For instance, although some committees were satisfied with monthly summary reports, some committees requested an expedited reporting of all SAEs, whether related or not related to the study vaccine, in addition to the monthly summary reports.
This study was approved by our institution's IRB as an expedited study with an HIPAA waiver.
Real-time safety monitoring occurred on an ongoing basis for all patients and expedited reporting was performed for serious AEs and AEs of special interest.
Annual Safety reports: In addition to the expedited reporting above, the PI shall submit an annual safety report throughout the clinical trial, and any additional reports on request.
In addition to the expedited reporting above, the Chief Investigator shall submit, once a year throughout the clinical trial, or on request, a safety report to the Ethics Committee.
All potential SUSAR's are subject to expedited reporting.
All potential SUSARs are subject to expedited reporting.
In addition to the expedited reporting of SAE's, the principal investigator will submit, once a year throughout the clinical trial, a safety report to the accredited METC.
All serious adverse events (SAEs) that are thought to be related to treatment are subject to expedited reporting and will be reported within 24 h.
The expedited reporting will occur not later than 7 days after the responsible investigator has first knowledge of the adverse reaction.
World Health Organization Upsalla Monitoring Centre: The Global Intelligence Network for Benefits and Risk in Medicinal Products http://www.who-umc.org/ Accessed on: Feb 8, 2010 World Health Organization: Note for guidance on clinical safety data management: definitions and standards for expedited reporting.
