Download - PUBD Training
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Potentially Unblinding Data
(PUBD)
October/November, 2013
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For Internal Use Only. Amgen Confiential. 2
PUBD - Overview
! Intro"ction! #o$ to recogni%e &U'(
! )t"y (oc"ments t*at ientify &U'(
! )O&s, +ANs an FO+s
! &rocesses
! oles
! &otentially Unblining events
- scalation an Notification
- Net )tes
- Conse"ences
! Aitional Information on &rocesses
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PUBD – Introduction
In recent mont*s t*ere *ave been several otentially"nblining events, incl"ing
- &U'( files in "nrestricte folers folers not roerly restricte
or files lace on stanar folers4
- &otentially "nblining information in email to bline staff 5(+4
- )cramble ataset $it* otentially "nblining information
("e to t*e criticality of maintaining a blin for a st"y an
t*e negative imacts affecting everyone, t*is
resentation *as been constr"cte to reinforce roer
roce"res to revent eos"re to &U'(.
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Consequences of unblinding - Data
integrity in question
! ose bline st"y team member may *ave to beremove from t*e trial
! An etreme case co"l be reg"latory a"t*orities
re7ecting ata "e to erceive bias "ring trial con"ct
! 8*ere is a %ero tolerance 9&I/)5A in lace $it* F)&venors
- +onetary conse"ences/enalty may be alie er signe :O
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!ow to "ecogni#e PUBD! &otentially Unblining (ata &U'(4 is any information or ata t*at is collecte "ring
t*e con"ct of an Amgen clinical trial an rior to initial loc< of t*e atabase $*ic*may
- Inicate or infer treatment assignment
- Create bias in t*e con"ct of a st"y
- Imact t*e integrity of t*e clinical trial or ata
! amles of "nblining ata incl"e
- 8reatment assignments
- Antiboy A'4 res"lts
- &*armaco
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$tudy Docu%ents t&at Identify PUBD
! 8*e rotocol is t*e rimary so"rce for efining &U'( an timing fort*e "nblining of t*e ata an treatment assignments. 8*e follo$ing
oc"ments $ill ientify &U'( base on t*e rotocol
- ')+ &lan
- =):/(8&
- )O:/C*arter - ()8: - )): (ata Ac"isition tab
- C*ange Control :or
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$OPs' *s and +O"s! )O&?01B@B6 Foler Access &rovisioning &rocess
! )O&?01>1 Access to estricte (ata
! )O&?000>B6 (isclosing 8reatment Assignments for anomi%e Clinical 8rials
! +AN?001;@ evie$ of &otentially Unblining (ata
! +AN?001>1B Creation, Aroval D +aintenance of t*e 8rial Integrity (oc"ment
8I(4
! +AN?001>1 Accessing an (istrib"ting estricte (ata for Amgen Clinical 8rials
! FO+?0@2366 estricte or &otentially Unblining (ata &lan
! U+AN?0002@; an CE eternal file *anling4
! FO+?00B23> signoff form for "nblining of res"lt ata4
! +AN?000@2 an CE reorting, scrambling an )A) Cs4
! +AN?0010B0 CE lacement of signoff form for "nblining of res"lt ata4
! +AN?0010B2 an CE estriction set " in ave for &U'(4
! +AN?0010B6 an CE E"iance on &U'(, restrictions4
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$yste%s Processes ,&at ay !andle
PUBD! eort generation re"ests
- )crambling
- CA
- 55
- Any C( st"y reort re"est
- 8reatment assignments! ternal (ata
- 8ransfer to eternal gro"
- 5oas to C8('
- 8ransfer to C8)#A( for Non?C8(' or for "nbline gro" revie$
! it C*ec
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$yste%s "ole aut&ori#ed for PUBD
&andling
! As a r"le, "ntil t*e atabase is formally "nbline, t*e follo$ing systems
roles may access treatment assignments limite to t*at re"ire to erform
t*eir role4
- 5ea &rogrammer
