Effective Medical Writing for Clinical Submission #5

Yes, there is the document type and the timelines to consider, now lets look a bit more into the review and QC cycles involved in the development process of the document.
Important points to consider:

• Clearly define the objectives and the process to be followed during the actual review and QC
• Who on the clinical and project submission teams are involved in the review and the QC - of course the medical writer and the QC data controller are involved throughout the lifetime of the document under development
• How many review cycles are needed
  
• How many QC cycles are needed
• How will the review comments be tracked
• How will the review comments be resolved
• Who will resolve the review comments
• Check to see if the review comments are implemented and implemented correctly
• Follow the same considerations for outlining the process for QC comments
• For each review and QC cycle, no comment should be left without resolution - this includes, data, text, statement, interpretation, conclusion or an action item
• Submission medical writers and QC data consultants must always interact directly with clinical or expert decision makers in resolving comments and QC findings - this to avoid uninformed intermediaries that may not have credible, accurate, decisive resolutions to positioned comments.

In order to move a document ahead, each review and QC cycle must not leave open-ended comments and both medical writer and QC consultant must be able to close out the comment, complete the resolution and implement the change to the document - by using a tracking tool which archives the change, the reason for the change, the source of corrective action, date of change, the version of the document changed and of course the data changed - the comment is then signed off and initialed by the MW and QC. The comment is not to be revisited. The next document will reflect the implemented correction.

Moving the document ahead with Quality is essential. Changes must be tracked and resolved. Lead the team and manage the comments, track the resolutions.