Professional Documents
Culture Documents
Greetings!
Seek approval from WU-P UREC for any protocol/document amendment after this date
Submit reports in case there are Serious Adverse Events (SAE) and Suspected Unexpected
Serious Adverse Reaction (SUSAR) to UREC within seven days
Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction
(SUSAR) defines as any untoward medical occurrence that:
- results in death
- life-threatening
- requires hospitalization or prolongation of existing hospitalization
- results in persistent or significant disability or incapacity, or
- results in a congenital anomaly or disability.
The UREC reviews such reports to determine appropriate action to protect the safety of
participants in the approved study
Report any deviation/violation to the approved protocol
Abide to the principles of good clinical practice and ethical research
Comply with all relevant international and national guidelines and regulations
Submit final report after completion of study
Others: Elaborate the procedure in measuring the effects of stigma
The WU- P UREC has the authority to suspend or terminate the approval of this research
when the safety of participants is no longer assured. When UERC takes such action, it is
required to provide the reasons for its operation and to promptly report a decision to the
investigator, the sponsor, the institution, and relevant regulatory authorities.
Respectfully yours,
Noted: