Effective Medical Writing for Clinical Submission #2

Once the clinical submission team establishes (with FDA) a TOC for the clinical filing, responsibilities and accountability's are assigned to medical writers. Who will write which documents? Will the documents be written by the sponsor? Will the documents be written by the pharma's functional areas? Will the documents be written by the CRO? Or will the documents be written by consultants, members of a high level medical writing project/clinical submission team asked to participate (outsourced) by the pharma?

It is strongly advised that writing decisions and assignments do not change mid-stream - adhere to a decision that there is one author - and that author is responsible and accountable for each assigned document from start to finish, submission ready, publish ready through final sign-off.

Simple considerations to establish early...

• Who is responsible from each function, if a function task, if a consultant, if a medical writing team?
  
• Who is accountable from each function, if a function task, if a consultant, if a medical writing team?
• Establish clear reporting and responsibility lines of communication, for data questions, for issues, for progress, for status!
• Clarify writing responsibilities, who will write, who will review, how many reviews?
• Clarify who will QC, who will review the QC findings, who will implement the QC findings, who will track the QC findings, how to track the QC findings, how many cycles of QC?
  
• Clarify ownership of the documents as a whole, to ensure consistent, data accurate, submission ready, publish ready, template accurate, storyline correct, documents with continuity and completion endpoints!
  

In my opinion and historically, since clinical submission documents are frequently complicated with data, hyperlinks and statements, outsourced medical submission writing teams should be engaged by the pharma - these medical writers must be leaders in the respective subject, be proactive (and diplomatic) in soliciting information from sponsor functions, which include but are not limited to, biostatistics, project management, data management, nonclinical and clinical functions, CROs, experts and QC. The medical writer drives the document to completion not clinical or regulatory team participants. The medical writer must work early in the development of the document template with programmers, QC and submission publishers to ensure submission ready and publish ready documents at completion and final sign-off.

More to come...