Clinical development plan data management

To develop a data management plan pertinent to the project, a checklist of the project material is necessary to enhance the planning. The items to be collected include the protocol, annotated case report forms (CRFs), literature, log-in and tracking forms, file structures, coding rules, CRF review conventions, query handling procedure, required edit checklist, central laboratory address/file format, laboratory normal ranges, clinically... 

From the data management perspective, the clinical data coordinator (CDC) is the central team member receiving and distributing data-related information to the project team members. The CDC meets with the project team members to review the project material collected and to elicit the rules and special requirements from the statistician, clinician, safety officer, medical writer and regulatory associates. These project materials, rules and special requirements will be considered in conjunction with data management requirements to develop the data management plan. The CDC should prepare the following documents before the clinical trials are initiated ... 

In order to reduce unnecessary data queries, the statistics group should be consulted early in the clinical database development process to identify variables critical for data analysis. Optimally, the statistical analysis plan would already be written by the time of database development so that the queries could be designed based on the critical variables indicated in the analysis plan. However, at the database development stage, usually only the clinical protocol exists to guide the statistics and clinical data management departments in developing the query or data management plan. 

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