





































 V38 N2 / 2023 

©2023 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     13

Monica Nicosia, PhD / Nicosia Medical Writer LLC, Bryn Mawr, PA

A Medical Writer’s Guide: Working on Clinical Research Manuscripts 
for Submission to Peer-Reviewed Medical Journals

THEME ARTICLE

ABSTRACT 
Prompt publication of clinical trial results in peer-reviewed 
journals is essential to advance clinical practice and improve 
patient outcomes. The involvement of professional medical 
writers (PMWs) in the preparation of these clinical research 
manuscripts can enhance their quality and shorten publica-
tion timelines. Research manuscript projects can be daunt-
ing, especially for early-career PMWs who could benefit from 
insights provided by experienced PMWs. In this guide, first  
I share my perspective on how PMWs contribute to such 
projects and the essential skills and competencies we should 
provide. Then, I describe my tactical approaches to initiating 
these projects, developing the first draft of a detailed outline 
or manuscript, and avoiding some common pitfalls that can 
undermine the quality of a manuscript. Finally, I share some 
tips for working with challenging personalities.

There are many types of biomedical research manuscripts 
(Figure 1).1 Research manuscripts that report the results of 
clinical investigational studies are among the most impact-
ful articles published in peer-reviewed biomedical journals. 
Prompt publication of clinical trial results is essential to 
facilitate discussion of their implications for clinical prac-
tice and any potential improvements in patient outcomes. 
However, because clinical investigators need to balance 
clinical, research, and other responsibilities, they usually 
have limited time to prepare manuscripts for journal sub-
mission. Their junior medical colleagues often have even 
less time and less training in writing scientific manuscripts. 
The involvement of professional medical writers (PMWs) in 
the preparation of research manuscripts can improve their 
quality and shorten publication timelines.2-4 In this context, 
PMWs lay the groundwork for building a submission-ready 
manuscript like specialist nurses or physician assistants do 
for physicians treating patients.
 For early-career PMWs, working on research manuscript 
projects can be a daunting challenge. In this guide, I share 
my perspective on the role of PMWs in such projects, our key 

functions and responsibilities, and tactics and tips that have 
helped me excel at these projects.

HOW MEDICAL WRITERS CONTRIBUTE TO 
RESEARCH MANUSCRIPT PROJECTS
In collaboration with the lead clinical investigators/authors 
and under their guidance, PMWs can contribute to various 
aspects of manuscript preparation (Figure 2, next page). As 
a freelance PMW, I have sometimes been asked to prepare 
only a partial or complete first draft. Other times, I have sup-
ported research manuscript projects from conception and 
through various revisions, until readiness for journal sub-
mission. Occasionally, I have been tasked with revising the 
work of others for submission to a different journal.
 The work of PMWs on research manuscript projects must 
reflect guidance provided by professional ethics,5-8 standards 
for best practice,9-13 applicable health research reporting 
guidelines,14 and journal-specific instructions for authors 
(Figure 3, next page). In light of this guidance, my main goal 
as a PMW is to produce a succinct, clear, well-organized, and 
accurate draft document that reports the results of a study 
and the authors’ interpretation while adhering to the guide-
lines for the target journal. By producing a high-quality, 
data-supported work, I maximize the chances that the  

Figure 1. Types of biomedical research manuscripts.

Research 
manuscripts

Preclinical 
studies

Clinical 
trials

Case-control 
studies

Cohort 
studies

Systematic 
literature 

reviews and 
Meta-analysesCase 

seriesCase 
reports 

Epidemiological 
studies

Surveys

Cost-
effectiveness 

analyses

Genetic and 
genomic 
studies

Healthcare 
outcomes 
research

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AMWAJournal.org     14Working on Clinical Research Manuscripts for Peer-Reviewed Medical Journals

manuscript will be accepted for publication and minimize 
the work required of others (eg, authors, editors, other col-
laborators, colleagues).
 As a PMW of a research manuscript, I am usually not 
considered an author because my contributions do not 
meet all 4 of the International Committee of Medical 
Journal Editors (ICMJE) criteria for authorship (Figure 4).9 
Per ICMJE standards, journal guidelines, and other best 
practices, manuscripts must acknowledge the contribu-
tions of PMWs and medical editors along with the source  
of funding for their work.

