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Integrated Summary Tips

  
  
  
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.

 

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