- C)I or 8ec*nical )ecialist
- (A/(I &rogrammer
- )A) &rogrammer
- C( &rogrammer
- )t"y (esigner
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&en Potential Unblinding "is. Is
Identified – /scalation and *otification! Any E)O (+ 8A an )ystems incl"ing F)&s4 s*o"l notify t*e follo$ing oversig*t
roles immeiately $*en a otential "nblining ris< is ientifie
- )t"yGs Amgen &5, F)& Os 5ea, Amgen Os 5ea
! refer to the DM Systems ECS Portal for FSP and Amgen Ops Lead contacts
! refer to GMAT for Amgen PL of the impacted study
! Amgen Os lea, F)& Os 5ea an Amgen &5 $ill engage t*e reorter to establis*
initial ris< assessment confirming t*e reorte ris< is not a false alarm
! If it is not a false alarm, Amgen &5 $ill notify t*e follo$ing istrib"tion list immeiatelyan $it*in t*e same b"siness ay of ientifie incient $it* s"mmary etails an
rovie aily "ates "ntil t*e iss"e is close
$u%%ary details to be included Distribution 0ist
1. (escribe *o$ $as t*e ris< ientifie
2. (escribe t*e establis*e start time of eos"reof ris<3. Incl"e root ca"se if available6. Incl"e "nblining eos"re analysis if available;. Incl"e corrective actions an stat"s>. (escribe lanne net stes see net slie4
5ea (ata +anager
Amgen )r +anager5ea &rogrammer/C)I)ystems Oerations +anager 9im :a* 5o$4F)& Eovernance D Oversig*t 8ab #oa4(+ 58 ob 8arney/8ina #arris, 8aras Cariac4&U'( 58 sonsor 8ina #arris4&U'( )r. +anager )+ (avi +cErat*4Cc F)& Os 5ea, Amgen Os 5ea
F)& an Amgen Os 5eas contact information
https://collaboration.amgenpartners.com/sites/CDMSys-513171/default.aspxhttps://collaboration.amgenpartners.com/sites/CDMSys-513171/default.aspxhttps://collaboration.amgenpartners.com/sites/CDMSys-513171/default.aspxhttps://collaboration.amgenpartners.com/sites/CDMSys-513171/default.aspxhttps://collaboration.amgenpartners.com/sites/CDMSys-513171/default.aspx
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&en Potential Unblinding "is. Is
Identified – *e1t $te2s! +$P3%gen O2s 0ead is res2onsible to ensure
- emove ata/o"t"ts immeiately ost acB6 - &er confirmation from Comliance, for confirme non?eose event, o not nee N8F
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Overall Points to "e%e%ber3+ollow
&en !andling PUBD! IPO",*, lt&oug& users are able to create folders in C,$!"/D' only
%gen +$, Business Owners are allowed to create PUBD folders wit&a22ro2riate restrictions
! Al$ays verify t*e correct foler "ner t*e correct st"y rior to lacing &U'(.
! Al$ays c*ec< restrictions on t*e foler rior to lacing &U'(.
! Immeiately notify manager of any otentially "nblining event
! (atasets $it* &U'( ata incl"e t*e $ors HrsltG or Hres"ltG
! estricte foler names incl"e t*e $ors HblineG or HrestricteG
! Never "se ro"ction &U'( as test ata
- Uate $it* "mmy s"b7ects or "se entirely "mmy ata
! Never sen any atasets via email. Al$ays lace on cts*are an sen t*e cts*arefile lin< to t*e re"ester
! Never reference any etails on &U'( recors via email
! Al$ays revie$ email boy to ens"re t*ere in no &U' ata before for$aring or
resoning
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$$ /dit C&ec.s
against C,DB or non-C,DB data
! Any testing s*o"l "se non &U'( ata eit*er "mmy or nonbline ro"ction ata4
! Confirm o"t"t location is acc"rate an t*e foler is restricte aroriately by man"ally
revie$ing t*e foler roerties
! &rogrammer to confirm restrictions rior to r"nning any c*ec
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/1ternal Data! )O:/C*arter/etc
- =enor oc"ment secification s*o"l incl"e bline information
- Covance (+ $ill contact F)& (A Os 5ea if any ne$ )O:s rafts contain
bline information for revie$.
