Drug Evaluation Committee Points to keep in mind when collecting data in post-marketing use-results surveys
October 2020
In April Heisei 30, the GPSP Ministerial Ordinance was amended, placing greater emphasis on selecting the scientifically optimal methods based on the specific objectives of each survey and conducting surveys in an efficient and effective manner.In response to the revision of the GPSP Ministerial Ordinance, the Data Science Subcommittee formed a task force to reexamine data collection for usage surveys, discussing whether the data “will be used for analysis,”“whether data is collected merely out of habit,” “whether data items capable of answering the research questions have been defined,” and “whether data can be collected given the nature of the usage survey.” The results of these discussions are summarized in this document.
We are publishing this document in the hope that widely sharing the data collection approach summarized by the task force will promote more scientific discussions on data collection. We hope you will use this document to engage in active discussions with relevant internal stakeholders when considering the data items, categories, or the level of detail required for the new post-marketing surveillance.
2019KT6_Points to Note Regarding Data Collection in Post-Marketing Surveillance (755KB)