Republic of Korea

Republic of Korea

Clinical Research Information Service (CRIS)

Verified on September 8, 2021

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 result posted on CRIS may be available as PDF file for public view on Clinical Research Information Services (CRIS). 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


References


  1. Result posting timeline. FAQ. https://cris.nih.go.kr/cris/board/listFAQBoard.do?board_seq=8. Published April 27, 2018. Accessed May 20, 2021.
  2. Data elements. CRIS. explain.pdf (nih.go.kr). Published August 18, 2015. Accessed October 24, 2018.