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Human subject protection is a pillar of clinical research. Research ethics oversight and safety review by research ethics committees (RECs) plays an important part, and its effectiveness relies on the smooth and close communication between study sites and RECs.
In HKU/QMH, subject protection is the top priority in any clinical study. HKU-CTC has a team of specialists in research ethics who offer full support to investigators and study sites on research ethics affairs and safety reporting in any stage of any clinical study.
In order to enhance the efficiency, effectiveness and traceability of reporting and reviewing of suspected, unexpected serious adverse reactions (SUSARs) from external study sites in multicentre clinical studies, HKU-CTC has developed a proprietary electronic platform namely PEARS (Platform for Electronic Adverse Reports Submission). Through PEARS, sponsors/CROs can submit SUSAR reports to investigators online and receive instantaneous acknowledgements of receipt over the system. Investigators on the other hand can easily review and endorse SUSAR reports anytime, anywhere through the internet. The flow of each SUSAR report is centrally tracked and is available for online checking by investigators and sponsor/CROs. Submission of SUSAR reports for multiple protocols is also allowed.
|Professional consultation on research ethics affairs|
|Compilation of initial ethics review applications|
|Submission of progress reports and final reports|
|Submission of amendments and new information|
|Reporting of deviations and compliance incidents|
|Submission of local site SAE reports|
|Receiving and submission of external site SUSAR reports|