I"troductio"-

rerea.rct.. to ,:4,:te,.,_o.tico.lly collect do.to. fro,.,_ eo.rticipo.,,, t,: ;,, ,,_ ,1,·,,;,t>.f trio.I 01
,:tudy. It server o.,: tt..e pri"'-o.ry to11I for rec11rJi.,9 ;.,f11r..,o.ti11>i a.bout e1>.ch
;.,Jividuo.l po.rticipo.>it over the cour<:e of the dvdy.

_I The CR.Fi,: de,:iq>ied to cy ture ,:pec;f;c do.tt>. N i.,t,: relevo."t to tt..e ,tvdy'<:
I obiective,:. It cohto.i>i<: vt>.riou, <:ect,'o"f &,r recordi"q dett>.,lr ,:vet.. t>.<:

l C/i>iico.l re,eo.rchen u,e CRF,: to ei.,:vre ,11.,r,'de>icy o.>id o.ccuro.cy ii. dt>-to.
collectio" o.cro,:,: di/fere"t ,tudy ,:ite,: ,,_.,,1 o.>no"9 vt>.riour i"verti90.tor,:. It
help,: "'-O.ii.tt>.i>i the i>ite9rity ,,_,,J rel,-...bi/,'ty of the ,:tvdy',: f;,,J;.,q,:.

The i>ifor,.,_1>.tio" rec11rded ;., o. CRF i,: typico.lly bo.,:ed 11" tt..e ,tudy er11tocol,
_I .,,t,_;,h 11vtli.,er the dudy',: obiective<:, deriq", >neth11doloqy, ,,_.,,1 ,:pec;f;c dt>.to.
poi>i f<: to be c11l/ected. The CR.F o.ct, o.,: t>. to..,qible record of the i>ifor,.,_o. fio.,
91>.thered duri>iq tt..e ,tudy, ,,_.,,1 it',: ,,_,, e,<:e>i fio./ co>nfo>ie"t of cl,·,,;co.f
rereo.rct...
Co.,,.pui.e,,,t, of CRF-
_I_________________
A C1>.re Report Fur"" (CRF) ir " tfttr,d1>.rdized docu""e"'t u,ed ;,, c/i,,ical
rereuch, fo cullect d1>.ttt fro.,,. p1>.rticiM,,,t, ;,,, a. dudy. It t'fl'ictt{ly ii,,.cluder

Hettder Ji,,.(on..tttio,,: Thir sectioi,,. cu,,tfAi,,,r deta.,"/, like the dudy fit/e,

de,.,,uqra.phic defa.ilf.

J,,,terve,,t,·o,,, Deta.ilr: J,,,fo,,.,,.a.tioi,,. a.bout the tre1>.t~i,,.t or ii,,.terve,,,tiui,,. be,,,,

1>.d,.,_,,.;rtered1 ;,,,c(uJ;,,q dortt9e1 freque"'c'f, 1>.,,,d ""Y rpecif;c ii,,.rtrvctiui,,.r.
Folluw-Ue V,"r;tr: Thir ,ect,"o,. uvtlii,,.er the rchedule for fut/ow-up .,;,;tr,

Adverre €vei,,.tr: A rect;o,,, for recorJ;,,q ""''i vi,,.eqected or u,,,desirttble eve,,t,

ex.eer,"er,ced by fhe pttrticif""'t dvri,,q th,e ,tvdy.

trettf.,,.e,,tr the pttrf,"ciptti,,.t "'-"Y be receiv,",,q ;,,, !>.ddit,i,,, fu th,e ,tudy

i"'terve1-1fifl"'- -

[1>.bura.tory Te.tr: Rerultr of 1>.i,,.y lttbor1>.tury tedr co,,,Jucted 1>., pttrf of the
Pt-otr,col o(CRF-

The p,-r,tocol 17( o. CMe Report F17,-..., (CRF} refer!: to the defo.iled p/o.,., thAt
outl,·-.e1: /,.r,w tl..e CRF will be vred i,.. o. spec,{ic c/i,,, iu;./ dvd9. It provide,
t:pec,{ic ;,,,,tructio,,,, A,.,d 9uit/A,,,ce o,., l..ow tr, co.,,plefe tl..e CRF Mcuro.tefy
A,.,d cr,,.,r,·,te,.,tlq. Here o.re ,,,...,e efe.,,e,.,t, tqpica.fly ;,.,eluded;,., the prr,tocof ,,f
A RF:

