罗氏公司数据管理应用介绍.ppt

Overview of Data Management within Pharma Development  Version: 0.2 Date: 19th January 2009 Owner: Training and Learning Framework SME Description: An overview of the Data Management function within the organization of Pharma Development Operations. 1.0 Document history 1.1 Approved by Training and Learning Framework SME Date 15th Aug 2008 Data Management Site Functional Heads (if required) Date Introduction The purpose of the presentation is to give an overview of the Data Management function within the organization of Pharma Development. At the end of the presentation the audience should be able to answer those questions: WHERE Data Management fits into Roche WHEN Data Management is involved in a Clinical Study with WHO Data Management interacts WHAT Data Management is doing HOW Data Management is done at Roche Agenda Drug development and team structure at Roche Study phases Study start-up activities Study conduct activities Study close-out activities Useful links Drug Development and Team structure at Roche Team Structure: The Life Cycle Team Team Structure: The Life Cycle Committee Team Structure: The Life Cycle Committee Team Structure: The Life Cycle Team Team Structure: The Clinical Team Team Structure: The Study Management Team Study Medication Development Study Medication Development and Team structure Clinical Team (CT) and the Study Management Team (SMT) Interaction of the Study Data Manager Study Phases Study Phases Study Phases Study Set up Activities Study Set up Activities Study Set up Activities Creation and review of protocol and CRF Once the protocol synopsis is approved by the Clinical team, the SMT is formed Starting CRF creation with synopsis, schedule of assessment and near final protocol The main purpose of Data Management protocol review is to assure that data referenced in the protocol can be accurately collected on the CRF or transferred electronically onto the Oracle Clinical database Study Set up Activities Devel