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MANUAL OF
NARRATIVE WRITING

CONTENTS
INTRODUCTION
BASIC TERMINOLOGY
NARRATIVE WRITING PRINCIPLES
RULES OF NARRATIVE WRITING
CHECKING A WRITTEN NARRATIVE
WRITING PROCESS FLOW CHART
GLOSSARY

MANUAL OF NARRATIVE WRITING

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INTRODUCTION
The idea of this manual is to introduce the newcomers to the basic writing
principles. This is based on the initial writing experiences of other newcomers
and the initial difficulties faced by them. Any further clarification/doubts must be
addressed to your Project Manager.

BASIC TERMINOLOGY
Some of the basic terms a medical writer comes across are explained below.
Clinical Trial: These are the trials companies do to test the efficacy of their drug
as well as to look for adverse effects before getting approval for launch in the
open market. There are several phases (Phase 1 to 4) in which they are
conducted. More details can be looked at appropriate places.
Source Files or CRF: Whenever a trial goes on, the records of a particular
subject are compiled together on a day to day basis throughout the trial and
these are called source files or CRF (case report file). It is from these source files
(called appropriately so) information is extracted while writing a narrative.
CIOMS: This is the Council for International Organizations of Medical Sciences,
was formed in 1949 by WHO and UNESCO. CIOMS form is the standard
reporting format of serious adverse events while conducting clinical trials
worldwide to respective regulatory authorities.
SOP: This is Standard Operating Protocol. Once finalized, this is the gold
standard to be stuck to, in letter and in spirit, while writing a narrative. It defines
exactly how the narrative will be written.
Narratives: Narratives are synopsis of a particular subject who has been
involved in a clinical trial. It may be of any phase and anywhere in the world. If a
source file is very well documented almost all the information needed for writing a
narrative can be found here. In case there is something missing CIOMS report is
also a narrative in itself and can give good amount of information.

MANUAL OF NARRATIVE WRITING

NARRATIVE WRITING PRINCIPLES

This section explains how to frame the complete narrative.
Writing Style: This is determined by the choice of the client but there exists a
certain format in which all narratives. Please have a close look at the following
sequence of statements that are followed in a narrative.
Narrative Outline: A narrative is written with these sentences coming one after
another in the following order. Please give special attention to the order of these
sentences.
1) Subject ID (most serious adverse event/events):
2) This age-year-old ethnicity man/woman had a medical history of XXXXX.
Including past history and history at the time of the start of the trial
3) Upon study admission, the subject was noted to have XXXXX. The reason
he/she is being treated with the study drug.
a. He/She was randomly assigned to treatment with XXXXX. Study
drug and dosing regimen,
4) A description of the most serious adverse event (e.g. prolonged
hospitalization or death) including the day it started, its effect and the
action taken (e.g. withdrawal of treatment or change in dosing regimen) if
any.
5) A description of the nature (intensity) and relationship of this event to the
study medication, e.g., not related/possibly related/related to the study
medication. (causality information)
6) The treatment used for this event and the outcome (resolved, persisted,
etc.) If death was the most serious event, this sentence is not necessary
7) Other adverse events are listed and relation of these adverse events and
their outcomes are given too.
8) List and description of laboratory results/vital signs which are related to
the serious adverse event/events and their outcome and/or a statement
stating that no significant lab values/vital signs were reported.
9) The last sentence as statement, The subject completed the study on
Day X or The study was terminated on Day X due to XXXXX.
MANUAL OF NARRATIVE WRITING

Now look at the following narrative and note all these ten sentences forming the
complete body of narrative. The sentence number is superscripted in red color
after it has been placed in box parenthesis.
[Subject ### (infection of both wrists after suicide attempt, left wrist
cellulitis, and suicide attempt)]1: [This 21-year-old Caucasian woman had a
history of alcohol use, amphetamine use, heroine use, depression, mitral valve
thickening, and right eye blindness.]2 [Upon study admission, the subject was
noted to have abscess that was positive for Staphylococcus aureus.]3 [She was
randomly assigned to treatment with ceftobiprole, 500 mg twice daily
administered intravenously over 60 minutes.]4 [The subject experienced serious
adverse events, infection of both wrists after suicide attempt (Day 27) and left
wrist cellulitis (Day 31).]5 [All the serious adverse events were life threatening
and considered unrelated to study medication.]6 [The subject was treated with
psychiatric counseling and pip/tazo, and the events resolved without sequelae.]7
[Other adverse events reported during the study were mild butterscotch aftertaste
(Day 1), which was considered possibly related to study medication, and mild
left arm paresthesia (Day 31), which was considered unrelated to study
medication. Both events resolved without sequelae.]8 [No clinically significant
changes in laboratory values, vital signs, or physical examination results were
reported during the study.]9 [The subject completed the study on Day 42.]10
Following is the list of sections of source file where a newcomer can look for
information again following the same order of sentences.
1.
2.
3.
4.

Demographic Profile and Adverse Events

Medical History
Medical History and CIOMS Report
Dosing section, CIOMS and SOP (this statement is generally decided as it
is a standard statement to be used in all narratives
5. Adverse Events and CIOMS
6. Causality Column of Adverse Event Section
7. ConMed Section
8. Adverse Event Section
9. Laboratory Section and Vital Sign Section
10. Study Comments Section. Read its different columns carefully for
complete information.