Purpr,<:e A,.,d Obiecfiver: It out/i,.,er the overa.ff 90A!r a..._,I specific r,biecf;ves of
tl..e ,tud'f, A!: we{/ o.r the rr,le of the CRF ,-,., Achievi,.,q tl..r,<:e obiective<:.
I...strucfio,..s fo,- C17mp/eti"'-9 the CRF: This ,ectio"' prr,vit/es expl,·cit 9u,tfA,.,ce
o,., h17W to {ill out eAch t:ectio,., r,f the CRF. It "'-AY ,,.,clvt/e def; ... ,'tir,,.,,,
exa.mp/er, A,.,d ,peci{ic cri(eriA fr,,- recor<f,,,,q <lo.ti,..
DAta. Def;,,,itio .. s {At,,.,/ Cr,di... 9: This pa.rt def;,..es the te,-....r {At,,.,/ va.r,t,.bfe, vrea
;,.. the CRF. It "'-AY i...clvt/e rfa.,..do.rt/ized code, 17,- def; ...itio,.,, for ,pec,{ic

DAta. Coflectio"' 0,1.. edu/e: The prr,tocol qeci{iet: whe,., o.,,,d how r,fte.._ t/Ata.
1:l..ou/t/ be collected fro,.,_ pa.rtici1>Mtt: vri"'-9 the CRF. It outt,·,.,er the rchedule
for fr,/fow-up vi,itr A"'-t/ a.s,ers"'e,..t,.

iuerfioMa.iret: tha.t rhould be vt:ed ,.._ co,,,iu,.,cfio,., with the CRF.

Oua.lity Co,.,trr,/ Procet/ure,: Thir ,ect,o"' r,vtli...et: procedure!: fo,- e,..rvri,.,q the
Accuro.cq, comp/ete ...et:s, A,..d re/,t,.b,1itq of tl..e do.tA recorded;,.. the CRF. It

9uido.Me ""' how to ha.,.,d/e t:ituo.f;,,,.,r where certo.i"' <la.to. po,,.,t, o.re mi,r,·,,,q
or ;,,, co"' lete.
for fullow-ue vi,,'tr ,,_.._,1 os,e!:!'>ne,,,t,.
Referei,,.ce Mt1.terialr: It "'-AY ,,,,cfude ""Y refere,,,ce >nAteriA!!:, !:cA!e!:, or
iuerfi0Mt1.ire1: tht1.t rhould be uwl '" co.,ju,,,cfio" with the CRF.
Quality Co,,,tn,I Procedure" This- ,ectio" uutl,'M!: procedure!: for e"!'uri,,,q the
1Accurt1.cq1 co,.,,plete ... e!:!', ,,_,,,d rel,P.bi/itq of th.e do.tA recorded,,,, the CRF. It
>nAq ,..,elude >nethodr for dt1.to. verif;co.tiu., ._.._,t vA!ido.tiuk.

9uido....ce u., how to ht1.,,,dle 1:ituo.fiuh!' where certo.i" dt1.to. po,,,,t, ..,.e ,.,_,,1:i.,q
or ,., co>n lete.
Adver!:e € vei.t Repudi.,q: If ApP/,'co.ble, th.e pn,tocol "'-"Y ;,,,elude r1>ec,6'c

D1Att1. €.,fry ,,_,.,1 Mt1..,o.9eme.,t It "'-IAY qeci& dett1.ik Abuut how the co//ecte,
dAtt1. w,11 be e"tered ,.,fo A dt1.to.blA!:e or electro,,,,c ,vde,.,, ,,_,,,d whu is-
re!'PuMible fur th.i, tMk.
D1Att1. tf1o.,ituri.,q ,,_,,,d Audit,.,q: This- ,ectioi. "'"-Ii de!:cribe procedure!: for
,.,o.,ifor,.,q dt1.tt1. qut1.l,·ty ,,_.,,1 cu,,,duct,.,q t1.udit, tu e.,,ure co>nplit1.i.ce with the
ro ucol.
Co,,,f;de ... t,P-lifv ._.,d Re9ulo.tor4 Cutnpl,-,.,..,ce: The prutocol 1:h.uufd e"'-ehosize th.
i,.,pudo..,ce i,f,,,_..;... tt1.i.,ii.9 pt1.dicift1."t co.,f;dei.ti..litv ""d o.dh.er,,,,q to All

u"der1:to.i.d the pri,toco/'1: i'1dructio.,,.

The prutoco( i,f o. CRF i!: " critictl./ docu>ne"t tho.t help, eMure ci,.,,irte"t
,,_,,.d t1.ccur1Ate dtl.tA ci,llectii,.,, wh.ich is- e,!:e.,tio.l for "'";.,t,,_,,,.,;.,q th.e ,cie.,tif;
i-,te9rity oft1. cli-,ict1.I !:tudy. It rerve!' ._, IA deto.iled quide for All per!:0'1MI
i-,vi,lved ii. th.e ,tudy, fro,., ,.,vedi9t1.torr to dtl.to. collector,.