Integrated Summary Tips
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.