Quality Control of Regulatory Documents: Solving the Case
The document is complete, polished, and seemingly perfect. But is it? When performing quality control review of regulatory and clinical documents, an editor should approach each case with the assumption that a grave misdoing has been committed, one that can only be righted by brilliant detective work. Grab your deerstalker hat and we’ll review best practices to solve any document quality crimes.
Focus on the data. Data integrity is key. An editor should firstly verify that all data match the source. Check for consistency in decimal places, inadvertent transposals in values, and that all data are present and accounted for based on applicable cutoffs.
Evidence internal consistency. Does your brief summary match your text? What about your conclusions? Wait, the value in the text is not the same as the table! Inconsistency in documents can bring about unnecessary amendments. An editor should take the time to ensure that the values and information presented are the same throughout the document.
Apprehend abbreviation errors. There are bound to be changes in the introduction and use of abbreviations throughout the document life cycle. Does PD mean pharmacodynamic or progressive disease? Don’t forget to review and update abbreviations and acronyms as part of your investigation.
Inspect the formatting. I spy a different size font! Wait, are all of the footers the same? An editor should be familiar with document styles and seek out and update any discrepancies.
Don’t forget the usual suspects. Ah, our old friends, spelling, grammar, and punctuation. Was it labeled or labelled? Does that subject agree with that verb? Is that term properly capitalized and hyphenated? These culprits show up often during quality review.
While these tips will improve your document quality review, Acumen also has tools to serve as the Watson to your Sherlock, allowing editors to hone in on the key aspects to ensure overall quality. With the help of the E-Style Guide and document-specific checklists in the QC Module, unearthing quality issues becomes quite elementary.
Director of Editorial Services
Acumen