PEARS (Platform for Electronic Adverse Reports Submission) is an internet based, built-in with technical controls and U.S. Code of Federal Regulations Title 21 Part 11 (“21 CFR 11”) compliant proprietary electronic platform developed for reporting and reviewing of safety reports of clinical studies by multiple users.

PEARS is a validated system, which allows sponsors and/or contract research organizations (“ CROs”), to submit safety reports to investigators and HKU-CTC electronically for IRB reporting, and receive instantaneous acknowledgements of receipt over the system. Through PEARS, investigators can easily review and endorse submission of safety reports anytime, anywhere upon receipt of automatic notification. The preparation and submission process of each safety report via PEARS are centrally tracked and users can monitor the progress of their submission on a real-time basis. Single submission of safety reports for multiple protocols is also allowed.

For enquiries about PEARS, you may contact our PEARS Administrator via: email at pears@hku.hk or phone at (852) 3910 3043 / 3910 3046.