Data management system

This section contains the following:


Whenever possible, trials should use a computerised system for data management.  Such computerised systems are useful to keep track of the flow of participants in the trials (e.g. recruitment, withdrawals, reason for withdrawals, data collection, and for recording the flow of information to/from participants (e.g. questionnaire despatch/return)).  These systems also enable quick and efficient data validation and quality control and may also be used to set up standardised management reports for the Trial Management Groups (see Trial management). 

An effective data management system needs to be flexible and adaptable, so that it can be tailored towards the needs of the people collaborating in the trial.  For larger trials this may be a customised programme, but smaller trials may adapt off-the-shelf software.  The most suitable data management system will depend on budget constraints, the complexity of the trial and the technical environment.  Asking the advice of an experienced trial programmer can be invaluable in helping to choose the right system.  Before choosing a system considering the following questions may be useful:

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Things to consider when writing a protocol

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Illustrative example - Perinatal care trial

Appendix 1 contains the specifications for the development of the software package that will be used to implement data collection procedures at the hospitals level and at CLAP data center (see Example Data Management Systems Specifications ).  The system will have six modules: Data Entry, Data Validation, Data Transmission, Security, and User Management (see Example Data Management Systems Components ).

Each hospital in the study will have a computer with the data management system (DMS) installed and access to e-mail.  At CLAP headquarters, a server and two terminals will be available for the study, equipped with the full version of the DMS. SPSS statistical software will be used for data analyses.  The server will be provided with an uninterruptible power supply (UPS) and a disk array and backup system to assure data integrity.
(CLAP Trial - go to protocol)

go to protocol )

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Additional resources

PSt resource icon Checklist for data backup and storage

This checklist has been contributed by Barbara Farrell who prepared it for the second version of the Trial Management Guide.

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PSt resource icon Example data management system components

This figure was contributed by Eduardo Bergel who prepared it for the CLAP Trial.
A picture of a data management system

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Trial Protocol Tool resource icon Example data management system specifications

This appendix was contributed by Eduardo Bergel who prepared it for the CLAP Trial.

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Web resource icon Epi Info

Epi Info is a public domain software package designed for the global community of public health practitioners and researchers.  It provides for easy form and database construction, data entry, and analysis with epidemiologic statistics, maps, and graphs.  The primary applications within Epi Info are:

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Further reading

Seibel R: Data entry devices and procedures. In Van Cott HP, Kinkade RG, eds.  Human engineering guide to equipment design. Washington, DC, US Government Printing Office, 1972

Hosking JD, Newhouse MM, Bagniewska A, et al. Data collection and transcription.
Controlled Clinical Trials 1995;16:66S–103S.

Pocock SJ. Clinical Trials: A Practical Approach. John Wiley and Sons, Chichester, 1983.

Duley L and Farrell B.  Clinical Trials. London: BMJ Books, 2002.

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This page was last updated 18th April 2005.