The monitoring process

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Stages of a monitoring visit. Before the visitDuring the visitAfter the visit. During the visit. The monitor will assess or discuss:Site, staffing, research labs or other facilitiesRegulatory file and study recordsClinical procedures if possible or appropriateAny problems and issues identif
The monitoring process

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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) Site initiation Routine(interim) visits) Close out visit

6. Pre study visit Purpose : 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 Source documentation Study product handling and accountability Safety reporting 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.

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