The Republic of Korea has a registry, Clinical Research Information Service (CRIS), which has the provision to report both protocol registration and result. CRIS is a World Health Organization (WHO) recognized primary registry. The clinical trial protocol and result posted on CRIS are available for public view on the Clinical Research Information Services (CRIS) website. Additionally, the Ministry of Food and Drug Safety (MFDS) has established another clinical trial disclosure platform, according to which protocol registration and results posting of all clinical trials approved by MFDS is mandatory. The MFDS registry is not a WHO recognized primary registry.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| CRIS | Additional National Registry/Database (may be mandatory) | Competent authority | Clinical Trial Application |
Interventional (Phase 0-4);Observational |
Korean 
English |
| MFDS | Mandatory National Database (includes Ethics Requirement) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 1-3) |
Korean |
| Registration and Results Requirements | |||
| Registry | Activity | Legal Requirement | Timing |
| CRIS | Registration |
No |
Prior to first subject enrollment |
| Results |
No |
Within 12 months after completion of clinical studies | |
| MFDS | Registration |
Yes |
After approval by MFDS; prior to first subject enrollment |
| Results |
Yes |
Within 1 year of global last patient last visit | |
Registry Updates
- April 2021: Republic of Korea Regulatory Update - Notice for Partial Correction of Input Items and Changes to Existing Registered Research Data Clinical Research Information Service (CRIS), the primary registry of Korea published a notice on 20 April 2021. In context of the same: Recently, WHO ICTRP announced that some of the choices in the Study Data Sharing Plan for the International Clinical Research … Continue reading "April 2021: Republic of Korea Regulatory Update"
- April 2021: Republic of Korea Regulatory Update - Notice of Temporary Suspension of the Functions of CRIS (Primary Registry of Korea) due to Homepage Renewal Work Clinical Research Information Service (CRIS) published a notice on April 20, 2021. In the context of the same: Due to the renewal of the Clinical Research Information Service (CRIS) website, functions related to clinical research registration are … Continue reading "April 2021: Republic of Korea Regulatory Update"
References
- Result posting timeline. FAQ. https://cris.nih.go.kr/cris/board/listFAQBoard.do?board_seq=8. Published April 27, 2018. Accessed May 20, 2021.
- Data elements. CRIS. explain.pdf (nih.go.kr). Published August 18, 2015. Accessed October 24, 2018.