About QA Activities
QA Activities
The Quality Assurance (QA) Office of the HRPP conducts independent, systematic internal audits to ensure that research carried out at Seoul National University Hospital is performed in accordance with the relevant regulations and the approved protocol, and is responsible for preparing for and responding to inspections by domestic and international regulatory agencies.
Key Activities
Routine Audit
Audits conducted regularly according to a systematic, pre-planned method, reviewing all documents, facilities, and procedures related to the study. Targets include studies selected by the QA Office and studies for which the principal investigator voluntarily requests an audit.
For-Cause Audit
Audits conducted at the decision of the IRB, the HRPP Executive Committee, or the Director of the Center for Human Research Protection. They may be initiated upon receipt of information that could raise concerns about the safety and rights of research participants or the integrity of research data, and may be performed without prior notice to the principal investigator.
Support for Regulatory Inspections
Provides overall support during clinical trial inspections by domestic and international regulatory agencies (e.g., MFDS, US-FDA, EMA, PMDA).
Researcher Support Activities
Provides clinical trial essential-document indices, various forms, and a researcher self-assessment checklist. These documents are available in the resources section.