Checklist for multicentre trials
This checklist has been modified from a checklist prepared for the International
Conference on Harmonization Guideline for Good Clinical Practice (ICH GCP)
For multicentre trials, the trialist should ensure that:
- All investigators conduct the trial in strict compliance with the protocol
agreed to by the sponsor and, if required, by the regulatory authority(ies).
- The data collection forms are designed to capture the required data
at all multicentre trial sites. For those investigators who are collecting
additional data, supplemental data collection forms should also be provided
that are designed to capture the additional data.
- The responsibilities of coordinating investigator(s) and the other
participating investigators are documented prior to the start of the trial.
- All investigators are given instructions on following the protocol,
on complying with a uniform set of standards for the assessment of clinical
and laboratory findings, and on completing the data collection forms.
- Communication between investigators is facilitated.
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trials
This document was last updated on 30th June 2003.