Your Document’s Path to a Successful Quality Control Review

Prepare for a successful Quality Control review! Download this poster, presented by Synterex at the 2023 American Medical Writers Association (AMWA) conference, or scroll down for a text-only version.

Thumbnail of the QC Readiness poster

 

Quality control (QC) specialists typically have an established process for reviewing documents, but the path will be hindered if background information needed from the medical writer is incomplete or missing. This poster provides guidance for medical writers on making their documents QC ready. Having these elements in place will also benefit peer reviewers even before the QC process begins!

Give Sources in Annotations

Often, text and data in a document are pulled from outside sources—other documents, tables, and lists. Write clear and complete annotations, using the comment feature in Word, to reference each source. Annotate as you write to save time later. This allows the QC reviewer to check the text against its source material and correct any discrepancies.

How to write a good annotation:

  • Highlight the relevant text.
  • Write out the full name of the source file or include a direct link.
  • Describe where in the source document the relevant text can be found (e.g., section, page number).

Organize Source Materials

Within the QC draft folder, set up a source folder in which you will put a copy of, or a hyperlink to, each source referenced in the document. Do not include multiple versions of a file. Check to make sure files open properly.

Highlight Nonstandard Elements

If the document contains any unconventional style elements or intentional deviations from the client’s style guide, leave a comment letting QC know. Consider making a style sheet that summarizes these nonstandard elements.

Examples:

  • British English is used instead of American English.
  • Gene names are intentionally not italicized.
  • Text or data from a source document is intentionally changed or left out.

Perform a Final Check

Although QC will check these items thoroughly, their role is to catch exceptions, not to rewrite a document. A precheck will ensure you have done everything you intended to do and will allow QC to focus on substantive elements and consistency.

Table of Contents:

  • Check that page numbers are accurate.
  • Make sure all frontmatter (e.g., list of abbreviations) and backmatter (e.g., appendices) are included.

Headers and Footers:

  • Make sure the format is correct according to the style guide and it is consistent on all pages.
  • Ensure all pages are numbered correctly.

Hyperlinks:

  • Ensure that all internal hyperlinks to tables, appendices, references, etc., are functional and link to the correct places within the document.
  • If external hyperlinks are functional, ensure they link to the correct place; if hyperlinks will be added later, flag this for QC awareness.
  • Update field codes.

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