For Clinical Studies Conducted at HKU/HA HKW Cluster
Clinical studies approved and overseen by the HKU/HA HKW IRB will be managed for registration with HKUCTR by the HKU-CTC. Permission will be solicited from Principal Investigators/Sponsors by HKU-CTC prior to public registration of clinical studies. Study Identifier will be provided to Principal Investigator for reference once the study is successfully published online.
For Clinical Studies Conducted Outside HKU/HA HKW Cluster
Applicants who are interested to register their study with HKUCTR should complete and return the registration form: “HKU Clinical Trials Registry Online Study Registration Form”, together with the approval issued by the corresponding research ethics committee to our HKUCTR Administrator of HKU-CTC for further processing. Study Identifier will be provided to Principal Investigator for reference once the study is successfully published online.
In line with the recommendation by the WHO ICTRP on study result disclosure, investigators can disclose their clinical study results on HKUCTR (through submission of the “HKU Clinical Trials Registry Study Data Public Disclosure Form” to our HKUCTR Administrator) after study completion.
In summary, clinical study results are recommended to be reported to HKUCTR according to the timeframes outlined below:
|Clinical Study Results||Results Publication Platform||Timeframe|
Main findings of clinical studies
|Peer-reviewed journal||Within 12 months of study completion; or|
|Available publicly||At most within 24 months of study completion|
|Key outcomes*||Results section of the primary clinical trial registry or on a free-to-access, publicly available and searchable institutional website where the registry does not constitute a result database for key outcomes posting||Within 12 months of study completion|
*For more details, please refer to WHO Statement on Public Disclosure of Clinical Trial Results or U.S. clinicaltrials.gov (http://clinicaltrials.gov/ct2/about-site/results).