Standardization across sites
This section contains
the following:
Introduction
Most trials involve more than one clinical site. In a pragmatic
trial, some variation in the delivery of the intervention at each site
is to be expected; however, some level of standardization is needed
across sites to ensure that the protocol can be executed as intended
and prescribed.
Back to top
Things to
consider
- Establish a coordinating center that has primary control of the critical functions: study design; protocol
development; recruitment; training; randomization; data management;
trial monitoring and reporting; performance monitoring of sites;
finances, equipment, drugs etc.
- Visit each clinical site before recruitment and train local staff in the protocol and delivery of the intervention.
- Ensure regular communication channels (e.g.weekly email reports)
are set up between the coordinating center and clinical sites to allow
problems and queries to be resolved quickly.
- Have tested and proven reliable information systems(forms,
laboratory data, clinical data) within each site that can feed into the
centralized information system.
- Have regular management meetings and inform centers immediately of any changes in procedures.
- Keep a trial dairy (could be the minutes of the management team meeting).
- Monitor progress in sites regularly and investigate any
unusual patterns in center performance e.g. centers that display higher
than expected rates of treatment not as randomized.
Back to top
Additional resources
Checklist developed by Carl Lombard detailing the importance of standardization across sites
Back to top
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.
Back to top
This page was last updated March 2009.