The Clinical Study Reports (CSRs) are the critical documents by which regulators can assess the outcome of clinical studies. CSRs also include Clinical Trial Reports – the new EU terminology for CSRs when the study report pertains to an interventional (rather than non-interventional) trial.
CSRs are scientific documents addressing efficacy and safety, not a sales or marketing tool. But the sponsoring company’s goal is to sell a drug, biologic, or device. Sponsors want to showcase a product and the problem it solves, and they want regulators to focus on the forest, not the trees, to weave key messages with important study findings that are repeated throughout the marketing application. In the CSRs, key messages are found in the synopsis at the beginning and are reiterated in the body of the document as topic sentences, in summaries of sections or
subsections, and in the conclusions. Sponsors hone key messages thoughtfully, selecting words and ideas to convey desired nuances. Although study findings determine key messages, messages may be influenced by other factors such as results of prior studies and characteristics of competing products.
CSRs for submission to the Health Authorities are also required to be in compliance with the International Conference on Harmonization (ICH) standards and must meet high quality standards. Participants will learn the elements of the CSRs and the appendices, methods for turning the protocol and statistical outputs into one cohesive document, the basics of writing and preparing a document for submission, and the guidance’s to follow for reference. The course will provide latest strategies for preparing such clear, well organized, ICH-compliant CSRs in a most efficient way.
Who is the course aimed at?
This one-day course is intended for professional’s researchers and medical doctors in the biomedical field, including, but not limited to employees of Biotech and/or Medical Device companies, Pharmaceutical companies, CROs, Consultants, Research hospitals, Universities, as:
• Medical Affairs Professionals
• Regulatory Professionals
• Clinical Operations Professionals
• Clinical Study Managers
• Medical Writers
• Scientific Communications Professionals
• Medical Communications Professionals
• Representatives of academia running clinical trials
who are involved in clinical research and need to write clinical study reports.
• Welcome and objectives
• What is medical writing
• Regulatory requirements – CSRs
• Study Documents I Read Before Writing a Clinical Study Report
• The structure of CSR
• Title page, abbreviations, definition of terms, ethics, investigators
• Introduction, study objectives, investigational plan, study patients, efficacy evaluation, safety evaluation
• Discussion, overall conclusions, tables, figures, graphs, appendices
• The synopsis
• Workshop: where are infos?
• Closing remarks
The course is designed for anyone who knows the basics of clinical research and scientific publishing being interested in presenting their results to regulatory authorities.
At the end of the training, you will be able to:
- Recognize key regulatory requirements for clinical study reports
- Understand the relationship of the clinical study report to the clinical study protocol
- Develop a comprehensive and easily reviewable clinical study report
Andrea Rossi, Medical Writer – European Medical Writers Association
Andrea Rossi has a degree in Biology from Florence University. After a brief spell at the University, he started working in the Italian Affiliate of Eli Lilly as a Clinical Research Associate. In the years that followed he was responsible for Statistics, Health Outcomes and Medical Information. Andrea has been working in Medical Writing since 2003. He is author of more than 350 disclosures and acknowledged for his contribution in several others. From 2007 to 2009 he was on the coordination board of BIAS (Biometristi Italiani Associati) and has been an European Medical Writers Association (EMWA) member since 2004. Andrea leads workshops for and is past-president of EMWA.
Andrea acts as trainer for statistics and medical writing in some Italian schools for specialization in medicine, and has been a speaker at national and international conferences.