In order to understand if there is other unknown side effect during the clinical trail, the PMS (Post-Marketing Study) will be conducted to learn more treatment experiences on patients, and collect their information for further study.
No. 9 of IRPMA COP Benchmarks regulates that all PMS shall go through JIRB, IRB or Ethics Committee and must be registered on the website of IRPMA PMS registry system. It is to ensure the studies conducted on patients have been approved by JIRB, IRB and protect patient’s right of privacy. The public can also get the information and objective of the PMS through the registry system. |