Clinical 
trial results

Protocol

Interim or final 
analysis of data 
compiled in:
•Tabulated data 

(eg, TLF, 
spreadsheets)

•CSR or other 
study report

•Partial analysis
•Oral or poster 

presentation

Manuscript 
conception

Meetings and 
communications 
with authors, 
biostatistician, 
PMW, other team 
members to 
discuss:
•Main objectives 

of publication
•Key data, 

figures, tables
•Target journal
•Authorship
•Timeline

First draft 
(detailed outline 
or manuscript)

Literature 
research

Edit, write, 
reference, 
annotate

Data-check and 
fact-check

Format per 
journal 
requirements

Query regarding 
missing data and 
other issues

Revise and 
finalize 
draft

Track 
versions

Compile 
comments

Incorporate 
author edits and 
comments

Query regarding 
unclear comments

Edit and format

Prepare for submission 
to target journal

Journal 
submission 
and review

Editorial 
review

Peer 
review

Decision

Journal 
decision

Accept with no 
caveats

Reject

Revise in response 
to reviewers' 
comments with 
conditional 
acceptance or 
option to resubmit

Professional medical writer (PMW)   

Authors

Figure 2. How a PMW might contribute to the preparation of a clinical trial research report for submission to a peer-reviewed journal.

Ethics

AMWA

EMWA

ISMPP

Standards 
for best 
practice

ICMJE

GPP

CSE

Health 
research 
reporting 
guidelines

EQUATOR network
• CONSORT 

(randomized 
trials)

• STROBE 
(observational 
studies)

• PRISMA 
(systematic 
reviews)

• SQUIRE (quality 
improvement 
studies)

• Many more

Journal-
specific 

instructions 
for authors

Editorial 
policies

Guidance for 
specific types 

of articles

Manuscript 
preparation 

and submission 
requirements

Figure 3. Key sources of guidance 
for PMWs working on research 
manuscripts. AMWA, American 
Medical Writers Association; 
CSE, Council of Science Editors; 
EMWA, European Medical Writers 
Association; GPP, Good Publication 
Practice; ICMJE, International  
Committee of Medical Journal 
Editors; ISMPP, International 
Society for Medical Publication 
Professionals; PMW, professional 
medical writer.

Figure 4. How ICMJE authorship criteria usually apply to PMWs working on research manuscripts. 

Substantial contribution to work

Conception or design
Data acquisition, 
analysis or 
interpretation

Content of work

Draft work or 
critically revise it for 
important 
intellectual content

Approval of work

Approval of final 
version for 
publication

Accountability for work

Agree to be 
accountable for all 
aspects of work to 
ensure appropriate 
investigation and 
resolution of any 
accuracy or integrity 
questions

Author

PMW

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AMWAJournal.org     15Working on Clinical Research Manuscripts for Peer-Reviewed Medical Journals

ESSENTIAL SKILLS AND COMPETENCIES FOR 
WORKING ON RESEARCH MANUSCRIPTS
PMWs must have a variety of skills and high-level 
competencies (Figure 5). It is not a hobby that can 
be casually picked up—it’s a profession. For exam-
ple, being considered a good writer as an under-
graduate, earning a doctorate in a life science field, 
doing postdoctoral research, and being an author 
of several nonclinical research manuscripts did 
not automatically make me a good medical writer. 
I was fortunate to be hired as an entry-level medi-
cal writer at a medical communication company. 
While there, I developed my medical writing and 
editing skills through AMWA workshops and sem-
inars, diligent practice, reading good medical 
writing, and receiving constructive criticism and 
feedback from medical editors and other experi-
enced colleagues. When I started my own freelance 
business, I continued to expand these skills by 
always striving to improve.

