MANUAL OF

NARRATIVE WRITING
CONTENTS PAGE
INTRODUCTION 2
BASIC TERMINOLOGY 2
NARRATIVE WRITING PRINCIPLES 3
RULES OF NARRATIVE WRITING 7
CHECKING A WRITTEN NARRATIVE 8
WRITING PROCESS FLOW CHART 9
GLOSSARY 10
MANUAL OF NARRATIVE WRITING
1
INTRODUCTION
The idea of this manual is to introduce the necomers to the !asic ritin"
#rinci#les$ This is !ased on the initial ritin" e%#eriences of other necomers
and the initial difficulties faced !& them$ An& further clarification'dou!ts must !e
addressed to &our (ro)ect Mana"er$
BASIC TERMINOLOGY
*ome of the !asic terms a medical riter comes across are e%#lained !elo$
Cl!"#l T$#l% These are the trials com#anies do to test the efficac& of their dru"
as ell as to loo+ for ad,erse effects !efore "ettin" a##ro,al for launch in the
o#en mar+et$ There are se,eral #hases -(hase 1 to ./ in hich the& are
conducted$ More details can !e loo+ed at a##ro#riate #laces$
S&'$"( Fl() &$ CRF% Whene,er a trial "oes on0 the records of a #articular
su!)ect are com#iled to"ether on a da& to da& !asis throu"hout the trial and
these are called source files or 1RF -case re#ort file/$ It is from these source files
-called a##ro#riatel& so/ information is e%tracted hile ritin" a narrati,e$
CIOMS% This is the 21ouncil for International Or"ani3ations of Medical *ciences40
as formed in 15.5 !& W6O and UNE*1O$ 1IOM* form is the standard
re#ortin" format of serious ad,erse e,ents hile conductin" clinical trials
orldide to res#ecti,e re"ulator& authorities$
SOP% This is *tandard O#eratin" (rotocol$ Once finali3ed0 this is the "old
standard to !e stuc+ to0 in letter and in s#irit0 hile ritin" a narrati,e$ It defines
e%actl& ho the narrati,e ill !e ritten$
N#$$#*+()% Narrati,es are s&no#sis of a #articular su!)ect ho has !een
in,ol,ed in a clinical trial$ It ma& !e of an& #hase and an&here in the orld$ If a
source file is ,er& ell documented almost all the information needed for ritin" a
narrati,e can !e found here$ In case there is somethin" missin" 1IOM* re#ort is
also a narrati,e in itself and can "i,e "ood amount of information$
MANUAL OF NARRATIVE WRITING
7
NARRATIVE WRITING PRINCIPLES
This section e%#lains ho to frame the com#lete narrati,e$
W$*!, S*-l(% This is determined !& the choice of the client !ut there e%ists a
certain format in hich all narrati,es$ (lease ha,e a close loo+ at the folloin"
se8uence of statements that are folloed in a narrati,e$
N#$$#*+( O'*l!(% A narrati,e is ritten ith these sentences comin" one after
another in the folloin" order$ (lease "i,e s#ecial attention to the order of these
sentences$
1/ *u!)ect I9 -most serious ad,erse e,ent'e,ents/:
7/ This a"e;&ear;old ethnicit& man'oman had a medical histor& of <<<<<$
Includin" #ast histor& and histor& at the time of the start of the trial
=/ U#on stud& admission0 the su!)ect as noted to ha,e <<<<<$ The reason
he'she is !ein" treated ith the stud& dru"$
./ 6e'*he as randoml& assi"ned to treatment ith <<<<<$ *tud& dru" and
dosin" re"imen0
>/ A descri#tion of the most serious ad,erse e,ent -e$"$ #rolon"ed
hos#itali3ation or death/ includin" the da& it started0 its effect and the
action ta+en -e$"$ ithdraal of treatment or chan"e in dosin" re"imen/ if
an&$
?/ A descri#tion of the nature -intensit&/ and relationshi# of this e,ent to the
stud& medication0 e$"$0 not related'#ossi!l& related'related to the stud&
medication$ -causalit& information/
@/ The treatment used for this e,ent and the outcome -resol,ed0 #ersisted0
etc$/ If death as the most serious e,ent0 this sentence is not necessar&
A/ Other ad,erse e,ents are listed and relation of these ad,erse e,ents and
their outcomes are "i,en too$
5/ List and descri#tion of la!orator& results',ital si"ns hich are related to
the serious ad,erse e,ent'e,ents and their outcome and'or a statement
statin" that no si"nificant la! ,alues',ital si"ns ere re#orted$
1B/The last sentence as statement0 2The su!)ect com#leted the stud& on
9a& < or The stud& as terminated on 9a& < due to <<<<<4$
MANUAL OF NARRATIVE WRITING
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No loo+ at the folloin" narrati,e and note all these ten sentences formin" the
com#lete !od& of narrati,e$ The sentence num!er is su#erscri#ted in red color
after it has !een #laced in !o% #arenthesis$
[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
[!pon study admission, the sub"ect was
noted to have abscess that was positive for Staphylococcus aureus.
