Sponsor monitoring

The evaluation of all NADA analytical methods was previously conducted exclusively by the CVM. Since 1995, the CVM has offered sponsors of NADA residue methods the option of conducting the method trial through a Sponsor Monitored Method Trial (SMMT) process. The SMMT is conducted according to CVM specifications with CVM oversight. The resultant performance data must be reviewed and judged acceptable by CVM before the method is approved. 

Sponsor Monitoring. Another important oversight process to ensure quality, compliance, and subject safety, monitors may be employees of the sponsor s medical staff or a contract research organization, or may be independent contractors. In each... 

Provision for monitoring and audit of study site and ongoing cooperation and liaison between sponsor, monitor and CRO/ investigator must be made. 

Regarding sponsor/monitor regulations, Brit. Med., (1978, in press). 

July Sponsor/monitor operations Nine unreported recalls/market... 

Management of safety is a principal responsibility of the sponsor monitor. The monitor has responsibility for informing the investigator about the safety requirements of the study. This will include a discussion of expected and unexpected adverse events, how to report adverse events should they occur and how to characterize the adverse events in terms of project-specific definitions. 

The sponsor monitor is responsible for the timely follow-up of all SAEs. The cases must be followed to completion. The monitor needs to... 

Furthermore, it is strongly recommended that investigators, sponsors, monitors, and all others involved in clinical trials adhere to international standards for the proper management of clinical trials (i.e., GCP released by the International Conference on Harmonisation, involving the European Medicines Evaluation Agency [EMEA], and the agency s counterparts in other countries [United States and Japan]). 

Both the CFR and the ICH GCP guidelines require that the sponsor monitor the progress of the clinical trial at the site where the trial is being conducted. How frequently these... 

Name of the person or class of persons that will receive the disclosed information, e.g., sponsor, monitors, CROs, statisticians. 

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