Regulatory support
The regulatory support team is here to help investigators navigate the regulatory process of research involving drugs and medical devices. Whether planning a new study or managing an ongoing one, we provide investigators with support and guidance to ensure compliance with regulatory requirements, including those set by the FDA, HHS, and IRB. Our goal is to make the regulatory process as clear and efficient as possible for our investigators.
Routine study audits
As part of Boston Children's on-going effort to ensure the protection of human subject in clinical research, the Regulatory Affairs and Education Program conducts investigator routine study audits that aims to:
- Ensure on-going compliance with IRB approved protocol, institutional policies, sponsor’s SOP, Good Clinical Practice (GCPs) and applicable regulations
- Ensure the scientific integrity and data reliability of study data
- To help investigators and research teams conduct compliant research
- To learn how Boston Children's as in institution can support the research community to facilitate compliance
Routine study audits (or not-for-cause) are randomly selected from all Boston Children's studies involving human subjects active at the time. Principal Investigators (PIs) and research teams can also request a routine study audit.
Education and resources