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 the limited circumstances when a Memo-to-Files can be written.

• Identify the key content of a report.
• Discuss documenting using Corrective Action Plans and Preventative Action Plans for GCP issues.
• List the key documentation requirements of a monitoring report relating to GCP non-compliance.
• Recognize the writing style used for a monitoring report, the follow up visit letter, and a Memo to File.

Day 1

I. 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

II. 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

III. Report Writing Style

• Check lists vs. Narrative Format
• Third Person vs. First Person
• Neutral Wording, Facts and Findings
• Documentation considerations on Key GCP areas
• Source Documentation, Informed Consent, IRBs, SAEs, Protocol Violations
• Documentation considerations for sites that are transferred to a CRA

IV. Report Writing Drill

• Review Examples of Good vs. Bad Monitoring Reports
• Write a Report using the Concept of CAPA for GCP related issues
• Writing Memo to Files relating to CAPA issues

Anyone in clinical research that writes and/or reviews monitoring reports and follow up visit letters.

Seminar Dates	Seminar Location	Seminar Time	Seminar Fees
Register by Phone: 877-633-3322 OR Print Application (pdf) and Fax To: 954-346-2791		Accommodations Ask About Student Discount (Availability limited)

Florida State Provider #50-11408, Provider approved by the California Board of Registered Nursing, Provider #CEP 13617 for 6 contact hours. Credits can be applied to ACRP and SoCRA certification.

Cancellations by registrants must be provided in writing prior to the start date of the seminar, such registrants shall receive a credit voucher toward a future MRM seminar. Companies may substitute someone registered with another participant at any time. MRM reserves the right to cancel a seminar due to poor enrollment or acts of nature and shall not be responsible for any airfare, hotel, or other costs. MRM shall offer a credit voucher to a future seminar or a complete refund for MRM Seminar cancellations. Seminar topics and speakers may be subject to change without any prior notice.