Research services
Research Regulation and Compliance
Safeguarding the integrity, quality, and compliance of all research activities.
Overview
The Research Regulation & Compliance is a centralized service department that provides regulatory oversight, governance, and operational support across the full research lifecycle. By combining strong regulatory frameworks with innovative IT-enabled workflows, RRCD supports and strengthens institutional capacity to conduct high-quality, ethical, and impactful research aligned with national and international requirements. The RRCD develops institutional policies, guidance and SOP’s in alignment with national and international standards for the conduct of research.
Regulations, Ethics, and Compliance
We partner with investigators, departments, and committees to reduce regulatory risk, improve review efficiency, and promote responsible research conduct.
RRCD ensures that research activities for the institution comply with the laws and regulations of the Kingdom of Saudi Arabia, ethical principles, and institutional policies as well as with international regulatory bodies and guidance and for the conduct of research and protection of Human Participants such as:
National Committee for Bio Ethics (NCBE).
Saudi Food and Drug Authority (SFDA).
Saudi National Institute of Health (Saudi NIH).
International Council for Harmonization, good Clinical Practice (ICH-GCP).
US Food and Drug Authority (FDA).
Office for Human Research Protections (OHRP).
Research Regulation and Compliance ensures that the conduct of research activities is in alignment with the Saudi Personal Data Protection Law (PDPL).
What We Do
Research Regulation and Compliance provides administrative and regulatory support for the Research Ethics Committee & its associated sub-committees and boards including the:
Institutional Review Board (KFSHRC-IRB).
Data Safety Monitoring Board (DSMB).
Clinical Research Committee (CRC) and its Clinical Research Review Board (CRRB).
Basic Research Committee (BRC).
Animal Care and Use Committee (ACUC).
Support and Guidance for Researchers
Research Regulation and Compliance assists researchers by maintaining and disseminating regulatory updates, providing consultation services for requirement interpretation and study-start readiness guidance and providing education and mandatory training for research compliance such as Good Clinical Practice (GCP) certification support.
Bio Specimen Handling and Storage
Research Regulation and Compliance provides oversight and guidance for storage, shipping, use, and documentation policies and procedures to ensure compliant handling and use of bio specimens and genetic materials in alignment with the national and international laws and regulations.
Beta Version