Drug Evaluation Committee Points to keep in mind when collecting data in post-marketing use-results surveys
Data Science Subcommittee
October 2020
With the revision of the GPSP Ministerial Ordinance in April 2008, there is a stronger need to select scientifically optimal methods and conduct efficient and effective surveys according to the purpose of each survey. The results of the discussions were summarized in this document.
We are publishing this document in the hope that sharing the ideas on data collection outlined by the task force will promote more scientific discussions on data collection. We hope that you will use this document to engage in lively discussions with your internal stakeholders when considering the items and categories of data to be collected or the level of detail of data to be sought in a new post-use surveillance.
2019KT6_Precautions for Data Collection in Post-Marketing Surveillance (755KB)
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