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
The monitoring process
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.