#
[$he was
randomly assigned to treatment with ceftobiprole, %&& mg twice daily
administered intravenously over '& minutes.
(
[The sub"ect e)perienced serious
adverse events, infection of both wrists after suicide attempt *+ay 2,- and left
wrist cellulitis *+ay #1-.
%
[.ll the serious adverse events were life threatening
and considered unrelated to study medication.
'
[The sub"ect was treated with
psychiatric counseling and pip/ta0o, and the events resolved without se1uelae.
,

[2ther adverse events reported during the study were mild butterscotch aftertaste
*+ay 1-, which was considered possibly related to study medication, and mild
left arm paresthesia *+ay #1-, which was considered unrelated to study
medication. 3oth events resolved without se1uelae.
4
[5o clinically significant
changes in laboratory values, vital signs, or physical e)amination results were
reported during the study.
6
[The sub"ect completed the study on +ay (2.
1&

Folloin" is the list of sections of source file here a necomer can loo+ for
information a"ain folloin" the same order of sentences$
1$ 9emo"ra#hic (rofile and Ad,erse E,ents
7$ Medical 6istor&
=$ Medical 6istor& and 1IOM* Re#ort
.$ 9osin" section0 1IOM* and *O( -this statement is "enerall& decided as it
is a standard statement to !e used in all narrati,es
>$ Ad,erse E,ents and 1IOM*
?$ 1ausalit& 1olumn of Ad,erse E,ent *ection
@$ 1onMed *ection
A$ Ad,erse E,ent *ection
5$ La!orator& *ection and Vital *i"n *ection
1B$ *tud& 1omments *ection$ Read its different columns carefull& for
com#lete information$
MANUAL OF NARRATIVE WRITING
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G'.(l!() /&$ W$*!, # N#$$#*+(%
10 T1( H(#.($% This is the first line and ritten in !old$ It includes su!)ect <<
and then the0
Ad,erse e,ent hich led to death0 or
Ad,erse e,ent hich led to discontinuation of stud&0 or
The serious ad,erse e,ent$
If there are more than one serious ad,erse e,ent0 all should !e included$
20 M(."#l H)*&$- #!. C&!M(.)% Onl& the medical histor& hich is
rele,ant in terms of the *AE should !e considered$ *ame is the case of
concomitant medications$ Needless ela!oration should !e a,oided$
30 S*'.- D$',% The dru"0 dose and duration to !e mentioned in a statement$
20 S($&') A.+($)( E+(!*% This is the soul of a narrati,e and the term to !e
used is the Med9RA -or W6OART/ #referred one !ut in,esti"atorCs term
ma& !e used to clarif& further in #arenthesis$ Folloin" information a!out
*AE should ala&s !e #ro,ided0
Timin" of *AE
9ia"nostic (rocedure if an&
Nature and Intensit&
1ausalit& Information accordin" to the in,esti"ator
Action ta+en for the *AE0 li+e0 sto##in" the dru"0 etc$
Outcome of *AE
30 O*1($ A.+($)( E+(!*)% Onl& those AEs hich are related to the *AE
should !e mentioned$ *ame information should !e #ro,ided for AEs as for
*AE$
40 L#5&$#*&$- /!.!,) #!. V*#l ),!)% Once a"ain onl& those hich are
related to the *AE should !e ta+en into account$
70 CIOMS% Whene,er information comes from 1IOM* re#ort0 1IOM* should
!e mentioned in #arenthesis at the end of information$ Mention the
com#lete 1IOM* re#ort num!er at the end$
MANUAL OF NARRATIVE WRITING
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O$,#!6!, W$**(! N#$$#*+()%
Narrati,es are or"ani3ed in !atches$ The& are di,ided accordin" to
1. *tud& "rou# and then
2. Accordin" to their num!er$
The& are further su! cate"ori3ed accordin" to0
1$ 9eath
7$ *AE
=$ AE leadin" to discontinuation
If there is a su!)ect ho falls in more than one of the three cate"ories0 a
sin"le narrati,e is #ro,ided for him'her and the order to !e folloed is the
same as a!o,e0 i$e$0 death0 *AE and AE leadin" to discontinuation$
*ometimes the client ill ant multi#le narrati,es for the same su!)ect$ In
this case the ma)or narrati,e is the one in,ol,in" the most serious
cate"or&$ Then there could !e minor narrati,es for the less serious
cate"ories$ 9EAT6 mi"ht !e the ma)or and *AE and 91 ould !e minor
narrati,es$
MANUAL OF NARRATIVE WRITING
