Industries: Pharma / BiotechMedical Device

Writing Effective Monitoring Reports and Good Documentation Practices: A Symbiotic Relationship

Course Director: Lee Truax-Bellows

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

One common Sponsor regulatory inspection finding is inadequate monitoring. When an internal audit or regulatory inspection occurs, the first thing that is requested is all written documentation. The adequacy or inadequacy of monitoring can be demonstrated and assessed in a number of ways but one manner where this occurs is through review of written monitoring communication. While communication can be both verbal and written, written documentation is of greater concern as it forever documents actual or potential issues for all to see and from which they draw conclusions. Poorly communicated goals, assessments and results can reflect poorly on a clinical study. In addition written communication is the basis for planning current and future actions and can impact policies, procedures, and overall project conduct. Poor communication can result in misinterpretation, need for re-work and a loss of productivity at both the sponsor and site level. Among other skills, excellent communication can help lead to excellence within the project itself.

This course will provide direction on what excellent communication skills entail and how it results in quality work when combined with good documentation practices. It will demonstrate what is needed to produce effective written communication in support of a clinical trial. It will provide practical advice on effective writing skills, good documentation practices and how these relate to inspection/audit findings. Practical examples and exercises, e.g., developing and writing effective monitoring reports, will be performed by the participants to guide them on producing concise, clear written communication as it pertains to monitoring efforts. In addition it will demonstrate how management can use written communication to assess monitoring activities. The session is geared towards introductory and intermediate participants at the sponsor level who are interested in developing their written communication skills.

Who Should Attend

This two day course is designed for professionals involved in clinical trials. It is primarily designed to benefit the following disciplines and personnel:

  • Monitors (CRAs)
  • Project Managers
  • Other interested Clinical Affairs personnel

First Day

Pre-course Test

Introduction to Good Documentation Practices

  • Definition of a Document
  • Basic Principals of Good Documentation Practices
  • Documentation Creation
  • Accuracy of Documentation
  • Completeness of Documentation
  • Legibility Principals
  • Document Control
  • Traceability
  • Document Maintenance/Retention

Ramifications of Ineffective Monitoring Communication

  • Review Warning Letters

Documenting Monitoring Communication

  • How varied monitoring communication fits with company's existing standard operating procedures and policies
  • Telephone
    • Documentation
  • Email Communication
    • Etiquette
    • Regulatory Ramifications
  • Letter/Fax Communication
    • Minimum contents

Risk-based Monitoring

  • Review of FDA guidance on risk-based monitoring
  • Impact on monitoring communication
  • Predefining types of documentation for "remote" versus "centralized" monitoring activities

Q&A Period

Second Day

Recap of 1st Day of Course / Q&A

Monitoring Documentation

  • Monitoring Plans
    • Purpose of Study-specific Monitoring Plans (MPs)
    • Developing an effective MP
    • Adjusting the MP
  • Communication Plans
    • Purpose of Study-specific Documentation Plans (DPs)
    • Developing an effective DP
    • Adjusting the DP
  • Confirmation/Follow-up On-site Monitoring Visit Letters
    • Purpose of On-site Monitoring Visit Letters
    • Developing effective On-site Monitoring Visit Letters
    • Visit agendas
    • Revising Letters
  • Monitoring Reports
  • Purpose of Monitoring Reports
  • Types of reports
    • Site Qualification Visits
    • Initiation Visits
    • Interim Monitoring Visits
    • Close-out Visits
  • Concept of 'Closed-loop Monitoring'
  • Developing an effective Monitoring Report
  • Revising reports

Q&A Period

Learning Objectives

By the end of the course, participants will be able to:

  • Describe the goals of effective communication
  • Describe and demonstrate the principals of good documentation practice
  • Relate good documentation practices to effective communication
  • Describe the relationship between effective communication and effective monitoring reports
  • Develop effective monitoring reports and related documentation