing the analytic projects.
7. Complete the quality control practices. Document your understanding of the database structure and the data content necessary for the analysis activities you will undertake.
8. Follow the quality assurance practices section, selecting the appropriate level of QA for your project. Make sure to document the QA practices implemented during your analysis.
9. Once all sections are complete, save your changes and review the form for accuracy. You may then download, print, or share the form as required.

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