Sunday, December 13, 2009

Effective Medical Writing for Clinical Submission #3

Focus, create and develop templates early and communicate processes and procedures to medical writers and all team members. Submission medical writers who are experienced must lead this effort since they have the ultimate responsibility for the overall quality of the final document. The direction is simple and if followed religiously, the final document will be content final, with accurate, consistent data, ready for publish, ready for submission, ready for FDA.
  • Focus all writers, all teams, nonclinical, clinical, CMC, CP, CRO, Sponsor, Outsourced Submission Teams, etc., early in the development of the submission document pertaining to agreed upon processes and procedures
  • Adhere to the processes and procedures - do no deviate - if a deviation is considered, quickly inform all team members - the deviation will undoubtedly impact subsequent documents
  • Work with Outsourced Quality Control consultants early in the process to ensure accurate document versions and data versions across all functions, across all documents
  • Establish an agreement on a storyline early in the development of the submission document
  • Do not deviate from the agreed upon storyline once set and communicate the storyline to team members and medical writers - this storyline will be written in numerous documents and cited often in the overall submission - stay with one storyline for consistency and to drive the benefits of the drug to the reviewers at FDA
  • Create submission documents shells early in the development of the TOC - documents shells, populated with data or not, can provide useful information pertaining to electronic hyperlinks, size of submission, how many programmed tables, listings, graphs and figures per document, how to provide submission document and content crosslinks, etc.
  • Develop the submission document format, writing styles and submission and publish ready templates early and consistently across all submission NDA Sections and CTD Modules 1-5.
Good medical writing and good, clear, concise content - is a team effort. Communicate. Enforce Quality and Consistency Processes and Procedures. Track and review the progress of each document frequently. Lead the submission team and project manage document issues!
More to come...

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