Guidelines for conducting A Multicentric trial

A multicentric trial is conducted simultaneously by several investigators at different centre’s following the same protocol and proformae. Ideally, these trials should be initiated at the same time at all the centre’s.

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All the Investigators should give a written acceptance of the protocol to be followed for the trial duly approved by the ethics committee of the host institutes.
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Meetings should be organized at the initial and intermediary stages of the trial to ensure uniform procedures at the all centre’s.
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Training should be imparted to research staff at the participating centre’s. to familiarize them with the uniform procedures.
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Standardization of methods for recruitment and evaluation/ monitoring of laboratory procedures and conduct of trial should be carried out.
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There should be monitoring of adherence to protocol including measures to terminate the participation of some centre’s., if necessary.
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Specific role of coordinators and monitors should be defined.
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Centralized data management and analysis should be planned.
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Drafting of a common final report and publication procedure should be decided at the outset. No individual centre should publish any data till appropriate authorities accept the combined report.
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The code of the administered drug could be broken in the event of a severe adverse reaction occurring during the conduct of a double blind trial necessitating such a step.