Interpersonal skills
• Communications and tact
• Team player
• Attention to detail
• Time management
• Organization
• Logical and analytical thinking
• Problem-solving and creativity

Writing and editing skills 
• Grammar and usage
• Sentence structure
• Spelling
• Punctuation
• Planning and outlining

Medical writing knowledge 
and skills
• Manuscript construction
• Medical terminology and 

concepts
• Data and statistics
• Literature research
• AMA Manual of Style
• Journal requirements
• Annotation
• Art of query

Software skills
• Word processing
• Create and manipulate tables 

and graphs
• Online research
• Reference management

Professional ethics and best 
practices
• Familiarity and applicability
• Understand responsibilities
• Make good decisions

Table 1. Selected Recommendations for Good Medical Writing of Research Manuscripts Reporting Clinical Trial Results

Topic
Applicable Statements From AMA Manual of Style 
11th Edition My Recommendations

Active Voice 
Versus 
Passive 
Voice 

“In general, authors should use the active voice, except 
in instances in which the actor is unknown or the interest 
focuses on what is acted on …”1,a

“If the actor is mentioned in the sentence, the active 
voice is preferred over the passive voice.”1,a

Use a judicious mixture of active voice and passive voice.
Active voice makes the writing clearer and more concise. It also 
emphasizes the authors’ ownership of their work.
Too much passive voice makes the writing boring and verbose,  
causing the reader to lose interest.

Patient or 
Participant 
Instead of  
Subject or 
Case

“Some consider subject (as in study subject) to be im-
personal, even derogatory, as if the person in the study 
were in a subservient role. Similarly, the use of case is 
dehumanizing when referring to a specific person.”1,b

Use the term patient if the study participant is being treated for a 
medical condition.
Use the term participant or volunteer if the study participant is 
healthy and/or is not being treated.
Keep in mind that the study participants or their loved ones might 
read the publication. We must show respect for their personhood 
and contributions.

Sex and 
Gender

Use sex-neutral terms when applicable. For example:1,c

• Chair or chairperson instead of chairman or chairwoman
• Layperson instead of layman
• Humankind instead of mankind

“When reporting the sex of participants in a table, in-
clude both sexes, as identified in the study, regardless of 
the ratio. Do not use “white” and “male” as the default.”1,d

Report data on sex and gender in an equitable, inclusive, and consis-
tent manner. Don’t report only the data for the majority group.
When sex/gender is irrelevant, reword the sentence to use they as 
singular or plural.
This is an evolving area; read on the topic,15,16 attend an AMWA talk 
about it, and research the latest trends.

Race and 
Ethnicity

“… be sensitive to the designations that individuals 
or groups prefer. Be aware also that preferences may 
change and that individuals within a group may disagree 
about the most appropriate designation.”1,e

Report data on race and ethnicity in an equitable, inclusive, and  
consistent manner. Don’t report only the data for the majority  
group. Be as specific as possible when reporting data by race and 
ethnicity (eg, include definition of “other” category).

Terms for 
People With 
Conditions, 
Disorders, 
or Diseases

“Avoid labeling (and thus equating) people with their 
disabilities, or diseases (eg, the blind, schizophrenics, 
epileptics). Instead, put the person first.”1,f

“Avoid describing persons as victims or with other  
emotional terms that suggest helplessness.”1,f

Some of my preferred phrasing:
• Patient with cancer instead of cancer patient or cancer victim
• People with obesity instead of the obese
• Persons (or people) with COVID-19 instead of COVID-19 patients

(or cases)
• Older patients (or patients ≥ 65 years of age) instead of the elderly

aPage 431, bpage 513, cpages 543-544, dpage 544, epage 546, fpage 547.

 Mastering the craft of medical writing is key to successfully com-
pleting a research manuscript project. The AMA Manual of Style1 is an 
important resource for PMWs who work on manuscripts for submission 
to American medical journals. Most of these journals base their style and 
format on the AMA Manual. When I work on a manuscript for submis-
sion to a peer-reviewed journal, I apply the AMA Manual guidance (for 
examples, see Table 1) along with guidance provided by the journal’s 

Figure 5. Essential knowledge and skills for medical writers working on research 
manuscript projects.

