Quality Assurance
This section contains the following:
Introduction
The success of any clinical trial depends on the quality of the data
collected. Ensuring good quality data requires developing
extensive
and detailed quality assurance procedures such as those for monitoring
the
clinical centres; and those for assuring quality of data handling and
processing
in the coordinating centre. As in all aspects of clinical trials,
a
quality control program requires attention to detail and careful
planning.
This program should include plans for data checking (how much will be
checked
by whom, and by what method); audit trails (detailed log showing which
data
have been changed, the reason for any change, who made the change and
when);
and source verification procedures (how much data will be checked
against
source document). There should be a written description of the
quality
control program within the Manual of Operations.
During the planning of data collection and management, a number of
decisions must be made regarding quality assurance procedures, here are
some questions you might like to think about:
- Will duplicate data entry be done and, if so, where, when, and by
whom?
- Will source verification be done and, if so, where, when, and by
whom?
- Will selective verification be done and, if so, where, when, and
by whom?
- How will queries be communicated and resolved?
- What will be done with suspicious values in the interim between
identification and resolution?
- How and when will corrections be implemented and documented?
- How will training and support for data entry personnel be
provided?
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Things to consider
- Describe the steps that will ensure that manipulation or
transmission of the data produces no unintended changes.
- Those steps might include; data checking; audit trails; and
source verification procedures.
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Additional resources
This checklist has been contributed by Barbara Farrell who prepared
it for the third version of the Trial Management Guide
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This checklist has been contributed by Barbara Farrell who prepared
it for the third version of the Trial Management Guide.
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This checklist has been contributed by Barbara Farrell who prepared
it for the third version of the Trial Management Guide.
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Further reading
Baigent C, Harrell FE, Buyse M, et al. Ensuring trial validity by data
quality assurance and diversification of monitoring methods. Clinical
Trials 2008; 5:49-55.
Neaton JD, Duchene AG, Svendsen KH, et al. An examination of the
efficiency of some quality assurance methods commonly employed in
clinical trials. Statistics in Medicine 1990;9:115–124
Williams OD. A framework for the quality assurance of clinical data.
Clinical Pharmacology and therapeutics 1979: 24; 700-702
Knatterud GL. Methods of quality control and of continuous audit
procedures for controlled clinical trials. Controlled clinical trials
1981:1;327-332
Hosking JD, Rochon J. A comparison of techniques for detecting and
preventing key-field errors. American Statistical Association, 1982, pp
82-87
Mullooly JP. The effects of data entry errors: an analysis of partial
verification. Computational Biomedical research 1990; 23: 259-267
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 December 2008