Quanticate CRO Blog

Integrated Summary Tips

Posted by Medical Writing Team on Thu, Apr 05, 2012

integrated summary

Quanticate's Medical Writing Team have summarized tips for the preparation of comprehensive, well-written, and focused integrated summary documentation.

Integrated Summary Tips:

Worst practices for producing an integrated summary

  • Not providing one!
  • Being too brief
  • Excluding data that do not support the effectiveness conclusions
  • Excluding pertinent safety data
  • Pooling data that should not be pooled
  • Replying on results from post hot meta analyses
  • Discussing experimental endpoints, rather than focusing on primary and co-primary endpoints
  • Including datasets without explaining how they were derived

Initial preparation for authors, contributors and reviewers

  • Always ensure most up-to-date templates and relevant regulatory guidelines are consulted and used throughout the project life cycle
  • Use professional approved style guides, and detail how to cover items not covered in style guides upfront
  • Use standardized methods for citation/referencing
  • Train authors to write granular documents
  • Train reviewers to review electronically

Planning for Lifecycle Management

  • Employ methods and tools for information sharing and knowledge management early in the process
  • Reviewers need to know what has changed and why
  • Consider impact of changes on future documents
  • Incorporate best practices for change history

Improved Reviewability

  • User effective hyperlinks and bookmarks; all documents from protocol through to summary should be hyperlinked and bookmarked at time of preparation rather than at the end
  • Write with electronic review in mind – FDA Good Review Practices
  • Create an efficient work flow
  • Produce submission-ready documents at all stages – employ a consistent QC checklist to make this happen

More Integrated Summary tips will be explored in the second part of this blog.


Tags: Regulatory Requirements, ISS/ISE, FDA, Integrated Summaries, Integrated Summary of Safety, Integrated Summary of Efficacy