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Course Description
Monitoring is a sponsor’s regulatory obligation therefore the monitoring report and follow up visit letter are the regulatory documents to demonstrate the sponsor’s compliance with this obligation. These reports may be audited by the FDA and should be written to cover all monitoring activities in the monitoring plan, in a neutral tone, and document any GCP non-compliance using the concept of (CAPA) Corrective Action and Preventative Action Plan. The documentation using CAPA demonstrates the securing of compliance of that investigator. The participant of this program will be asked to write mock reports covering several GCP non-compliance using CAPA plans as a resolution. In addition, we will learn how to write Memo-to-Files that are left at the site to explain an issue or provide clarification.
Daily Agenda / Course Topics
| 1 |
Monitoring Regulatory Obligation and Guidance |
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21 CFR 312 and 21 CFR 812 |
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FDA Guidelines Drug/Biologic |
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ICH GCP Section 5: Sponsor |
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Monitoring Reports are a Regulatory Document
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ICH GCP (E 6) Section 5 (5.18.6a) |
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FDA access to reports |
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FDA monitoring warning letters |
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| 2 |
Monitoring Report Content |
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ICH GCP (E 6) Section 5, 5.18.6b-c |
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Types of Issues documented in a Monitoring Report
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GCP versus Non-GCP |
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GCP issues should have compliance secured by using Corrective Action and Preventative Action Plans (CAPA) |
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Issue/Action/Resolution format in reports |
| 3 |
Monitoring Report Content |
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Check lists vs. narrative comments |
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Third person vs. first person tense |
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Neutral wording, facts and findings only |
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Documentation considerations on Key GCP areas
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Source Documentation, Informed Consent, IRBs, SAEs, Protocol Violations |
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Documentation considerations for sites that are transferred to a CRA |
| 4 |
Report Writing Drill |
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Review examples of good vs. bad monitoring reports and a follow up visit letter |
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Write a report using the concept of CAPA for GCP related issues |
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Writing Memo to Files relating to CAPA issues |
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