Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans

Why Should You Attend:

The FDA’s recent “Guidance for Industry Oversight of Clinical Investigations— A Risk-Based Approach to Monitoring” requires for each clinical trial that the sponsor should develop a monitoring plan to describe the monitoring methods, responsibilities, and requirements of the trial. The EU EMA reflection paper 'Risk based quality management in clinical trials' (2013) also recommends that sponsors should prepare and maintain monitoring plans for all clinical trials.

The webinar has been specifically designed to learn how to write and use monitoring plans, and generate a system for training and implementation of effective and compliant monitoring procedures. It will assist attendees prepare for inspection of monitoring plans. This knowledge is particularly important given the recent new regulatory requirements for monitoring plans in both the US and EU.

Areas Covered in the Webinar:

• Understand regulatory requirements for the creation, compliance, maintenance and revisions of monitoring plan
• Understand the FDA and EMA requirements for the components of a monitoring plan
• Implement compliant processes for monitoring plan requirements for clinical trials
• Gain insight into expectations for an effective monitoring plan documentation including non-compliance or revision of monitoring plans
• Understand roles and responsibilities of who should be involved in the monitoring plan process to ensure compliance with regulatory requirements
• Comprehend the latest FDA and EU expectations for monitoring plans
• Learn how training and implementation of the monitoring plan should be carried out to meet inspectors expectations

Who Will Benefit:

This webinar will provide critical assistance to those in FDA regulated companies including professionals in pharmaceutical, biotechnology, CRO, SMO, vendor companies, or study sites with investigator initiated studies that are subject to inspection or audit of their monitoring plans procedures, including those moving towards electronic monitoring plan.

• Drug research and development managers and personnel
• Monitors
• Clinical research associates (CRAs)
• Clinical research archiving and document management personnel
• Clinical project managers
• Quality assurance managers and auditors
• Clinical development managers and personnel
• Phase I units
• CROs
• Project management
• Sponsors and non-commercial sponsors
• Sponsors who have their own laboratories for analyzing clinical trial samples
• Consultants
• Document management
• Legal, regulatory authorities and all other professionals who want to know more about inspection of monitoring plans
• Investigator sites
• Investigator initiated trials

Instructor Profile:

Dr. Laura Brown, PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. She is a managing director with LB Training and Development Ltd., course director for the M.Sc. in Clinical Research, School of Pharmacy at the University of Cardiff, and course director for M.Sc. Regulatory Affairs, TOPRA.

Dr. Brown has 20 years’ experience running clinical trials and clinical quality assurance in the pharmaceutical industry, and auditing clinical trials internationally. She has held a number of international and senior management QA positions in the pharmaceutical industry including her role as an associate director with a leading GCP audit consultancy. She has worked for several international companies like GlaxoWellcome, Hoechst Marion Roussel and Phoenix International.

Dr. Brown has penned a chapter on training QA staff in the leading GXP book “Good Clinical, Laboratory and Manufacturing Practices” (2007). She has authored SCRIP’s latest GCP guide and one entitled “Practical Guide to the Clinical Trial Directive”. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and in training courses on inspection and quality issues inspection and quality issues.

Dr. Brown developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (a regulatory commercial e-learning training organization) in 2008 and is editor of an e-learning SOP series for Henry Stuart Conferences (2013), which includes ensuring informed consent meets regulatory requirements.

She runs many training courses on topics such as: pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, GCP, regulatory requirements for clinical trials, the clinical trial directive, managing clinical trials, QA management and business skills, how to prepare for audit and inspection, how to audit, etc.

Topic Background:

A monitoring plan is a document that describes the specific monitoring procedures to be undertaken for a particular trial. This would typically include:

• The extent and nature of monitoring to be employed
• The responsibilities of those involved
• The procedures for monitoring reports and for dealing with issues raised

The monitoring plan should include a brief description of the study, its objectives, and the critical data and study procedures, with particular attention to data and procedures that are unusual in relation to clinical routine and require training of study site staff.

The plan should also communicate the specific risks to be addressed by monitoring and should provide those involved in monitoring with adequate information to effectively monitor clinical trials.

All sponsor and CRO personnel involved with monitoring, including those who review or determine appropriate action regarding potential issues identified through monitoring, should review the monitoring plan and associated documents.

Preparing and ensuring the monitoring plan is revised where needed, the sponsor should ensure the monitoring plan complies with the applicable regulatory requirements, and should adhere to FDA and EU GCP principles. These GCP requirements have recently expanded with the FDA and EMA guidance’s on monitoring – particularly risk based monitoring approaches which should be included in the monitoring plans.

The lack of or inadequate monitoring plan are now becoming a common FDA and other regulatory inspector’s inspection observations and may become of increasing focused on by inspectors due to the recent additional requires in this area. Findings with monitoring plan are often caused by inadequate preparation of the content and inadequate processes for implementing and revising monitoring plans.

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