Review Article
Year: 2019 | Month: October-December | Volume: 4 | Issue: 4 | Pages: 79-82
Outline of Clinical Data Management
Gnanasingh Arputhadas
Data Support Specialist, Data Management, Parexel International, Bangalore, India.
ABSTRACT
Clinical Data Management (CDM) is a critical phase in clinical research which results in collection of reliable, high-quality and statistically sound data. It consists of three phases i.e. start up, conduct and close out.
Startup phase consists of activities like CRF creation and Designing, Database designing and Testing, Edit checks preparation and User Acceptance Testing (UAT) along with document preparation such as Data Management Plan, CRF Completion Guidelines, Data Entry Guidelines and Data Validation plan.
Conduct phase is the longest and most critical phase were Data capture, Data Cleaning, Data reconciliation, Medical Coding and Data Validation takes place with regular evaluation of data known as Interim Analysis along with documentations such as Query Management Form, Revision Request Form, Post Production Changes.
Close out phase is the success phase for Data Managers were all the clean data are frozen and locked. After the confirmation of locking all the data, it will be in Read only mode. Finally, the Database will be locked, and all the documents are archived.
Keywords: Clinical Data Management, Clinical Trials, User Acceptance Testing, CRF, Query Management, Clinical Research.