Hong Kong runs its own system: a clinical trial certificate under the Pharmacy and Poisons Regulations, ethics review at hospitals and universities, and a separate data law from mainland China. Capture gives Hong Kong teams a self-serve EDC they can build and test free.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study region
Hong Kong SAR
Key points for studies in Hong Kong
Regulation
Hong Kong does not have a standalone clinical trial statute. The route runs through the Pharmacy and Poisons Regulations: regulation 36B requires a certificate for a clinical trial or medicinal test on human beings, and the Department of Health guidance notes say the Committee under the Pharmacy and Poisons Board issues it. The Drug Office handles applications and correspondence. Separate guidance covers advanced therapy products, so check the right document for your product type.
The application is built around the protocol, the investigator brochure or product information, consent documents, site and investigator details and evidence of ethics review or its planned timing. Capture produces a blank eCRF PDF with a cover page, form index, visit-by-form matrix and every approved form printed empty, which sits comfortably in that package and in the ethics submission.
Hospital rules matter in practice. The codes of practice for private hospitals expect a clinical drug trial to be covered by a valid certificate, and public hospital clusters require their own committee approval. The exact committee for your site depends on the institution, so ask the research office which committee reviews the study and whether a joint or reciprocal arrangement applies across clusters or universities. See how to get IRB approval for the general package ethics committees want.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
Approvals
| Layer | Body | What you need | Where Capture helps |
|---|---|---|---|
| Trial certificate | Committee under the Pharmacy and Poisons Board; Drug Office, Department of Health | Protocol, product information, investigator and site details, consent | Blank eCRF PDF to show what is collected. |
| Ethics | Hospital cluster or university research ethics committee | Protocol, consent forms, participant information, CVs | Consent template and signed consent PDF. |
| Institution | Hospital research office, contracts and insurance | Clinical trial agreement, indemnity, site capacity | Site-level accounts, roles and delegation. |
| Data protection | PCPD guidance under the PDPO | Purpose, collection notice, security and transfer arrangements | Coded IDs, row-level security, encryption. |
| Registry | Public registry, per sponsor policy or journal rules | Trial registration number | Registry fields reused from the protocol. |
Check each layer with the Drug Office and the site research office. Timelines vary and are not stated here.
Data protection
The PDPO works through six data protection principles: purpose and manner of collection, accuracy and retention, use, security, openness, and access and correction. Medical data is personal data, and the principles apply whether the data stays in Hong Kong or not. Section 33, which would restrict transfers outside Hong Kong, was enacted with the ordinance but has never been brought into force, and there is no official timetable. In 2022 the PCPD published Recommended Model Contractual Clauses for transfers between data users and from data users to processors, and recommends them as good governance, not as a legal requirement.
In a trial this means the collection notice and consent should tell participants who receives their data and where. Capture is hosted in Frankfurt and N. Virginia, so Hong Kong data is processed abroad. Write that into the participant information and the agreement between sponsor, institution and any vendor. Consider adopting the PCPD clauses in your contracts, and ask Hong Kong counsel whether your institution has its own research data policy that goes further.
Capture keeps identity apart from analysis: site coordinators see participant names while researchers see coded IDs, enforced by row-level security. Data is encrypted with AES-256 at rest and TLS in transit. Compare approaches in GDPR compliant clinical trial software.
Site coordinator
Jane Peterson
DOB: 04-Mar-1978
Subject 01-004
Sees direct identifiersResearcher
Subject 01-004
DOB: withheld
Coded ID only
Sees coded ID onlySame record, two roles. Row-level security enforces the split.
Build the forms, generate the blank eCRF PDF and sign a test consent in the free sandbox.
Hong Kong research
Hong Kong has two medical schools, major public hospital clusters run by the Hospital Authority, and a private hospital sector. Investigator-initiated studies, early-phase work and academic registries sit next to multinational trials. Many teams are small and want a system they can set up themselves without a long procurement. Capture has no setup fee and no per-site fee, which suits EDC for academic clinical trials and EDC for investigator-initiated trials.
Because Hong Kong sits next to mainland China, some studies recruit on both sides of the boundary. That is where jurisdictions interact: data from mainland participants can be subject to the mainland rules described on the China page, and Hong Kong sites alone fall under the Hong Kong regime. Keep sites and their data flows clearly separated in the study design, using site-level participant numbering and by-site exports so each part can be reported on its own terms.
Safety and queries
Edit checks raise an automatic query when a site enters a value that breaks a rule, and serious adverse events are routed to the safety contact for follow-up. Reporting timelines to the Department of Health and to ethics committees depend on your protocol and the committee, so set them out in your safety plan and check them with the Drug Office.
SAE timeline
SAE reported
Day 0 · 09:12
Safety alert acknowledged
Medical monitor · 09:40
Site staff attestation
Study coordinator · 11:05
AE sign-off (PI / Sub-I)
Awaiting signature
Typical start-up
A sketch for planning, not a regulatory timeline.
Ask the site research office which committee reviews your study and whether a joint review is available.
Protocol, product information, consent and participant information, the blank eCRF PDF and investigator details.
Submit to the Drug Office for the Committee under the Pharmacy and Poisons Board using its current guidance notes.
Clinical trial agreement, indemnity and a data protection clause covering hosting in the EU or US.
Create site accounts, train staff, then enrol after the certificate and committee approval are in the file.
Before you start
Application route confirmed with the Drug Office, including any product-specific guidance.
The committee of each site identified, with any joint review agreed.
Collection notice, consent wording and transfer arrangements for EU or US hosting, checked with counsel.
Decision on whether any mainland sites, samples or data are involved.
English and Chinese versions approved by the committee, prepared by your team.
Coordinator and investigator accounts matched to the delegation log.
The Pharmacy and Poisons Board, through a Committee that issues the Certificate for Clinical Trial / Medicinal Test, with the Drug Office of the Department of Health as executive arm. Ethics committees review separately. Confirm the current process with the Drug Office.
No. The certificate is a regulatory authorisation. Hospitals and universities also require review by their research ethics committee.
The Personal Data (Privacy) Ordinance, supervised by the Privacy Commissioner for Personal Data. Section 33 on cross-border transfers is not yet in force, but the PCPD recommends model contractual clauses. Ask Hong Kong counsel what applies to your study.
No. Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). Say so in participant information and contracts.
Not to Hong Kong sites alone. If mainland sites, samples or data are involved, mainland rules may apply to that part. See the China page and ask counsel.
No. Capture is a self-serve platform. Your team or the CRO you appoint builds and runs the study in it.
No regulator approves EDC software. Capture provides controls such as an audit trail and e-signatures, and your validated use is what is assessed.
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring
Clinical trial software in China
NMPA, HGR and data export.
Clinical trial software in Taiwan
TFDA and joint IRBs.
Clinical trial software in Singapore
HSA and ethics boards.
EDC for academic clinical trials
University studies without a big budget.
How to get IRB approval
What committees ask for.
eConsent software
Verified electronic signatures.
Self-serve EDC, eCRF and eConsent. Free sandbox, no credit card.