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• Canada – Health Canada Medical Device Incidents and 
Health Canada Recalls and Safety Alerts databases

• United Kingdom – Medicines and Healthcare prod-
ucts Regulatory Agency (MHRA) database

• Germany – Federal Institute for Drugs and Medical 
Devices (BfArM) Field Corrective Actions and BfArM 
Recommendations databases

• Switzerland – SwissMedic Field Safety and Corrective 
Actions (FSCA) and SwissMedic Recalls databases

• Australia – TGA Device Adverse Even Notification 
(DAEN) and TGA System for Australian Recall Actions 

(SARA) databases

Other Resources
Other helpful resources include SSCPs, which provide 
publicly accessible, up-to-date summaries of clinical 
data and other information about the safety and clinical 
performance of a medical device. SSCP information can be 
accessed through https://ec.europa.eu/tools/eudamed/#/
screen/home.

Thi Nguyen is a medical writer at ICON plc based in Fort 
Lauderdale, FL.

Author contact: h.nguyen15@umiami.edu

Think Like an Editor: Improving Document Quality for 
Regulatory Submissions
Speaker
Callie Compton, MA / Senior Technical Editor, Certara 
Synchrogenix, Nashville, TN

By Paris Karr, PharmD
Quality control (QC) is an integral part of ensuring accu-
rate and consistent regulatory writing submissions. QC can 
be essentially defined as a process of checking consistency 
against a standard. However, in a writing context, QC is 
more specific than just “review.”
 Considering different types of reviews (data, subject 
matter expert [SME], and editorial), the omission of each 
kind can have different implications. Data and SME reviews 
can be critical for regulatory submissions, whereas an edito-
rial review is often necessary for document appearance.
 In her presentation at AMWA’s 2022 Southeast Regional 
Conference, Callie Compton, Senior Technical Editor at 
Certara Synchrogenix, identified common issues in the QC 
process and discussed strategies for regulatory medical 
writers to ensure a successful QC process.

Common Issues
Compton began by outlining several examples of document 

inconsistency. Such instances can include (but are not  
limited to) a document not aligning with sources, incon-
sistent terminology and style conventions, and errors in 
grammar, punctuation, and/or spelling. Furthermore, she 
also identified issues that may arise downstream in the QC 
process, such as inadequate time allotted for QC, vague, 
unclear expectations and/or instructions, and misplaced 
expectations for role/review type.

Document Consistency
Compton suggested that identifying specific standards that 
govern the document is a crucial step for QC. However, 
before the actual process of QC, regulatory medical writers 
should consider asking the following questions to ensure 
document consistency:

• Does my writing align with its source(s)?
• Is my writing easy to navigate?
• Do I write about the same content in the same way?
• Do the same components in my writing look  

the same?

 Regulatory writing may often require checking exter-
nal sources such as a tables, listings, and figures docu-
ment or a clinical study report. To ensure that the writing is 
aligned with external content, it is important to clearly iden-
tify sources in the document and to keep them organized. 
Compton illustrated that source references should specify 
document identifiers, such as the study identification,  
version number, or date, if applicable.
 Consistent terminology and style conventions are also 
critical for regulatory documents. Compton pointed out  
that a style guide can be an important tool to help maintain  
uniformity when there can be many acceptable writing  
conventions. A style guide may specify, for instance,

• use of company/drug name
• preferred template/toolbar
• abbreviations/terminology, and/or

• usage (eg, patient vs subject).

 Compton elaborated that “style” may refer to 2 different 
things: writing composition or formatting. In discussing the 
latter, a QC checklist can help guide the medical writer to 
consistently perform specific assessments, line edits, and 
spelling checks as a process.

QC Process
Given its deadline-oriented and collaborative aspects, 
regulatory writing requires effective time management. 
Compton pointed out that inadequate time allotments for 
QC during development stages or at the end of a project can 
lead to considerable quality risk. For that reason, the start of 

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AMWAJournal.org     61Think Like an Editor: Improving Document Quality for Regulatory Submissions

the project is a crucial time to accurately estimate or  

prioritize time for QC.

 A writer should consider variables such as the types of 

checks needed (internal vs external), the deliverable’s page 

count, and document type. For instance, a 200-page orig-

inal protocol developed with multiple reviews involving 

an external SME may require considerably more adjudica-

tion time than a protocol amendment that only clarifies the 

study’s exclusion criterion. Compton also recommended 

that writers think about overall timeline, analyze the com-

plexity of content, and quantify available resources.

 Vague expectations and/or unclear instructions can also 

be a common pitfall in the QC process. From her editing 

experience, Compton suggested that writers be proactive in 

communicating basic QC info. Ideally, the type of review, 

specific sections (if only parts of the document need QC), 

file name/location, and deliverable due date/time should 

be clearly specified.

 Writers help delineate various roles and expectations in 
the QC process. To illustrate, a SME should provide review as 
a content expert, not editorial aspects. Compton emphasized 
the benefit of clearly establishing defined tasks between a 
writer (document author) and other collaborators.

Think Like an Editor
Regulatory medical writers can efficiently produce 
high-quality documents by applying consistency with tools 
and employing a clear starting plan with concrete commu-
nication. Moreover, continuing to ask for QC feedback and 
learning from best practices will only empower writers to 
gain crucial perspective on the QC process.

Paris Karr is a medical writer at Ethis in Winter Park, FL.

Author declaration and disclosures: The author notes no  
commercial associations that may pose a conflict of interest in 
relation to this article.

Author contact: paris@ethisinc.com 

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