ASSIGN ACADEMY

Effective Clinical Study Report Writing

The Clinical Study Report (CSR) is a critical document in the drug development and regulatory submission process. This short seminar will introduce you to the basic tools required to generate CSRs for the pharmaceutical industry. Participants will learn the elements of the CSR and the appendices, methods for turning the protocol and statistical outputs into one cohesive document using document templates, the basics of writing and preparing a document for submission, and the guidances to follow for reference.

The Clinical Study Report (CSR) is a critical document in the drug development and regulatory submission process. This short seminar will introduce you to the basic tools required to generate CSRs for the pharmaceutical industry. Participants will learn the elements of the CSR and the appendices, methods for turning the protocol and statistical outputs into one cohesive document using document templates, the basics of writing and preparing a document for submission, and the guidances to follow for reference.

On completion of this half day course you should be able to recognize key regulatory requirements for integrated and abbreviated clinical study reports. You should also be able to explain the format and structure of a clinical study report and describe the relationship of the clinical study report to the clinical study protocol. You should also be able to address issues related to patient disposition, compliance, and statistical methods to deliver a comprehensive and easy to review clinical study report.

Areas covered will include:

  • Structure and format of a clinical study report in accordance with ICH guidelines
  • Investigational plans using statistical methodology
  • Study population and protocol deviations
  • Placement and presentation of study information and data in various report sections including tables, appendices, and supporting documentation
  • Safety and efficacy results
  • Pharmacokinetic and/or pharmacodynamic endpoints -

 

Speakers:



Anna Durance-Bagale


Anna, House Editor at Niche Science and Technology Ltd, has been with the company for 10 years. A highly experienced regulatory writer and editor with a background in neuroscience, Anna has written and/or edited hundreds of regulatory documents for a comprehensive list of pharmaceutical companies. Over the last 10 years Anna has written over 200 clinical study reports.

 


Tim Hardman

Tim, Managing Director at Niche Science and Technology Ltd, started the company in 1998. A highly experienced regulatory writer who has written over 100 clinical study reports, Tim plays an active role in the training of writers and reviewing their development. Tim still loves writing and continues to publish articles in the scientific literature particularly in the field of diabetes and metabolic disease.

Price: 75 €