Data entry

This section contains the following:


Introduction

Data entry is the process of converting information, whatever the original source, to an electronically stored form so that it can be managed and analysed with the help of computers.  The most common data entry method is the transcription of information from a paper form (such as a questionnaire) by manual entry into a file using a computer software package.  Data entry can be performed by a single person (single data entry) or entered twice by different people (double data entry).  The most appropriate software to store and manage data is called a database management system (see Data management system).  More recently, modern technology has permitted the replacement of the manual data entry phase by a ‘data capture system’.  In this approach the data is either scanned in electronically or entered directly into a computer e.g. use of Personal Digital Assistants or Web.


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Things to consider when writing a protocol


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Illustrative example - Perinatal care trial

Every morning, the data clerk at the hospital level will collect all CLIN forms for deliveries of the previous day and all ALTA forms for all women that were discharged from the hospital that day.  The data manager will then enter the data in the Remote Data Management Subsystem (RDMS) for that hospital.  The RDMS is a standalone application that runs on a personal computer.  Consistency checks are performed during data entry and warnings are displayed.  The data is checked to make certain that entered values are acceptable, that all required fields are entered, and that items are consistent with other related items in the database. 

(CLAP Trial - go to protocol)


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Additional resources

PSt resource icon Checklist for data entry

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 Checklist for double data entry

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


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Trial Protocol Tool resource icon Checklist for data checks

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


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Trial Protocol Tool resource icon The advantages and disadvantages of data entry methods

This table has contributed by Alan Young, CTSU, Oxford who prepared it for the fifth annual meeting of the MRC Trial Managers Network


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Further reading

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

Gibson D, Harvey AJ, Everett V, et al. Is double data entry necessary? The CHART
Trials. Controlled Clin Trials 1994;15:482–488.

Reynolds-Haertle RA, McBride R. Single vs. double data entry in CAST. Controlled
Clin Trials 1992;13:487–494.

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.