Site management organization

Organization that provides clinical trial-related services

A Site Management Organization (SMO) is an organization that provides clinical trial-related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company, or a clinical site. The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol. The scope of an SMO's responsibility is limited to the site and hence the eponymous title. Some of the responsibilities include:Contract Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval. In Europe, submission to Ethics Committee is often done by sponsor or by CRO, i.e. not by SMO Patient counseling Patient recruitment Patient follow-up Informed consent form (ICF) translation into vernacular languages. In Europe, this is often done by the Sponsor or CRO Site initiation and trial close-out operations Trial-related documents archival and maintenance Reporting serious adverse events to the Sponsor or CRO and the IRB/IEC Ensuring protocol compliance Advising & alerting investigators of potential protocol violations Advising & alerting investigators of potential ICH-GCP violations

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