What is QC and why is it helpful?
Many of our clients opt for Quality Control (QC) as part of their writing process. During QC, a second Medical Writer reviews and proofreads documents. Following a well-defined process, they ensure that the work is well-formatted and follows a consistent style throughout to meet regulatory standards, resulting in a smoother submission and a higher chance of success. QC shouldn’t be an afterthought. It is an important step to ensure the document is getting the message to its target audience and proving the validity of the data and conclusions.
What is usually included?
To make sure everything is included, each project receives a tailored QC checklist. This checklist covers the key areas to be reviewed. Checklists vary between documents and projects, but key areas of focus usually include:
- Final data checked against sources
- Spelling, punctuation, and grammar along with defined abbreviations
- References and links within the text
- Consistency with the provided style guide including layout and formatting
At Morula Health, we have our own library of QC checklists. This allows for variability in the scope of QCs for various documents so we can best match the requirements of our client. For example, appendices are listed in the CSR (Clinical Study Report) QC checklist, but not in the IB (Investigator’s Brochure) QC checklist.
Tips for creating a smooth QC process
Morula Health offers QC services in combination with medical writing, or as a standalone service, often supporting our clients who do in-house medical writing. Our QC process is flexible to suit different needs and has been continually refined to deliver the highest quality. Here are some tips and tricks we have picked up along the way:
Give your QC person everything they need to succeed
An effective QC process requires access to a range of resources. These include the checklist, relevant source documents, style guides, templates, the Standard Operating Procedure and most importantly, the document to be review. By ensuring your QC person has access to everything they need before the QC starts, they make the most of their time.
Don’t let QC be an after-thought
From our experience, it is easy for QC to slip down a project’s priority list, to leave it to the last minute, or to treat it as an afterthought. At Morula Health, we know this is a vital step in many projects and we accommodate this by always including it in our proposals as an optional step and discussing this in our Kick-Off Meetings to ensure the client is aware of the benefits.
Create a library of QC checklists
Having a library of QC checklists helps to standardise the process and ensures a thorough QC is performed. At Morula Health, we have created and refined a set of QC checklists that are suitable for all the documents we deal with. The relevant checklists are provided to the QC person at the start of every QC process to enable them to work efficiently.
Set clear QC expectations
To keep the process running smoothly, it’s helpful to set clear expectations before QC begins. At Morula Health we provide a QC checklist to the project client and ask them to mark the areas or scope they wish for us to include in the QC. This gets passed to the QC person, so they are aware of the expectations before they begin, and the client gets the results they expect.
Try a Kick-Off Meeting
At Morula Health, we set up a Kick-Off Meeting between the QC person and the Medical Writer at the start of our QC process. This provides a chance to discuss the background of the document and any issues that arose during the writing stage, giving the QC person the context they need to begin. In the case of a standalone QC, we have a QC Kick-Off Meeting with the client to discuss the QC checklist. This helps align everyone on the project.
Aim to maintain consistency
We aim to assign only one QC person per document to maintain consistency, which is essential for a smooth QC process.
Allow your QC person to succeed
Many QC processes take place within very tight timelines and under demanding conditions. Encouraging your QC person to take regular breaks and get enough rest to stay healthy and focused will support their well-being and allow them to perform at their best.