May 15, 2018 | Nancy Gasper-Smith, PhD, RAC, Consultant, Medical Writing and Submissions Management and Head of Quality Control │ Medical Writing Services
Quality control (QC) is a term that applies across many industries. Within the field of regulatory medical writing, QC refers to the process of ensuring the quality and accuracy of a final medical writing deliverable.
In this post, I hope to answer many of the questions that our clients often ask us, such as: Why QC? What does QC entail? When should it occur? Who should QC?
The “why” of QC is straightforward – our goal is to deliver a document of the highest quality to our customers and it’s required by the guidance set forth by the International Council for Harmonisation (ICH):
“The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.” ICH E6: Guideline for Good Clinical Practice
The “who, what, and when” of QC are a little harder to define. What is QC? When should QC occur? Who should QC? As a regulatory medical writer who both writes and QCs on a daily basis, as well as leads the Quality Control department at IMPACT, I’m hoping I can shed some light on these questions.
What is QC?
The primary purpose of QC is to verify accuracy of 100% of the data presented in the document. That sounds easy enough, right? But there is more to it than some people may think.
When I QC a Clinical Study Report (CSR), for example, I check each and every number the author presents (both in the text of the document and in any in-text tables) against a verified, approved source (typically, the final tables, figures, and listings provided by the study statistician). This QC includes confirming that the interpretation of the data is correctly stated in text.
But QC activities at IMPACT extend much farther than number checking. A QC of any document should include:
- 100% data QC (all data verified against a source);
- Confirming that non-numeric information presented reflects the source (eg, protocol, statistical analysis plan);
- Ensuring consistency of appearance and adherence to an agreed‑upon style guide (whether from the Sponsor or IMPACT);
- Checking for consistency of presentation, format, grammar, use of abbreviations (and the list of abbreviations, if present), references cited; and
- Confirming cross-references in the document are correct.
It’s these “soft” aspects of QC that are sometimes missed by the untrained eye. However, we think these are crucial for regulatory documents, which are often the culmination of many years of clinical development on the part of the Sponsor!
When in the Development of a Document Should QC Occur?
Whenever we are asked this question by a potential client, our answer is always “as early as possible” once the final source documents are available.
Using the example of a CSR, we typically start writing the “shell” (sections of the report that present study conduct and statistical analyses) long before database lock. At this stage, there are no data to present, but all of the text from the approved protocol and statistical analysis plan used in the report can undergo QC. When the next draft is being developed, only new text/data have to be checked and the QC burden is reduced substantially.
Who is Qualified to Perform QC Activities?
The most important part of the “who” question is actually who should NOT QC. The QC should never be performed by the author and should not be performed without appropriate training.
- Why not the author? The document deserves a fresh eye. Data errors, grammatical mistakes, and formatting are often missed when an author has had the document in front of him/her for days or weeks.
- What is appropriate training? Here at IMPACT, our QCers are taught how to QC through formal classroom training in combination with QC exercises.
- Who documents the QC? Standard Operating Procedures (SOPs) vary across companies, but at IMPACT, the QCer provides their findings to the author (via hardcopy or electronically) who documents the completion of the QC with a signed and dated form (that is subsequently archived and stored electronically). Electronic document management systems can also store documentation of QC.
What Are the Elements of Managing a QC Department?
Management of a QC process can vary. Some companies may have a dedicated QC department, others may have their writers QC, and others may use contract QCers. At IMPACT, we use a combination of all three. So what are the elements of managing a QC department?
- Efficiency: It all starts with the medical writing team. We encourage “clean” writing from the start. A clean document allows the QCer to focus primarily on the data (then secondarily on things like capitalization or style). The use of document templates and well-developed style guides promotes clean, consistent documents across a project. Stay tuned for a post on style guides!
- Proactive resourcing: At IMPACT, our medical writers use a web-based system to schedule a QC for each draft of a document as far ahead of time as possible. This allows us to create the most efficient match with document to QCer. Ideally, the QCer has familiarity with the project (the subject matter, the style guide, the data presentation) and hits the ground running when they start the task.
- Building a strong team: While we, as medical writers, still QC each other’s work, we also have contract QC specialists on our team who undergo the same QC training as our writers and serve as a valuable resource for QC during our busy periods.
Do You Need QC Help?
IMPACT has developed a thorough QC process, and each and every document we write undergoes a rigorous check in adherence with our QC SOP. We have also provided QC training as a service to our clients and we’re happy to help you, too! Please contact us.
Category: Medical Writing Services
Keywords: Quality Control, Medical Writing, Regulatory Medical Writing, Medical Writer, Regulatory Medical Writer
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