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PGDCR in Clinical Research
Master of Science Program in Clinical Research Design and Statistical Analysis
Coordinating a Clinical Trial
Drug/Biologic Approval Process, Good Clinical Practices and an Overview of Monitoring/FDA BIMO Inspections
Advanced Quality Monitoring
Writing Professional and Effective Monitoring Report, Post Visit Letters, and Memo-to-Files
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
21 CFR 312 and 21 CFR 812
FDA Guidelines Drug/Biologic
ICH GCP Section 5: Sponsor
Monitoring Reports are a Regulatory Document
ICH GCP (E 6) Section 5 (5.18.6a)
FDA access to reports
FDA monitoring warning letters

2 Monitoring Report Content
ICH GCP (E 6) Section 5, 5.18.6b-c
Types of Issues documented in a Monitoring Report
GCP versus Non-GCP
GCP issues should have compliance secured by using Corrective Action and Preventative Action Plans (CAPA)
Issue/Action/Resolution format in reports

3 Monitoring Report Content
Check lists vs. narrative comments
Third person vs. first person tense
Neutral wording, facts and findings only
Documentation considerations on Key GCP areas
Source Documentation, Informed Consent, IRBs, SAEs, Protocol Violations
Documentation considerations for sites that are transferred to a CRA

4 Report Writing Drill
Review examples of good vs. bad monitoring reports and a follow up visit letter
Write a report using the concept of CAPA for GCP related issues
Writing Memo to Files relating to CAPA issues

Clinical Research
CDM – Data Management System for Clinical Research
PGDCR / MS in Clinical Research
LIMS - Laboratory Information Management Systems
Batch III PGDCR starting on 19th January 2009.
We have landed at our new CRO facility, for a sparkling start
Autoscribe UK has appointed Mithas Labs to further expand its network of business partners offering pre-sales and post-sales services for its successful LIMS, scientific and business software solutions and implementation across India.
Mithas Labs has chosen Oracle Clinical for CDM License.
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