第二军医大学卫生统计学教研室.pptVIP

Data Management Documents September, 2010 at SMMU, Shanghai Agenda Agenda 2.1 What is Data Management Plan (DMP) Synonym: Data Handling Protocol; Data Quality Plan, etc The DMP documents the processes and procedures employed by Data Management (DM) to promote consistent, efficient and effective DM activities for a specific study in order to provide a study database that is accurate, secure, reliable and ready for analysis. The contents present here are a guide only and can be customized by adding or removing sections according to company SOP/Guidance and specific study requirements. 2.2 Use and Benefits of DMP DM staff use DMP to define or further develop the procedures that describe how they manage data, to what standards and why for a specific study Through reference to the DMP, other functions will be able to understand DM requirements, which leads to improved communications between all parties concerned and more efficient and accurate data collection The DMP is an auditable document often asked for by regulatory inspectors and should be written in a manner that is professional and of high quality Agenda 3. Contents General Header Footer (page number) Cover Page Sponsor name Protocol title and number Version number of the DMP Effective date of DMP Signatures and distribution list 3. Contents Table of Contents Amendment and Change Procedures A statement of how the DMP will be followed How to handle deviation or modification to the DMP Who needs to agree them How the changes will be made How minor amendments will be made after production Definitions and Acronyms 3. Contents Case Report Forms CRF Design – Description of the CRF design process or refer to the company SOP CRF Completion Guidelines General guidelines Study-specific guidelines CRF Change Control – Description of the process for managing post-production changes or refer to the company SOP 3. Contents Database Design, Creation and Maintenance DB Name, Version, and Location DB Design – Des