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A Site Management Organization (SMO) is an … 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 . 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 (but not all) 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 violationsting investigators of potential violations
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| rdfs:comment |
A Site Management Organization (SMO) is an … 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 . 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 (but not all) of the responsibilities include: not all) of the responsibilities include:
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| rdfs:label |
Site management organization
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