Objective:To explore the formulation of multi-site study strategy under drug GLP system.Methods:The investigation of sub-sites before the multi-site study,the responsibilities and ways of communication and cooperation modes of staff at all levels in the multi-site study,and several strategies for conducting multi-site study were analyzed.Results:A multi-site study was a study with a research plan and a final report,which must comply with GLP standards.Therefore,a laboratory that fully complied with GLP standards should be selected as a sub-site.Before the multi-site study,careful planning should be carried out to define the communication methods and responsibilities of relevant personnels,and as the only control point of the study,SD must play a central role in ensuring compliance.Conclusion:To formulate a multi-site study strategy that meets the requirements of GLP regulations at home and abroad under the drug GLP system,it is necessary to grasp the principle that multi-site study is a single study,select the GLP laboratory as a sub-research site,carefully plan,and staff at all levels strictly perform their responsibilities and establish smooth communication methods,so that SD can fully play the role of facilitator.
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