The research is done, the writing is complete, and every word in the project has been scrutinized dozens, sometimes hundreds, of times over. After so much collective effort, this must surely be the best version, right? Unfortunately, even though the study team strives to maintain quality throughout every step of clinical studies, research documents must also be inspected for accuracy and integrity towards the end of the process in order to prepare them for submission to regulatory authorities. The careful eyes of a Quality Checking (QC) expert are required to notice and correct errors that might otherwise render all the writer’s and researchers’ work unpublishable.
The QC process is complex and highly specific, ensuring that documents submitted to regulatory agencies contain the most up-to-date information, are internally consistent, and conform to regulatory guidelines. While this may seem intuitive, untrained eyes may miss details that can distort or even invalidate the presented scientific research. The best way to ensure the highest quality of published materials is to enlist the expertise of a QC specialist. Regulatory guidelines are easiest to follow if they are implemented as early as possible, so there may be more than one round of QC depending on the level of complexity of the materials and the number of drafts or rewrites.
Many QC professionals have checklists that vary in content for each type of document they encounter. For example, a checklist for clinical study reports (CSRs) does not make sense to use for narratives. A common practice is to provide a signed copy of the checklist used for a project at the end of the QC process. Each list is divided into subsections to make sure nothing is missed. Internal consistency, a term that covers several facets of any document, is one of the most important of these subsections. When information in one section needs to be changed or updated, oftentimes references to that information that appear in other places throughout the document are forgotten. For example, this happens often with the consistency between the synopsis and the text body. Other examples of QC checks might include completing a List of Abbreviations, ensuring all data is accurate and correctly sourced, checking that all sections of a document are present and properly written according to E3 or E6 guidelines, and updating cross-references between different sections in the document. Because CSRs undergo several cycles of comments, rewrites, and updates, they are especially prone to errors, and require a meticulous and practiced eye to ensure a comprehensive check.
After the implementation of QC findings, the document(s) can be published in accordance with regulatory requirements. Accurate documents facilitate effective communication with regulatory authorities, saving time and resources on the way to approval.
Written by:
Marshalle Grody
Quality Checking and eCTD Submission Associate