MANUAL OF NARRATIVE WRITING

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Guidelines for Writing a Narrative:
1. The Header: This is the first line and written in bold. It includes subject XX
and then the,
Adverse event which led to death, or
Adverse event which led to discontinuation of study, or
The serious adverse event.
If there are more than one serious adverse event, all should be included.
2. Medical History and ConMeds: Only the medical history which is
relevant in terms of the SAE should be considered. Same is the case of
concomitant medications. Needless elaboration should be avoided.
3. Study Drug: The drug, dose and duration to be mentioned in a statement.
4. Serious Adverse Event: This is the soul of a narrative and the term to be
used is the MedDRA (or WHOART) preferred one but investigators term
may be used to clarify further in parenthesis. Following information about
SAE should always be provided,
Timing of SAE
Diagnostic Procedure if any
Nature and Intensity
Causality Information according to the investigator
Action taken for the SAE, like, stopping the drug, etc.
Outcome of SAE
5. Other Adverse Events: Only those AEs which are related to the SAE
should be mentioned. Same information should be provided for AEs as for
SAE.
6. Laboratory findings and Vital signs: Once again only those which are
related to the SAE should be taken into account.
7. CIOMS: Whenever information comes from CIOMS report, CIOMS should
be mentioned in parenthesis at the end of information. Mention the
complete CIOMS report number at the end.

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Organizing Written Narratives:
Narratives are organized in batches. They are divided according to
1. Study group and then
2. According to their number.
They are further sub categorized according to,
1. Death
2. SAE
3. AE leading to discontinuation
If there is a subject who falls in more than one of the three categories, a
single narrative is provided for him/her and the order to be followed is the
same as above, i.e., death, SAE and AE leading to discontinuation.
Sometimes the client will want multiple narratives for the same subject. In
this case the major narrative is the one involving the most serious
category. Then there could be minor narratives for the less serious
categories. DEATH might be the major and SAE and DC would be minor
narratives.

MANUAL OF NARRATIVE WRITING

RULES OF NARRATIVE WRITING

1. Style: The writing style of all narratives of a clinical trial must be similar.
2. Grammar: This must be impeccable. There is absolutely no scope of wrong
English as this defeats the whole purpose of good writing.
3. Spellings: It may be noted that generally there are two types of Spellings and
they are American and English. Narratives are as a rule written according to
clients wishes and it will depend where the company is based. Confirm the
spelling style from SOP.
4. Spacing: There is always one space between words and either one (English
style) or two (American Style) after a period. Confirm from SOP what the client
wants.
5. Hard Spaces (hard hyphens also):
How to put: This is placed by ctrl+shift+space.
The concept of hard Space: Its concept has to be understood and
then only its importance can be realized. A normal space can split
two words connected by it in two lines when it is opened in
computer; but a hard space, which looks exactly like a normal
space, keeps these two words connected in whatever format or
program that document is opened. Thus it serves a very important
purpose.
Where to apply: It should be applied at following spaces,
1. Between Day and its number
2. Between a Lab test and its value
3. Between the subject and its ID no.
4. Anywhere else where we want to connect two words/values
inseparably.
6. CIOMS: Whenever some information is directly taken from CIOMS report,
place CIOMS in parenthesis after that.

MANUAL OF NARRATIVE WRITING

CHECKING A WRITTEN NARRATIVE

This is required when ones own narrative is checked or if one is asked to QC
(Quality Check) someone elses narrative. One can form any order but a simple
outline is given below,
1. Check if the language and style of narrative is SOP compliant.
2. Check the spellings and grammar. For this Word is not very useful as it
doesnt know most of the medical terms. This has to be done manually.
Check what the client wants, i.e., whether English or American spellings
and period pattern. Proper use of comma, period, colon, semi-colon and
dash is a must.
3. Check for accuracy of content from source file or CIOMS report and also if
all the information as per SOP is given.
4. Check specially for small dash (or minus sign) which is automatically
converted to a big Dash when we type, i.e.; when we type, e.g., Day
space dash X space the dash will become big Dash. Convert it to small
Dash or minus sign as the case may be.(Client specific requirements for
Dash, Hyphen, Hard hyphen, Em dash, or En dash)
5. Finally Check for Spaces. Turn the space button (denoted by space or
music notation sign, just left to your zoom button on the MS-Word Toolbar)
on and look at the text. All normal spaces are shown by a Dot while all
hard spaces will be shown by a Small Circle. Now correct them as
advised earlier. Check the sample narrative given above by clicking space
button to understand this.

MANUAL OF NARRATIVE WRITING

WRITING PROCESS FLOW CHART

THE CLIENT APPROVES A
PROJECT

ALL THE FILES CONTAINING THE

RELEVANT DATA COLLECTED

PROJECT MANAGER DECIDES

THE ROLES OF THE WRITERS AND
DISTRIBUTES BATCHES FOR
WRITING IN THE TEAM

WRITER 1
WRITES
HIS/HER BATCH

BATCHES ARE JUGGLED BETWEEN

WRITERS FOR QUALITY CHECKING

WRITER 2
WRITES
HIS/HER BATCH

MORE EXPERINECED WRITER QUALITY

ANALYSES THE WORK AND MAY KICK BACK TO
ORIGINAL WRITER FOR NECESSARY
CHANGES WITH COMMENTS

QUALITY ANALYSED BATCHES ARE FINALLY

CHECKED BY PROJECT MANAGER AND
UPLOADED IN THE E-ROOM FOR CLIENT
REVIEW AND APPROVAL

MANUAL OF NARRATIVE WRITING

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GLOSSARY
This is a list of very commonly used terms.
AE Adverse Event
CIOMS Form/Report Serious Adverse Event reporting form
ConMed Concomitant Medication
CRF Case Report File
EOT End of Treatment
QA Quality Analyze
QC Quality Check
ReQC Repeat Quality Check
SAE Serious Adverse Event
SOP Standard Operating Protocol
TOC Test of cure

MANUAL OF NARRATIVE WRITING