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The QC Process for CSRs

By Danielle Hadar

When starting QC work on a document, I first look through the entire document and its formatting to see if anything is out of place, whether the heading numbers are correct according to the E3 ICH Guidelines or if they need to be reorganized, and if the tables and figures are sequentially numbered and properly spaced. I look for incorrect font sizes, paragraph spacing, and even floating headings, which I make sure properly follow their corresponding content.

Once the document is consistently and correctly formatted, I begin checking numbers. This requires all the TFLs that were used in the writing of the document. I start with the tables, meticulously checking each number against its source, making sure that if I do find any errors, I make a comment with all the necessary details so the writer can apply any fixes quickly and efficiently. Along with this process, I also confirm that all the sources listed are true to their in-text tables, looking at table titles as well as the information presented in the table itself. This last step is also done for any figures that are presented in the document; every external source is confirmed.

Once the tables in the document are confirmed against the sources provided, I move on to the numbers that are presented in the text. Some numbers are pulled from in-text tables, and some are found solely in TFLs. Regardless, all are checked and if a mistake is found, I leave a comment with the corrected information.

The next part of my workflow is checking consistency of the information presented. First, I look at the Safety and Efficacy conclusions against their entire section, respectively, and make sure the information presented by the writer is accurately found within the document. Second, I look at Section 13, Discussion, making sure once again that the information included there can be confirmed by the information brought up in the report and that any numbers presented are correct. Third, I compare the synopsis to the entire report; title, objectives, inclusion and exclusion criteria, and anything else that goes in the synopsis is checked and confirmed. If anything is presented in a way that is not consistent with the report itself, I leave a comment for the author with text and section I compared it to.

I also look at grammar and spelling in the text, as this is the time I truly get to read the report.

Once the consistency check is done, I make sure all references cited in the report are properly listed in Section 15. It isn’t uncommon for the reference list to have unreferenced sources; these all get a comment to allow the author to address this issue. I also make sure that the abbreviation table is updated and covers all abbreviated terms found in the document.

Finally, I go over the entire document again, this time confirming that all links work properly. With this I also make sure to update the Table of Contents, List of Tables, and the List of Figures, checking that they are hyperlinked, as sometimes this option is not set correctly.

Then, my work process is complete, I take a step back, look over the entire QCed document one last time, and send it off to its author.