Monitoring, clinical trial guidelines

The requirements of GCP, as described in the ICH guidelines, are presented in Chapter 7 and will not be discussed further here. However, it is emphasised that the standards required of large clinical trials in patients apply equally to small clinical pharmacological studies in healthy subjects. Studies should be conducted in accordance with SOPs. Many SOPs will resemble those pertaining to later phase clinical trials, but some will be specific to healthy volunteer studies. Details of procedures not covered by SOPs should be specified in the protocol. Studies must be monitored by the sponsor or a representative the monitor should not be one of the investigators so that monitoring visits and assessments can maintain objectivity. 

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... 

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