Drug Evaluation Committee Points to keep in mind when collecting data in post-marketing use-results surveys
Data Science Subcommittee
October 2020
In accordance with the revision of the GPSP Ordinance in April 2008, the Data Science Subcommittee has formed a task force team and reiterated the following points regarding data collection in post-marketing use-results surveys. 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)