safety narrative writing or medical writing

5/22/2018 Safety Narrative Writing or Medical Writing

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MANUAL OFNARRATIVE WRITING

CONTENTS PAGE

INTRODUCTION 2BASIC TERMINOLOGY 2NARRATIVE WRITING PRINCIPLES 3RULES OF NARRATIVE WRITING 7CHECKING A WRITTEN NARRATIVE 8

WRITING PROCESS FLOW CHART 9

GLOSSARY 10

MANUAL OF NARRATIVE WRITING

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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 necomersand the initial difficulties faced !& them$ An& further clarification'dou!ts must !eaddressed 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$#l%These are the trials com#anies do to test the efficac& of their dru"as ell as to loo+ for ad,erse effects !efore "ettin" a##ro,al for launch in theo#en mar+et$ 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 #articularsu!)ect are com#iled to"ether on a da& to da& !asis throu"hout the trial andthese are called source files or RF -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 2ouncil for International Or"ani3ations of Medical *ciences40as formed in 15.5 !& W6O and UNE*O$ IOM* form is the standardre#ortin" format of serious ad,erse e,ents hile conductin" clinical trialsorldide to res#ecti,e re"ulator& authorities$

SOP% This is *tandard O#eratin" (rotocol$ Once finali3ed0 this is the "oldstandard to !e stuc+ to0 in letter and in s#irit0 hile ritin" a narrati,e$ It definese%actl& ho the narrati,e ill !e ritten$

N#$$#*+()% Narrati,es are s&no#sis of a #articular su!)ect ho has !eenin,ol,ed in a clinical trial$ It ma& !e of an& #hase and an&here in the orld$ If asource file is ,er& ell documented almost all the information needed for ritin" anarrati,e can !e found here$ In case there is somethin" missin" IOM* re#ort isalso a narrati,e in itself and can "i,e "ood amount of information$


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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


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No loo+ at the folloin" narrati,e and note all these ten sentences formin" thecom#lete !od& of narrati,e$ The sentence num!er is su#erscri#ted in red colorafter 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 valvethickening, 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 seriousadverse 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 seuelae.

[ther adverse events reported during the study were mild butterscotch aftertaste

*+ay 1, which was considered possibly related to study medication, and mildleft arm paresthesia *+ay #1, which was considered unrelated to study

medication. 3oth events resolved without seuelae.4 [5o clinically significant

changes in laboratory values, vital signs, or physical e)amination results werereported 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+ forinformation a"ain folloin" the same order of sentences$

1$ 9emo"ra#hic (rofile and Ad,erse E,ents7$ Medical 6istor&=$ Medical 6istor& and IOM* Re#ort.$ 9osin" section0 IOM* 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 IOM*?$ ausalit& olumn of Ad,erse E,ent *ection@$ onMed *ection$ Ad,erse E,ent *ection5$ La!orator& *ection and Vital *i"n *ection1B$*tud& omments *ection$ Read its different columns carefull& for

com#lete information$


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G'.(l!() /&$ W$*!, # N#$$#*+(%

1 T( H(#.($% This is the first line and ritten in !old$ It includes su!)ect


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O$,#!6!, W$**(! N#$$#*+()%

Narrati,es are or"ani3ed in !atches$ The& are di,ided accordin" to1. *tud& "rou# and then2. Accordin" to their num!er$

The& are further su! cate"ori3ed accordin" to01$ 9eath7$ *AE=$ AE leadin" to discontinuation

If there is a su!)ect ho falls in more than one of the three cate"ories0 asin"le narrati,e is #ro,ided for him'her and the order to !e folloed is thesame 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 seriouscate"or&$ Then there could !e minor narrati,es for the less seriouscate"ories$ 9EAT6 mi"ht !e the ma)or and *AE and 9 ould !e minornarrati,es$


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RULES OF NARRATIVE WRITING

1 S*-l(%The ritin" st&le of all narrati,es of a clinical trial must !e similar$

2 G$##$%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"$

3 S(ll!,)%It ma& !e noted that "enerall& there are to tes of *#ellin"s andthe& are American and En"lish$ Narrati,es are as a rule ritten accordin" toclientsC ishes and it ill de#end here the com#an& is !ased$ onfirm thes#ellin" st&le from *O($

S#"!,%There is ala&s one s#ace !eteen ords and either one -En"lishst&le/ or to -American *t&le/ after a #eriod$ onfirm from *O( hat the clientants$

H#$. S#"() #$. -(!) #l)&:%

H&; *& '*%This is #laced !& ctrlDshiftDs#ace$

T( "&!"(* &/ #$. S#"(%Its conce#t has to !e understood andthen onl& its im#ortance can !e reali3ed$ A normal s#ace can s#litto ords connected !& it in to lines hen it is o#ened incom#uter !ut a hard s#ace0 hich loo+s e%actl& li+e a normals#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$

W($( *& #l-%It should !e a##lied at folloin" s#aces01$ eteen 9a& and its num!er7$ eteen a La! test and its ,alue=$ eteen the su!)ect and its I9 no$.$ An&here else here e ant to connect to ords',aluesinse#ara!l&$

4 CIOMS%Whene,er some information is directl& ta+en from IOM* re#ort0#lace IOM* in #arenthesis after that$


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CHECKING A WRITTEN NARRATIVE

This is re8uired hen oneCs on narrati,e is chec+ed or if one is as+ed to -ualit& hec+/ someone elseCs narrati,e$ One can form an& order !ut a sim#leoutline is "i,en !elo0

1$ hec+ if the lan"ua"e and st&le of narrati,e is *O( com#liant$7$ hec+ 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&$hec+ hat the client ants0 i$e$0 hether En"lish or American s#ellin"sand #eriod #attern$ (ro#er use of comma0 #eriod0 colon0 semi;colon anddash is a must$

=$ hec+ for accurac& of content from source file or IOM* re#ort and also ifall the information as #er *O( is "i,en$

.$ hec+ s#eciall& for small dash -or minus si"n/ hich is automaticall&con,erted to a !i" 9ash hen e te0 i$e$ hen e te0 e$"$0 9a&s#ace dash < s#ace the dash ill !ecome !i" 9ash$ on,ert it to small

9ash or minus si"n as the case ma& !e$-lient s#ecific re8uirements for9ash0 6hen0 6ard hhen0 Em dash0 or En dash/

>$ Finall& hec+ for *#aces$ Turn the s#ace !utton -denoted !& s#ace ormusic 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 allhard s#aces ill !e shon !& a 2*mall ircle4$ No correct them asad,ised earlier$ hec+ the sam#le narrati,e "i,en a!o,e !& clic+in" s#ace!utton to understand this$



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WRITING PROCESS FLOW CHART

AT6E* ARE HUGGLE9 ETWEENWRITER* FOR UALIT 6EJING


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T6E CLIENTA((ROVE* A(ROHET

ALL T6E FILE* ONTAINING T6ERELEVANT 9ATA OLLETE9

PRO


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GLOSSARY

This is a list of ,er& commonl& used terms$

AE K Ad,erse E,ent

IOM* Form'Re#ort K *erious Ad,erse E,ent re#ortin" form

onMed K oncomitant Medication

RF K ase Re#ort File

EOT K End of Treatment

A K ualit& Anal&3e

K ualit& hec+

Re K Re#eat ualit& hec+

*AE K *erious Ad,erse E,ent

*O( K *tandard O#eratin" (rotocol

TO K Test of cure


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