The monitoring process . Stages of a monitoring visit. Before the visit During the visit After the visit. During the visit. The monitor will assess or discuss: Site, staffing, research labs or other facilities Regulatory file and study records
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Before the visit
During the visit
After the visit
Site assessment(pre trial)
Close out visit
May be combined with the study initiation visit.
- to uniformly provide study specific information to investigator(s) and study staff prior to study start up.
- reassess resources and capability to conduct a research study.
The better the site initiation, the better the site
Key data :
Any gross errors in these might be detrimental to the scientific and ethical quality of the clinical trial.