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AMWAJournal.org     16Working on Clinical Research Manuscripts for Peer-Reviewed Medical Journals

manuscript preparation instructions. Doing so improves the 
consistency and clarity of my work and helps me educate 
other collaborators (eg, authors, clients, colleagues) on best 
practices in medical writing.

HOW TO GET STARTED ON A CLINICAL RESEARCH 
MANUSCRIPT PROJECT
As I work on these manuscripts, I am especially cognizant of 
the second principle from the AMWA code of ethics, which 
states that “Medical communicators should apply objectiv-
ity, scientific accuracy and rigor, and fair balance while con-
veying pertinent information in all media.”5 As PMWs, we 
must keep this principle at the forefront when we synthesize 
information and data from various sources (Figure 6) to pro-
duce cogent and accurate drafts for authors to develop.
 Once I receive a research manuscript assignment, I take 
several steps to ensure that I start the project efficiently 
(Table 2). First, I review and organize the provided assign-
ment document(s), background information, and other 
materials. As a freelancer who is usually not bound to a 
company’s internal processes, I have developed my own 

system of 5 main electronic folders (named Background, 
Communications, Paperwork, References, Text), each 
labeled with a client and project code. I make sure that I 
understand the project specifications, the team’s roles and 

Figure 6. Examples of information and data sources for the major 
sections of a clinical research manuscript. Notes from authors can 
come from meetings, emails, and phone calls. CSR, clinical study 
report; TLF, Tables, Listings, and Figures.

• Text and notes from authors
• Outline (simple or detailed)
• Protocol
• CSR or other study report
• Provided references and research

• Text and notes from authors
• Protocol
• Statistical analysis plan
• CSR or other study report

• Text and notes from authors
• CSR or other study report
• TLF or other tables and figures
• Slides and poster presentations
• Excel files of data, figures, tables

Introduction and 
Discussion

Methods

Results

Examples of Sources Major Sections

Table 2. Key Steps and Tips for Starting a Manuscript Project for Submission to a Medical Journal

Step Tips
1. Study and organize materials, 

and keep them organized.  
• Organize project materials into standardized electronic folders.
• Keep emails and notes of kick-off and follow-up phone conversations and live/online meetings (start 

and maintain a paper trail to document everything).

2. Determine what else is needed, 
keep notes on the project, and 
proactively communicate issues.

• Take notes regarding project-related questions and issues that arise.
 If issues can’t be resolved by digging deeper in material, send queries via emails to a key contact.
 Keep track of queries and responses (eg, save emails in project subfolder).

3. Review author manuscript 
preparation instructions for 
target journal.

• Find examples of recent articles from journal.
• Take notes on requirements and stylistic preferences:
 Word counts for abstract and main text.
 Limits for numbers of tables, figures, and references.
 Types of headings.
 Data format (eg, P values, significant digits).

4. Set up Word manuscript file. • Follow the author manuscript guidelines for the target journal.
• Modify the heading styles to outline and organize your draft.
• Include a statement acknowledging contributions as a medical writer/editor and the source of funding 

for this work.
• Use the Quick Access toolbar, keyboard shortcuts, Navigation Pane, and split screen option (View 

panel) to work efficiently.

5. Set up reference management 
library (eg, EndNote).

• Import citations from PubMed, other databases, and journal websites.
• If needed, correct EndNote style to match current format used by journal.

6. Use easy and consistent naming 
formats for reference PDFs.

• My preference: First author’s last name, journal abbreviation, year of publication (eg, Smith et al J Clin 
Oncol 2023)

• Don’t name files by their title (it’s too long, and that’s not how papers are cited) but do consider includ-
ing a short phrase summarizing the title (eg, Smith et al J Clin Oncol 2023 [phase 3 drugX melanoma]).

7. Use a file naming system that 
promotes version control

• Name files in a consistent manner (eg, “smith phase2 ms d1.0”).
• Have reviewers add initials when they send in their comments or rename the file yourself when you 

receive it (eg, “smith phase2 ms d1.0_MN”).

PDF, portable document format.

