Japan is one of the largest pharmaceutical markets and has specific expectations for trials that support Japanese approval. Capture keeps Japanese sites in the same global study with the controls PMDA inspectors look for.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Japan
Key points for studies in Japan
Research landscape
For many years, Japanese approvals often relied on separate local trials. Joining multi-regional clinical trials from the start has become common, supported by ICH guidance on multi-regional trials and regulatory consultation with PMDA. That makes it more important that Japanese sites run in the same data system, with the same definitions and controls, as sites elsewhere.
PMDA conducts GCP inspections that look closely at records, including electronic data. A field-level audit trail with readable descriptions, filters by participant and date, and export on demand helps sites and sponsors answer inspection questions quickly. See the FDA inspection checklist for the kinds of evidence regulators ask for.
The APPI requires a basis for providing personal data to third parties in foreign countries, such as consent informed about the destination, or equivalent protection measures. Keep identifying information at the site, show sponsor-side users coded IDs, and document the hosting region in the consent and study agreements.
Weight changed 68.0 to 68.5 kg
Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
Consistency
Approved forms are locked and identical at every site, edit checks behave the same way everywhere, and randomisation is configured once for the whole study. When the protocol is amended, all sites move to the new version together.
Baseline severity: moderate
Block 7 of 12
Baseline severity: severe
Block 4 of 12
Baseline severity: moderate
Block 6 of 12
Subject 01-0048 randomized
BlindedRandomization no.
R-0166
Treatment arm
●●●●●●
Emergency unblinding
Built in for blinded designs, when participant safety requires it.
Set up randomisation with a region factor in the free sandbox.
Before you start
J-GCP trial notification, or Clinical Trials Act for other research.
Especially for multi-regional development plans.
Documented and reflected in consent.
Approved consent, participant texts and official instrument translations.
jRCT or other registries as required.
Ethics approval, contract, initiation visit and delegation log.
Terms
| Term | Meaning | Why it matters for data |
|---|---|---|
| Chiken | A clinical trial conducted to support drug or device approval. | Runs under J-GCP with PMDA oversight and inspection. |
| J-GCP | Japan's GCP ordinance, based on ICH GCP. | Sets the record-keeping and monitoring expectations. |
| SMO | Site management organisation that supports hospitals with trial staff. | SMO coordinators often do data entry, so roles and delegation must be clear. |
| CRC | Clinical research coordinator at the site, often provided by an SMO. | The main system user at most Japanese sites. |
| jRCT | Japan Registry of Clinical Trials. | Registration for studies under the Clinical Trials Act. |
| GCP inspection | PMDA review of trial conduct and records. | Audit trail and source records must be retrievable. |
Working with Japanese sites
Japanese sites are known for careful documentation and low error rates, and they expect the same precision from the system: clear field definitions, CRF completion guidelines translated into Japanese, and queries that explain exactly what is needed. Because many coordinators come from site management organisations, delegation and access need to be set up precisely, and changes in coordinator must be reflected in the delegation log and system roles at the same time.
For participant-reported outcomes, use official Japanese translations of validated instruments and keep the recall period and wording identical to the source. Browser-based questionnaires on participants' own phones work well in Japan, where smartphone use is high across age groups. See ePRO software.
The PMDA and MHLW oversee trials supporting drug approval, which follow J-GCP. Other clinical research may fall under the Clinical Trials Act.
Japan's Act on the Protection of Personal Information, which regulates personal data, including transfers to third parties 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
Same forms, checks and audit trail everywhere. Free sandbox.