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Course Description
The starting point in creating a quality monitoring process is using a systematic approach. This course trains the CRA on MRM's three step monitoring method to facilitate consistency and standardization in performing the monitoring responsibilities. Another important aspect of monitoring is learning how to bring a non-compliant investigator into compliance using Corrective Action and Preventative Action (CAPA) plans and documenting such plans in a professional and effective monitoring report and follow-up visit correspondence. This 3 day course is enhanced by the hands-on training that utilizes simulated case studies, an investigator study file, and report writing exercises. These techniques can be applied to all studies whether they are drug, device, or biologic.
Daily Agenda / Course Topics
| 1 |
Overview of Monitoring and Preparation for the Case Studies |
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Monitoring Obligation and Purpose |
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Monitoring Activities |
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General Monitoring Plan Content |
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Three-Step Monitoring Method/Technique, Tools, and Organization |
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Developing Corrective and Preventative Action Plans (CAPA) for GCP ICH non-compliance |
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Monitor preparation prior to a site visit |
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Setting up the Monitoring file system |
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Protocol and CRF Review for Case Study Exercises on Day 2 and Day 3 |
| 2 |
Case Study #1 |
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Applying Monitoring Technique and Tools |
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Monitor SV1, SV2, V1, AEs, and CC meds |
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Case Study # 1 – Review and Discussion of Deficiencies, Remedies, and Prevention (CAPA) |
| 3 |
Case Study #2 |
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Applying Monitoring Technique and Tools |
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Monitor SV1, SV2, V1, AEs, and CC meds |
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Case Study #2 – Review and Discussion of Deficiencies, Remedies, and Prevention (CAPA) |
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Potential Issue/Problem Exercise |
| 4 |
Investigator Study File Review including the Regulatory reason and different SOP requirements |
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ISF Case Study – Monitoring |
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ISF Case Study – Review and Discussion of Deficiencies, Remedies, and Prevention |
| 5 |
Monitor Report and Follow-up Letter |
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Content “What goes in a report” and Writing Style |
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Writing Reports using the CAPA style (Corrective Action and Preventative Action) to document the securing of compliance |
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