RESPONSIBILITIES OF MONITOR
Monitors are appointed by the sponsor and have scientific and clinical knowledge. Sponsor determines the nature and extent of monitoring based on the objectives, design, complexity and size. Usually, the monitoring is done before, during and after the clinical trial, except, in some critical cases where central monitoring is done along with training and meetings. Statistically controlled sampling may be used to verify data. The responsibilities of the monitor involve:
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Ensuring the trial is conducted and documented properly.
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Verification of the investigator qualifications and resources.
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Verification of the investigational products regarding storage conditions and handling etc.
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Verification of the receipt, use and the return of investigational product at the trial site.
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Verifying the control and documentation of disposition of investigational product.
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To keep a check on the activities of the investigator.
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The monitor should follow SOPs and produce reports in accordance to the GCP.
