China has a clinical trials registry, the Chinese Clinical Trial Registry (ChiCTR). It is a World Health Organization (WHO) recognized primary registry. It has a provision for both protocol registration and results posting. Additionally, as per the administrative measures for drug registration, protocol registration and results posting on Drug Clinical Trial Registration and Information Disclosure Platform (ChinaDrugTrials.org.cn) is a mandatory requirement, which is managed by the Drug Evaluation Center of China.
Registries at a Glance | |||||
Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
ChiCTR | Mandatory National Database (includes Ethics Requirement) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 1-4);Observational |
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CCRB | Mandatory National Database (includes Ethics Requirement) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 1-4);Observational |
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Drug Clinical Trial Registration and Information Disclosure Platform (ChinaDrugTrials.org.cn) | Mandatory National Database (includes Ethics Requirement) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 1-4) |
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ITMCTR | Additional National Registry/Database (may be mandatory) | Sponsor | Through a dedicated registration platform (process independent from clinical trial application) |
Interventional (Phase 1-4);Observational |
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Registration and Results Requirements | |||
Registry | Activity | Legal Requirement | Timing |
ChiCTR | Registration |
No |
Prior to enrollment |
Results |
No |
Within one year of trial completion | |
CCRB | Registration |
No |
Prior to enrollment |
Results |
No |
NA | |
Drug Clinical Trial Registration and Information Disclosure Platform (ChinaDrugTrials.org.cn) | Registration |
Yes |
Prior to enrollment |
Results |
Yes |
Within one year of trial completion | |
ITMCTR | Registration |
No |
Prior to enrollment |
Results |
No |
NA |
Registry Updates
- March 2023: China/WHO Registry Update - On 3 March 2023, the International Traditional Medicine Clinical Trial Registry (ITMCTR) was added to the Primary Registries Network of the International Clinical Trials Registry Platform (ICTRP) by the World Health Organization (WHO). It is the first cross-regional clinical trial registry that targets traditional medicine, in the WHO ICTRP registry network. The ITMCTR is a … Continue reading "March 2023: China/WHO Registry Update"
- July 2022: China Registry Update - Suspension of Supplementary Registration From July 05, 2022, the Chinese Clinical Trial Registry (ChiCTR) has suspended supplementary registration of Clinical Trials. Supplementary registration is defined as the registration done after the first case of candidate is recruited. There have been no other changes made to the information available for supplementary registrations on the ChiCTR website.
- September 2021: China Update - After the upgrade to Center for Drug Evaluation’s website on September 13, 2021, the “Applicant’s Window” login for the platform (also known as Drug Clinical Trial Registration and Information Disclosure Platform) is now available along with the old system account login. As mentioned in the “Instructions for Drug Clinical Trial Registration and Information Disclosure Platform … Continue reading "September 2021: China Update"
References
- Login for ChiCTR. http://www.chictr.org.cn/enIndex.aspx. Published October 2005. Accessed November 13, 2018.
- WHO Data Set. World Health Organization. https://www.who.int/clinical-trials-registry-platform/network/who-data-set. Published May 2007. Accessed November 13, 2018.
- Which trial should be registered. ChiCTR. http://www.chictr.org.cn/questionen.aspx. Published October 2005. Accessed November 13, 2018.
- Results for public. ChiCTR. http://www.chictr.org.cn/uploads/documents/384799098e204749a21fa533028955f1.pdf. Published October 2005. Accessed November 13, 2018.