Management, analysis, and reporting

Data Management, Analysis, and Reporting Alternatives for Laboratory Instrumentation... 

Since we are a research center, many of our requirements are unique and evolving. Therefore, although we favor use of commercial specific/bundled systems where possible, we are more often than not funneled into the in-house option. The software system designed and written in-house and which is adapted for most of our applications is called MARS, an acronym for Management, Analysis, and Reporting System. 

SAS has always had and will maintain a central role in the data management, analysis, and reporting of clinical trial data. Because of the strong suite of SAS statistical procedures and the power of Base SAS programming, SAS remains a favorite of statisticians for the analysis of clinical trial data. Several companies have built their clinical trial data management and statistical analysis systems entirely with SAS software. More recently, SAS has offered SAS Drug Development as an industry solution that provides a comprehensive clinical trial analysis and reporting environment compliant with 21 CRF-Part 11. 

Sometimes the blind review can throw up data issues that require further evaluation by the data management group with data queries being raised, and these perhaps may result in changes to the database. This sequence of events can cause major headaches and delays in the data analysis and reporting, and so it is important in the planning phase to get the data validation plan correct so that issues are identified and dealt with in an ongoing way. 

The model for an analysis and reporting strategy presented emphasizes the importance of a structured plan of work in combination with team s commitment, in the attempt to complete participation in the OPCW proficiency-testing scheme successfully. However, teamwork among laboratory staff may not be enough successful participation requires full support from management too. After all, management must understand that participation requires full devotion from the laboratory other tasks preferably have to wait for a later point in time. 

At study completion, the data manager is responsible for assuring that the data are clean and then prepares to lock the study/close the database. The purpose of locking the study is to ensure that a full audit trail of any changes exists once the study/patients have been unblinded. Database closure marks the end of the study conduct phase and the beginning of the analysis and reporting phase. The standard definition of clean data is ... 

A well-designed data management system typically will focus on the primary objective to facilitate the collection and cleaning of clinical data. Although it must also support analysis and reporting, it is not always possible to achieve an equal balance across all these requirements therefore, data are usually analyzed outside of the clinical database. 

Safety Management Metrics, Analysis and Reporting Tools... 

Data management falls under two levels of control. The first is the actual collection, analysis, and reporting of data the second is GLP considerations. 

As with audits, survey results form the basis of a facility-specific report for circulation to facility management and the PSM team. This report may follow the questionnaire format, with responses tabulated and analysis and commentary provided at the end. If necessary, baseline PSM assessments can be performed by a single individual using a survey method. 

For purposes of this paper, the term "Data System" will refer to computer software designed to acquire data from an instrument or laboratory process, to manage and access that data, to analyze the data as required, and to plot and report the data and analysis results. 

MARS provides the foundation of data management and reporting on which specialized analysis modules can be built. This represents a more efficient utilization of software resources and facilitates co-reporting and coplotting of results. 

The MARS software is adapted and compiled specifically for a given application. The software is organized into modules which can be interchanged as needed for a particular implementation. Most modules comprise a core of management, analysis, reporting, and plotting functions which are used for every implementation. For each application, a data acquisition module is adapted to suit the appropriate instrumentation. In addition, specialized analysis programming is added if required. The acquisition module, the core modules, and the specialized analysis modules, if any, are then linked into a customized application specific version of MARS. 

---