Set up the coordination centre
This section contains the following:
Introduction
Most trials require a Trial
Co-ordinating Center to handle administrative matters once participants are
being entered. This is usually the base for the Trial Management
Group. (link back to recruit staff) This
group should meet regularly e.g. weekly to ensure the efficient day-to-day
running of the trial, to prepare reports for the steering committee, and to
organize and service the data monitoring and ethics committee.
InitialCoordination and organisation tasks include; defining the space for the
coordination unit with preparation of equipment to coordinate and
manage the trial, such as computers, data collection tools.
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Things to consider
- Define the person in charge of the budget management
- Select the sites of the study and the collaborators
- Select the trial steering committee and data monitoring committee
- Select the contact with regulatory agencies
- Develop a written description of all trial management systems. This
documentation forms the Operating Procedures, often referred to as Standard
Operating Procedures (SOPS) and the Manual of Operations.
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Additional resources
Barbara Farrell. Efficient management of randomised controlled
trials: nature or nurture. BMJ 1998;317:1236–9
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TrialsCentral provides free and confidential access to listings of
clinical trials. Information about current clinical research helps
support informed evidence-based decision making in healthcare.
The RESOURCES page links to health care information sites, including
medical dictionaries, articles, and links to other evidence-based
health care sites.
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The Society for Clinical Trials, created in 1978, is an
international professional organization dedicated to the development
and dissemination of knowledge about the design and conduct of clinical
trials and related health care research methodologies.
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The UK Trial Managers' Network (UKTMN) is a forum for the people who run UK
publicly-funded trials. Its primary functions are to link trial managers
together to ensure the sharing and dissemination of expertise and experience and
to provide training tools developed by the members of the network to new trial
managers
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Further reading
Warlow CP. How to do it: organize a multicentre trial. BMJ
1990;300:180-3
Pocock SJ. Clinical Trials: A Practical Approach. John Wiley and Sons,
Chichester, 1983.
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This page was last updated September 2008.