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RULES OF NARRATIVE WRITING
10 S*-l(% The ritin" st&le of all narrati,es of a clinical trial must !e similar$
20 G$#77#$% This must !e im#ecca!le$ There is a!solutel& no sco#e of ron"
En"lish as this defeats the hole #ur#ose of "ood ritin"$
30 S8(ll!,)% It ma& !e noted that "enerall& there are to t&#es of *#ellin"s and
the& are American and En"lish$ Narrati,es are as a rule ritten accordin" to
clientsC ishes and it ill de#end here the com#an& is !ased$ 1onfirm the
s#ellin" st&le from *O($
20 S8#"!,% There is ala&s one s#ace !eteen ords and either one -En"lish
st&le/ or to -American *t&le/ after a #eriod$ 1onfirm from *O( hat the client
ants$
30 H#$. S8#"() 91#$. 1-81(!) #l)&:%
H&; *& 8'*% This is #laced !& ctrlDshiftDs#ace$
T1( "&!"(8* &/ 1#$. S8#"(% Its conce#t has to !e understood and
then onl& its im#ortance can !e reali3ed$ A normal s#ace can s#lit
to ords connected !& it in to lines hen it is o#ened in
com#uterE !ut a hard s#ace0 hich loo+s e%actl& li+e a normal
s#ace0 +ee#s these to ords connected in hate,er format or
#ro"ram that document is o#ened$ Thus it ser,es a ,er& im#ortant
#ur#ose$
W1($( *& #88l-% It should !e a##lied at folloin" s#aces0
1$ Feteen 9a& and its num!er
7$ Feteen a La! test and its ,alue
=$ Feteen the su!)ect and its I9 no$
.$ An&here else here e ant to connect to ords',alues
inse#ara!l&$
40 CIOMS% Whene,er some information is directl& ta+en from 1IOM* re#ort0
#lace 1IOM* in #arenthesis after that$
MANUAL OF NARRATIVE WRITING
@
CHECKING A WRITTEN NARRATIVE
This is re8uired hen oneCs on narrati,e is chec+ed or if one is as+ed to G1
-Gualit& 1hec+/ someone elseCs narrati,e$ One can form an& order !ut a sim#le
outline is "i,en !elo0
1$ 1hec+ if the lan"ua"e and st&le of narrati,e is *O( com#liant$
7$ 1hec+ the s#ellin"s and "rammar$ For this Word is not ,er& useful as it
doesnCt +no most of the medical terms$ This has to !e done manuall&$
1hec+ hat the client ants0 i$e$0 hether En"lish or American s#ellin"s
and #eriod #attern$ (ro#er use of comma0 #eriod0 colon0 semi;colon and
dash is a must$
=$ 1hec+ for accurac& of content from source file or 1IOM* re#ort and also if
all the information as #er *O( is "i,en$
.$ 1hec+ s#eciall& for small dash -or minus si"n/ hich is automaticall&
con,erted to a !i" 9ash hen e t&#e0 i$e$E hen e t&#e0 e$"$0 9a&
s#ace dash < s#ace the dash ill !ecome !i" 9ash$ 1on,ert it to small
9ash or minus si"n as the case ma& !e$-1lient s#ecific re8uirements for
9ash0 6&#hen0 6ard h&#hen0 Em dash0 or En dash/
>$ Finall& 1hec+ for *#aces$ Turn the s#ace !utton -denoted !& s#ace or
music notation si"n0 )ust left to &our 3oom !utton on the M*;Word Tool!ar/
on and loo+ at the te%t$ All normal s#aces are shon !& a 29ot4 hile all
hard s#aces ill !e shon !& a 2*mall 1ircle4$ No correct them as
ad,ised earlier$ 1hec+ the sam#le narrati,e "i,en a!o,e !& clic+in" s#ace
!utton to understand this$
MANUAL OF NARRATIVE WRITING
A
WRITING PROCESS FLOW CHART
FAT16E* ARE HUGGLE9 FETWEEN
WRITER* FOR GUALITI 16E1JING
MANUAL OF NARRATIVE WRITING
5
T6E CLIENT A((ROVE* A
(ROHE1T
ALL T6E FILE* 1ONTAINING T6E
RELEVANT 9ATA 1OLLE1TE9
PRO<ECT MANAGER 9E1I9E*
T6E ROLE* OF T6E WRITER* AN9
9I*TRIFUTE* FAT16E* FOR
WRITING IN T6E TEAM
WRITER 1
WRITE*
6I*'6ER FAT16
WRITER 7
WRITE*
6I*'6ER FAT16
MORE E<(ERINE1E9 WRITER GUALITI
ANALI*E* T6E WORJ AN9 MAI JI1J FA1J TO
ORIGINAL WRITER FOR NE1E**ARI
16ANGE* WIT6 1OMMENT*
GUALITI ANALI*E9 FAT16E* ARE FINALLI
16E1JE9 FI PRO<ECT MANAGER AN9
U(LOA9E9 IN T6E E;ROOM FOR 1LIENT
REVIEW AN9 A((ROVAL
GLOSSARY
This is a list of ,er& commonl& used terms$
AE K Ad,erse E,ent
1IOM* Form'Re#ort K *erious Ad,erse E,ent re#ortin" form
1onMed K 1oncomitant Medication
1RF K 1ase Re#ort File
EOT K End of Treatment
GA K Gualit& Anal&3e
G1 K Gualit& 1hec+
ReG1 K Re#eat Gualit& 1hec+
*AE K *erious Ad,erse E,ent
*O( K *tandard O#eratin" (rotocol
TO1 K Test of cure

MANUAL OF NARRATIVE WRITING
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