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
- Briefly describe how data will be entered into the data
management system.
- Consider whether this will be performed solely by the data
co-ordinating centre and state whether data will be manually entered
(single or double) or scanned in.
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Illustrative example - Perinatal care trial
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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
This checklist has been contributed by Barbara Farrell who prepared
it for the second version of the Trial Management Guide
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This checklist has been contributed by Barbara Farrell who prepared
it for the second version of the Trial Management Guide.
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This checklist has been contributed by Barbara Farrell who prepared
it for the second version of the Trial Management Guide.
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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.