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1. The monitoring process
2. Stages of a monitoring visit Before the visit
During the visit
After the visit
3. During the visit The monitor will assess or discuss:
Site, staffing, research labs or other facilities
Regulatory file and study records
Clinical procedures if possible or appropriate
Any problems and issues identified
Debrief at end of visit
4. After the visit The monitor will
Complete site visit report
Submit the report to the sponsor
The sponsor will:
Distribute site visit report to the site
5. 4 types of monitoring visits: Site assessment(pre trial)
Close out visit
6. Pre study visit
It?s a face to face meeting with the investigator to explore the overall feasibility of the site and the investigator to participate into the study.
May be combined with the study initiation visit.
7. Site assessment
8. Study initiation visit Purpose:
- 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.
9. Study initiation(cont) The monitor will meet with the study staff to discuss research obligations under GCP:
Investigator administrative responsibilities
IRB approvals and communications
Regulatory file requirements(ICH GCP E6 8.2)
Informed consent forms and process
Protocol and protocol amendments
Study product handling and accountability
Protocol specific training
Archiving of study documents
10. Study initiation (cont) The monitor will Review sponsor policies , standards and procedures for the conduct of clinical trials. Reassess the site facilities Provide additional guidance to the site as determined by his/her findings. The better the site initiation, the better the site performance.