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responsibilities, the format for required deliverable (eg, out-
line, manuscript), and the timeline. When I work with a new 
group, I also need to confirm the lines of communication 
(eg, who will answer queries, who will provide portable  
document format (PDF) files for reference articles).
 Second, I identify what else I need to start the project  
and decide on my next steps (eg, what questions to ask;  
what to research). Typically, the initial questions I need 
answered are:

• What sources of materials (eg, protocol, study report, key
references) do I have to write and/or revise the draft?

• What is the target journal?
• What is the deadline for my first deliverable?
• Does the client want me to highlight sources and

annotate the first draft? If yes, do they require a specific 
format?

• Which, if any, reference management software may
I use?

 Third, I study the journal’s manuscript preparation 
instructions. To help structure and format the manuscript, 
I find 2 or 3 studies published in the target journal that are 
similar to the one that I am working on. I also try to find a 
few recent publications by the lead author(s) to get a gen-
eral idea of their writing style.
 Fourth, I set up the Word document. Unless a client 
requires me to use their template, I structure my Word man-
uscript to comply with the manuscript preparation instruc-
tions. I like to modify the style headings to help me outline 
and navigate the draft.
 Fifth, I set up a reference management library for the 
project. I use EndNote. Other options include Mendeley and 
Zotero. A reference management software program is an 
essential time-saving tool for PMWs to manage references, 
create citations, and generate reference lists that conform to 
the target journal style.
 Sixth, I use a consistent naming format for my reference 
PDFs so that I can easily access the correct reference as I 
develop a draft outline or manuscript. I used to print refer-
ence articles and other key sources, but I no longer do that. 
I work from the PDFs, keeping them side by side with my 
draft and highlighting and annotating as I go.

Seventh, I use a simple file naming system that promotes 
version control to minimize confusion during reviews. Of 
course, sometimes the lead author or client renames files 
using their own system. I stick with what they decide and 
keep detailed notes to keep track of versions and author 
responses.

HOW TO DEVELOP THE FIRST DRAFT OF A 
CLINICAL RESEARCH MANUSCRIPT
Similar to the approach recommended by other PMWs,17 I 
start by drafting the Methods and/or Results, which are the 
most straightforward sections of a typical clinical research 
manuscript (Figure 7). This approach helps me familiarize 
myself with the study and avoid writer’s block. Sometimes, 
perhaps because a section is tedious, I alternate working on 
different sections. Clinical trials tend to have similarly orga-
nized Methods section, unlike in vivo and in vitro exper-
imental studies which have varied methodologies even 
within the same research area.

Figure 7. Sequential approach to building a research manuscript 
reporting clinical trial results.

 After I have drafted the Methods and Results sections, I 
work on the Introduction and sketch out a discussion for the 
authors to modify and expand. The abstract is usually the 
last section I work on because I tend to build it by cutting 
and pasting key sentences from the main sections and then 
editing the text to fit the required word count. Once, a lead 
author asked that I start with the abstract to help him orga-
nize his thoughts at the onset of the manuscript. Luckily, I 
only had to update and edit an abstract that the authors had 
presented at a conference.
 As I research and write the first draft of a detailed out-
line or manuscript, I highlight references and annotate cor-
responding PDFs (Figure 8). In comment boxes or within 
brackets in the text, I include notes and queries regarding 
any potential issues (eg, missing or unclear methods, incon-
sistent use of terms) (Figure 9). I also compile small batches 
of queries that require prompt attention because they impact 
how I proceed in my work and email them. It’s important to 
resolve issues sooner rather than later. I absolutely do not 
want to submit a draft peppered with queries that should 
have already been resolved.

Methods
•Study design
•Trial oversight
•Patient recruitment and 
eligibility criteria

•Objectives/endpoints 
•Assessments
•Statistical analysis

Figures and Tables
•Patient disposition flow 
diagram (CONSORT)

•Baseline characteristics 
table

•Efficacy table(s) and/or 
figure(s)

•Safety table(s)

Results
•Patient disposition
•Patient baseline
characteristics

•Summarize efficacy
•Summarize safety and 
tolerability

Introduction
•Highlights of disease
problem

•Intervention background
•Rationale for trial
•Purpose of trial

Discussion
•Study design and key
results

•Results in context of 
literature and clinical 
practice

•Limitations
•Future directions
•Conclusions

Abstract
•Background
•Methods
•Results
•Conclusions

Track the word count

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AMWAJournal.org     18Working on Clinical Research Manuscripts for Peer-Reviewed Medical Journals

