How to Write Effective Monitoring Reports and Communications

Clinical Monitors (CRAs) must document many details of the happenings at investigational sites, including Confirmation Letters to sites, Monitoring Visit Reports, Follow-Up Letters to sites, Telephone Contact Reports, Email/Faxes to sites, and Queries and Notes to File (NTF). All of these become essential documents as they demonstrate the compliance of the monitor and, thus, the sponsor in the conduct of the clinical trial. These are all eligible for inspection by the regulatory authorities at any time both during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics, and devices. Effective writing skills are, therefore, extremely important so that we show the diligence and detail involved in effective monitoring. Increasingly, we notice that the Confirmation Letters, Monitoring Visit Reports, and Follow-Up Letters have discrepancies. This may be simple date inconsistencies, or critical data credibility issues. It is important that the monitor be aware of the importance of these issues in the review of study documentation. This module will provide some practical solutions to addressing document deficiencies as well as provide a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor.

The monitor visit starts with a well-written Confirmation Letter informing the investigator and investigator’s staff of the expectations of the upcoming visit. An accurate and complete Monitoring Visit Report details all of the activities of the monitor in meeting the sponsor’s obligation during the actual monitor visit, including action items and demonstrable management of the site by the monitor. Queries must be well-written if they are to be understood by the study coordinator or Principal Investigator at the site. The Follow-Up Letter, which must detail the progress made on this visit and highlight any deficiencies for which the monitor expects resolution must agree with the action items listed in the Monitoring Visit Report. Written documentation of Telephone Contacts must be direct, accurate, and timely; other communications between monitor visits need to be associated with the proper events as well. This module will provide an understanding of the information required, importance of timely and well-documented discussions, and proper methods of filing this key documentation. This workshop is invaluable for the CRA as well as the individual who critiques the various reports.

• Describe the requirements of documenting monitoring activities
• Implement strategies for effective writing outside of the monitor visit
• Effectively manage site and sponsor activities and document them appropriately
• Recognize the importance of a well written Monitoring Visit Report
• Evaluate well-written and poorly-written material from actual studies
• Identify the appropriate use of Notes to File in both patient-related and study-related situations
• Write effective documents for various types of monitor visits

• Clinical Research Associates/Monitors
• Lead Clinical Research Associates
• Contract Clinical Research Associates
• Clinical Research Associate Managers
• Project and/or Study Managers
• Project and/or Clinical Trial Assistants
• Quality Assurance Personnel

Gary B. Freeman, M.S.

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Day 1: 9:00 a.m. – 4:00 p.m.

• Confirmation Letters, Follow-Up Letters
• Queries, Monitoring Visit Report
• Communication Outside the Monitor Visit (telephone, email faxes, Notes to File)

• Review a Monitoring Visit Report and evaluate examples of well-written and poorly written documentation of issues, deviations, and action items for follow-up
• Write sections of a Monitoring Visit Report based on a scenario provided
• Draft a Follow-up letter given some issues to review in the Monitoring Visit Report
• Critique Confirmation and Follow-up letters 
• Discuss the importance of providing consistent information
• Critique a Telephone Contact Report
• Discuss the value of proper filing of documentation related to the visit but conducted outside of the actual visit Review several scenarios and associated NTFs and evaluate if the NTF was the most appropriate manner for managing and documenting the issue 
• Learners are encouraged to bring specific work-related document samples for evaluation in light of best practices and GCP standards 

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day. 

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings. 

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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 6 hours (0.6 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE# 0778-0000-16-046-L01-P. Released 11/16. 

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For more information, contact Naila Ganatra at (215) 413-2471.