Saturday, December 19, 2009

Effective Medical Writing for Clinical Submission #4

When preparing clinical submission documents two parameters must be considered. One, the document itself and two, document timelines. The latter is in some instances more important and more difficult to achieve. Yes, the document must be completed according to GCP, ICH, FDA and CTD requirements and guidelines. However, the document must be completed with a timeline in mind as well. This timeline is integral to the rest of the clinical submission because the message and content of each document builds on each other as the writing team climbs the clinical submission pyramid, from CTD Modules 3,4,5 being the foundation of the clinical submission pyramid, Module 2, backbone and Module 1, the peak of the pyramid.

Important points to consider with clinical submission document timelines - what the clinical, project submission and medical writing teams must develop and adhere to for each document prepared and written:
  • Are the document timelines realistic
  • Implement periodic clinical and medical writing team meetings to ensure that the timelines remain realistic
  • Implement measures to communicate the progress of each document vs timelines
  • Ensure that each medical writer and quality data controller gets accurate, quality source documents to develop the document content
  • Ensure that each medical writer and quality data controller gets accurate quality tables, listings, graphs and figures (TLGFs) to develop the document content
  • Ensure that each medical writer and quality data controller gets source documents and TLGFs on time for a start date to begin writing - the clock starts
  • Ensure that each medical writer and quality data controller gets a complete set of source documents and TLGFs
  • Ensure that each medical writer and quality data controller gets the correct, most up to date version of the source documents and TLGFs
  • Build in useful, meaningful and appropriate team reviews
  • Build in useful, meaningful and appropriate cycles of QC
  • Build in a realistic sign-off final date.
Monitor and project manage each document and each step of document development vs a timeline.

Measure metrics on completion vs progress and impact to the overall timeline of the clinical filing and clinical submission. Lead the people, project manage the documents, control the quality of the data. Keep timelines realistic. Ensure timelines.

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