Throughout this work, I keep track of the word count (which 
for some journals can be quite stingy). Before I send any 
draft for review, I make sure to update the word counts for 
both the main text and the abstract. One of the tasks we have 
as PMWs is to help the authors comply with the word count 
requirements. This can be challenging during the draft revi-
sion process. When authors exceed the word count limit, I 
suggest edits in track changes to retain the meaning while 
reducing verbiage. Sometimes, I suggest that they move cer-
tain sections to an online supplement.

HOW TO AVOID COMMON PITFALLS
Common pitfalls of writing research manuscripts include 
accidentally plagiarizing published information and/or 

repurposing unpublished content; perpetuating inaccurate 
content; inserting erroneous data; creating a disorganized, 
inconsistent manuscript structure; and introducing typos, 
spelling mistakes, and poor grammar (Figure 10). Most of 
these errors are unintentional and are caused by taking 
shortcuts. I employ several tactics to avoid these pitfalls. If 
medical editors are on the project team, they will also check 
for these issues, but they might not be involved until later, 
and we should give them and the authors a well-written and 
organized draft to work on.

Cite and Paraphrase Content
Because plagiarism is unethical and infringes on intellectual 
property rights, PMWs should know how to paraphrase  

Figure 8. Examples of reference 
annotation formats.

Figure 9. Tips and examples of in-text and email queries.

Format

Minimal 

First author, 
journal, year, 
page(s), column, 
section

First author, journal, 
year, page(s), 
column, paragraph 
or line number

Example

First author, journal, 
year, page(s)

Detail level

Moderate 

High

Tips

Query 
in text 

Example
• Concise and polite
• Clearly marked to distinguish them 

from Notes or Annotations
• If specific to a person, include 

name in query
• Provide specific suggestions 

whenever possible

Format

Email • Succinct, organized, and polite
• Use bulleted lists
• Identify the relevant section of 

manuscript
• Make it easy to read and reply

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content and properly cite its sources. We should not suc-
cumb to the temptation of copying text from study protocols, 
clinical study reports (CSRs), and other unpublished docu-
ments. The writing style of such documents is often unsuit-
able for a journal article because it may be passive, formulaic, 
and verbose. It’s better to paraphrase the material, pay atten-
tion to active and passive voice, and avoid using archaic 
terms like subject and Caucasian. I am also cautious about 
copying whole or parts of tables across files because disrup-
tive formatting codes might transfer to the manuscript.
 I would not use any content generated by an artificial 
intelligence program like ChatGPT. Several leading journals 
have published editorials discussing this controversial, still 
evolving technology and limiting or prohibiting its use in 
manuscripts submitted for publication.18-21

Verify Data and Facts
Another common pitfall in writing clinical research manu-
scripts is incorporating data and information cited in other 
documents (eg, protocols, CSRs, published articles) without 
factchecking the accuracy of each citation. I check the  
cited reference (often using the PDF search field to quickly 
find specific numbers or terms) to determine if it does 
indeed provide the information. Also, when the cited infor-
mation is older than 1 to 2 years (depending on the field’s 
pace of research), I do literature searches to identify more 
recently published sources. This is especially important  
for rapidly advancing fields like oncology in which, for 
example, the American Cancer Society publishes new  
statistics every year.

 Even when not required by project specifications, I  
highlight references and annotate the detailed outline or first 
draft of a manuscript to keep a record of the sources of any 
included information and data. This documentation step 
does not take long, and it saves time and headache during the 
review/revision process in addressing questions regarding 
data accuracy, conflicting information, and other issues that 
might be raised by authors and other project participants.
 I have noticed, when factchecking others’ work, that 
some writers cite a published research manuscript as the 
source of information referred to in the Introduction or 
Discussion sections of the cited publication. This is a mis-
leading use of a citation. For example, the Introduction sec-
tion of a hypothetical phase 2 study by Smith et al on a new 
adjuvant drug for people with resectable pancreatic cancer 
mentions a range of reported median progression-free  
survival (PFS), citing 3 sources. Instead of taking the short-
cut of inaccurately citing the Smith et al study in my manu-
script, I would cite the primary sources for the PFS data or a 
reputable review. I would cite the Smith et al paper if I were 
discussing the results or conclusions of their study.

