Site Management Organization(SMO) is an organization that provides clinical trial-related services to contract research organizations (CROs), pharmaceutical companies, biotechnology companies, medical device companies, or clinical trial sites. Trial sites are typically hospitals or similar healthcare facilities that have the necessary infrastructure and personnel to meet the requirements of the clinical trial protocol.

Site Management Organization(SMO)

The scope of responsibilities of an SMO is limited to the trial site, hence the name "Site Management Organization." Some (but not all) of the responsibilities of an SMO include:

• Signing contracts
• Submitting applications to the Institutional Review Board or Independent Ethics Committee (IRB/IEC) to obtain approval. In Europe, the application is typically submitted to the ethics committee by the sponsor or CRO, not the SMO.
• Providing consultation to study subjects
• Subject recruitment
• Subject follow-up
• Translating the Informed Consent Form (ICF) into the local language. In Europe, this is typically done by the sponsor or CRO.
• Site initiation and close-out activities
• Archiving and maintaining trial-related documentation
• Reporting serious adverse events to the sponsor or CRO and IRB/IEC
• Ensuring compliance with the trial protocol
• Informing and reminding investigators of potential protocol deviations
• Informing and reminding investigators of potential ICH-GCP non-compliance
• Assisting in the handling of subject compensation (if needed)
• Monitoring data quality and performing source data verification on the original data
• Coordinating with hospital staff for the management and distribution of investigational drugs, medical devices, etc.

In carrying out these responsibilities, the SMO should strictly adhere to the latest regulatory requirements, guidelines, and standard operating procedures to ensure the quality of the clinical trial and the protection of the rights and well-being of study subjects.