Thursday, December 10, 2009

Effective Medical Writing for Clinical Submission #1

Effective, which means, cost, time, effort, quality-controlled, quality-assured, consistent, accurate, version correct, data-driven, GCP-driven, process and procedure adherent, medical writing for clinical submission will follow these parameters early in the development of a document to be written...

Consider all documents and components, for examples, appendices, narratives, TLGFs, required for the clinical submission...
  • a clinical submission for a drug for example has 5 CTD Modules, "what documents and document components are to be written"? Develop a TOC!
  • a clinical submission will require a format, "what format will be followed"? CTD? Legacy NDA? 505 (b)(1) or (2)? Choose a format!
  • a clinical submission will require source documents to support the written documents, "what are the source documents, which will be included in the clinical submission"? Develop a TOC that reaches this level of granularity!
  • a clinical submission will require a team effort between writers, QC, QA, sponsor functions, experts, CROs, etc., "what is the process for file and information transfer between team members onsite and offsite, inhouse and remote"? Develop a process and procedure! Adhere to the process and procedure throughout the clinical submission! Communicate the process and procedure to all team members!
For effective medical writing for clinical submission, these are important points to consider early in the process.

More to come...

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