Avoid Inserting Numerical Errors
The compilation of data in tables and figures is one of  
most tedious tasks of a research manuscript project. It’s 
challenging to keep track of and accurately copy num-
bers from large tables that were prepared for CSRs, Tables, 
Listings and Figures (TLFs), and other study reports. These 
are the steps I take to avoid losing track as I copy numbers:

• Place documents next to each other on a large screen.

Figure 10. Common pitfalls and how to avoid them.

Manuscript
quality

Plagiarize 
and/or 

repurpose 
content

Perpetuate  
inaccurate 
data and 

facts

Insert 
erroneous 

data

Create a  
disorganized 
inconsistent 

structure

Introduce 
typos and 

other 
mistakes

Prevention:
• Fact-check
• Research

Prevention:
• Paraphrase
• Cite

Prevention: 
• Proofread

Prevention:
• Check for  consistency
• Keep parallel structure

Prevention:
• Carefully copy data
• Perform quality 

control checks

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AMWAJournal.org     20Working on Clinical Research Manuscripts for Peer-Reviewed Medical Journals

• Enlarge source and recipient documents.
• Copy (cut/paste or retype) and round (if necessary) 

small batches of numbers at one time.
• After copying the numbers, highlight the data in the 

source document (to mark my place).
• Every 2 to 3 rows of copied numbers, backtrack and 

double-check the values to correct any typos.

 The data in tables from CSRs, LTFs, and other statistical/
mathematical outputs can be difficult to read because of 
the multiple digits to the right of the decimal (eg, 45.567% 
vs 45.6% or 46%). Often these digits are not scientifically sig-
nificant, especially when they were generated to calculate 
percentages or mean/medians. As noted in the 11th edi-
tion of the AMA Manual of Style1(p1010), “When numbers are 
expressed in scientific and biomedical articles, they should 
reflect the degree of accuracy of the original measurement. 
Numbers obtained from mathematical calculations should 
be rounded to reflect the original degree of precision.” The 
AMA Manual has a helpful section summarizing round-
ing rules.1(p1011) In addition to being scientifically accurate, 
rounded numbers are easier to read. However, before doing 
any rounding, it’s important to verify with the authors how 
many significant digits they would like to use throughout 
their manuscript.

Create an Organized Consistent Manuscript
To create a well-organized and easy to read manuscript, 
PMWs must ensure the consistent use of terms, abbrevia-
tions, and data across the different sections of the manuscript 
(ie, abstract, main text, tables, figures, online materials). For 
example, the definition of an outcome measure described 
in the Methods and Results sections should match the defi-
nition used in a table. For numerical data, inconsistencies 
might especially occur whereby numbers are rounded in 
one section of the manuscript (eg, the Results text) but not in 
another (eg, a table, figure, or abstract). I use the Word Split 
screen option (Window submenu in the View bar) to help 
me verify that numerical data are reported in the same way 
across sections.
 We should also use parallel structure in subheadings, 
paragraphs, and sentences that are discussing similar infor-
mation. For example, the presentation of information in the 
Methods section should match the sequence and content of 
data discussed in the Results section.
 Although some of these tactics may appear subtle, 
together they improve manuscript clarity and maintain 
reader’s interest.

