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Site management organizations (SMO)
These are hired to co-ordinate with CRO to ensure rapid IRB/IEC approval and faster site initiation and patient recruitment. The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements. SMOs are relatively new entrants into the field of clinical research and have since grown at an explosive rate in the U.S. and other countries like India, China and Brazil where clinical trial outsourcing has been at its peak.
Responsibilities of site are
- Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval
- Patient Counseling
- Patient Recruitment
- Patient Follow-up
- Informed consent form (ICF) translation into vernacular languages
- Site initiation and trial close-out operations
- Trial-related documents archival and maintenance
- Reporting serious adverse events to the 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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