South Korea's large academic hospitals, especially in Seoul, are among the most active trial sites in the world and often enrol quickly. Capture keeps those sites on the same forms, checks and audit trail as the rest of your study.
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Study region
South Korea
Key points for studies in South Korea
Research landscape
South Korea has built one of the densest clinical research infrastructures in Asia, concentrated in large academic medical centres with dedicated trial units and experienced coordinators. Global sponsors value those sites for enrolment speed; the flip side is that a fast site generates a lot of data quickly, and any design flaw in the forms is multiplied.
Edit checks that raise queries at entry, SDV focused on critical fields and a status overview of every subject and visit let data managers keep up with a fast site without waiting for the next monitoring visit. See edit checks and risk-based monitoring.
PIPA treats health information as sensitive and sets specific conditions for transferring personal information abroad, traditionally centred on the data subject's consent, with additional legal bases introduced by recent amendments. Plan the transfer basis with your Korean sites and legal advisers, reflect it in the consent form, and keep identifying information at the site: in Capture, sponsor-side users see coded participant IDs only.
Randomized
142 / 180
Open queries
19
Fields verified
88%
Data quality at speed
Range and custom-value edit checks raise auto-queries the moment a value breaks a rule, and a corrected value can close its own query. The site risk monitor rates each site and says why, so a query backlog at a busy site is visible early.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
Add sites in several countries and see them side by side.
Before you start
For medicinal product trials, under Korean GCP.
Each participating hospital's IRB.
Agreed, documented and reflected in consent.
Approved consent and participant materials; official translations of instruments.
Ethics approval, contract, initiation visit and delegation log.
Centralised review sized for fast-enrolling sites.
Planning
| Decision | Why it matters with fast sites | How to handle it |
|---|---|---|
| Per-site enrolment cap | One site can dominate the dataset and site effects become hard to separate. | Set a cap in the protocol and review enrolment by site weekly. |
| Country or region cap | Regulators in other regions may ask whether results apply to their populations. | Agree regional targets in the development plan. |
| Stratification by site or region | Balances arms within fast-enrolling sites. | Configure stratification factors at setup. |
| Monitoring intensity | A large site generates a lot of data between visits. | Centralised review of queries and risk indicators, with targeted on-site visits. |
| Screening log review | High screening volumes need consistent eligibility decisions. | Eligibility forms with edit checks on inclusion and exclusion criteria. |
Working with Korean sites
Large Korean hospitals often have dedicated clinical trial centres with specialised coordinators, pharmacy teams and monitoring rooms, and many have worked with global sponsors for years. They are used to electronic data capture and expect clear CRF completion guidelines, prompt answers to queries and a system that does not slow them down.
In practice that means forms that follow the visit flow, edit checks that fire at entry rather than weeks later, and a coordinator view that shows exactly what is due. For stratified trials, the allocation should appear the moment a participant is randomised, logged in the audit trail, so the site can dispense without waiting. See clinical trial randomization software.
The Ministry of Food and Drug Safety (MFDS) approves clinical trials of medicinal products, under Korean GCP.
The Personal Information Protection Act, South Korea's data protection law, which treats health data as sensitive and regulates transfers abroad.
Yes. Every site runs in the same study with the same forms, checks and audit trail.
Capture hosts study data in the EU (Frankfurt) or the US (N. Virginia), chosen at study setup, with AES-256 encryption at rest and TLS in transit. Assess the cross-border transfer rules that apply to your study before choosing.
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring
Queries at entry, one study across countries. Free sandbox.