Proofread Your Drafts
As I work on a draft in Word, I turn on the Spelling and 

Grammar checker under the Proofing submenu of the 
Review tab. Despite this and careful writing, errors slip 
through. Thus, even if other people will review my work, I 
proofread it before sending any draft to the next step in the 
process. The point of proofreading is to catch and correct any 
mechanical errors, not to second-guess myself and rewrite.
 It’s challenging to proofread your own work because 
when you are immersed in writing a draft, your eyes tend to 
skim over words they have seen repeatedly, allowing errors 
to become invisible. To reset and refresh my eyes and brain 
after I finish a draft, I wait for several hours or, preferably, 
until the next morning before proofreading it.
 I proofread on screen, zooming in to enlarge text 15% to 
25% of my normal writing mode. Early in my writing career, 
I proofread printed drafts. I switched to working onscreen 
years ago because it works well for me and reduces paper 
waste. Other tips for proofreading onscreen include chang-
ing the background color, reading text aloud, and point-
ing at words as you read them. An interesting tactic Hope 
Lafferty, ELS, spoke about during her excellent AMWA 2022 
Annual Conference education session entitled “Editing Your 
Own Work (After You’ve Read it 1,000 Times)” is to read text 
backwards, word by word or sentence by sentence.

TIPS FOR WORKING WITH CHALLENGING 
PERSONALITIES
Some authors and clients are easy to work with in a collabo-
rative manner. Others might pose challenges. For example, 
they could be unresponsive, set in their ways, condescend-
ing, overly demanding, and inexperienced. Regardless, as 
PMWs we have to remember that the authors have the final 
say and responsibility for the content of their manuscript. 
We can offer suggestions and provide education, but all final 
decisions are theirs.
 Patience and tact are essential for working with chal-
lenging individuals. For example, when I must respond to 
an irritating email, I draft a response and then step away 
from it for at least several hours before editing (usually to 
tone it down) and clicking send. Sometimes it might help to 
discuss the matter with a trusted colleague before further 
communicating with the difficult person.
 During a project, I routinely keep all my emails in an 
organized fashion so that I can verify prior responses (keep-
ing that paper trail documentation mentioned earlier). This 
is especially helpful when someone tells me to do one thing 
one week and something completely different a week later, 
doesn’t respond to several polite emails asking for clarifica-
tion or further instructions, or demands their draft earlier 
than agreed.
 Other tactics for working with different personalities 
include:

http://www.amwajournal.org


AMWAJournal.org     21Working on Clinical Research Manuscripts for Peer-Reviewed Medical Journals

• Be clear, concise, and tactful in all forms of communi-
cation (ie, email, queries in the drafts, voicemail).

• Suggest concrete solutions for issues regarding their 
writing—for example, instead of saying that text is 
unclear, I reword it into what I think it means and ask 
the authors if my edited version is correct.

• Use information from the AMA Manual of Style, 
journal author guidelines, and examples from arti-
cles published in the same journal or in more presti-
gious journals to educate about formatting and style 
decisions you implemented in a manuscript—for 
example, sometimes authors spend their valuable 
manuscript-review time to change “ie or eg” to “i.e. or 
e.g.” They don’t understand that I purposely used the 
unpunctuated abbreviations to follow the journal style 
(even though I noted on the first page that the man-
uscript is formatted per a specific journal). In these 
cases, I don’t accept the author changes and explain 
my rationale, citing the appropriate style manual or 
manuscript preparation instructions.

• Try alternative ways of communication—some people 
who don’t respond to emails might be reachable 
through a phone call or by first speaking with their 
administrative assistant or another member of the 
project team. Online meetings to share the screen and 
do edits live might work well for authors who never 
find the time to review drafts and send their com-
ments via track changes.

FINAL WORDS
Being a PMW is rewarding and humbling. We should take 
pride in the ways we contribute to the clear and timely pub-
lication of research findings. It is gratifying to hear from 
authors how much they appreciate our work. However, we 
also have to accept feedback and corrections from editors, 
authors, and other stakeholders involved in the project. 
When we make mistakes, we should take responsibility, apol-
ogize, and learn. These actions help us grow as profession-
als and maintain good working relationships with authors, 
clients, supervisors, and colleagues. Regardless of whether a 
PMW works on research manuscripts or other types of proj-
ects, practice and ongoing learning are critical for success.  
To keep up with progress in our profession and in the ther-
apeutic areas we work on, PMWs must continue to broaden 
our knowledge base and skill sets throughout our careers.

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

Author contact: monica@nicosiamedicalwriter.com

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https://www.equator-network.org/