! 8*is revie$ is to verify t*at *anling of t*e bline ata is ac*ievable
! amle is for reeat or "nsc*e"le visits - as &U'( c*ec< r"n by (A cannot
iscriminate by certain "nsc*e"le or reeat visits, it is best to *ave all
"nsc*e"le/reeats as bline.
! (ata *anling - any aitional *anling of res"lts s*o"l be
incl"e in (8&/=):
- As is original bline file sent to reciient or lace in foler
- +as
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/1ternal Data
! (A to eec"te "bc*< for all *eaer ata rior to loa into C8(' an non?ctb
ata files
- &"bc*< o"t"t $ill nee to be revie$e by (A an F)& Os lea to verify
&U'(
- (o not loa ata if any &U' ata fo"n in *eaer file
- (o not lace non?ctb ata files if any &U' ata fo"n in *eaer file
! 5oaing of &U'( ata to C8(' only after signe "nblining form i.e. FO+?
00B23>4 is receive an confirmation from 5(+ to loa &U'( ata. 8*is is tyically
$it*in 3 ays from Initial 5oc<
! Any lacement of &U'( ata on cts*are
- =erify ermissions of foler by man"ally revie$ing t*e foler roerties
- If foler oes not eist, re"est t*e Amgen FA)8 '"siness O$ners +ic
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PUBD C&ec.er Pur2ose
! &"rose C*ec< if t*ere are any val"es in t*e any of t*ebline fiels in *eaer files receive from eternal
venor. 'line Fiels s*o"l be emty in *eaer tet
file
! Fre"ency "n &"b( C*ec
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PUBD C&ec.er "equests
! (A eresentative $ill re"est &"b( c*ec< rogrambe set " for a st"y
! 8*e email incl"es )t"y J, =enor, Fiels $*ic* are to
be bline, =isits t*at s*o"l be bline
! mail also s*o"l *ave =): attac*e
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PUBD C&ec.er Process
!Navigate to t*e at* /cm/ro"ct/st"yJ/lab
! =erify if "bc*ec< irectory eists. If not t*an create it.
- .g. /cm/amg16;/20001;B/lab/"bc*ec<
! C*ec< for rogram arams.sas in t*e foler
- If it oes not eist, coy it from /cts*are/cm/sas/general/scrits/an moify it accoring to t*e re"irements
! C*ec< for rogram for any artic"lar lab in t*e foler
- If it oesnGt eist, e.g. covancea@B;200>[email protected] coy from
/cts*are/cm/sas/general/scrits/
- &rogram Name laba an moify it accoring to t*enees of t*e c"rrent st"y. Name of t*e rogram s*o"l be
la!name aNNN studynum!er .sas, a samle coe belo$
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PUBD C&ec.er Para%s4sas
! Contents of t*is coe1.(ata (irectory $*ere t*e =enor files are
locate
2.=enor Files!. 'asically, efining macro variables t*at *ol t*e val"es
of venor ata irectory an t*e filenames e.g. belo$
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PUBD C&ec.er $et U2 Caller 2rogra%
contd4
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PUBD C&ec.er $et U2 Caller 2rogra%
contd4
! (atafilename C*emlab2 is ta
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PUBD C&ec.er $et U2 Caller 2rogra%
contd4
! (ata ste t*at creates err ataset, "se t*e setnameassigne in earlier ste $*ic* is cl2. 5ist all t*e fiels
"se in fiel list an criteria2, e.g. fieldnameMK K
! 8*e macro call "dump#err call s*o"l list atafilename
e.g. C*emlab24, )"b7i Cevent field_list
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PUBD C&ec.er 5C $te2s
! Anot*er )A) &rogrammer $ill be assigne to =aliate t*e rogram
! =aliator navigates to t*e venorGs foler "ner
/cm/amg$$$ /study#num!er /lab/%endor
- .g. /cm/amg16;/20110233/lab/covance
! =aliator creates a rogram name Hvaliation initialsG, e.g.
HvaliationmsG
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PUBD C&ec.er 5C $te2s Contd4
! =aliator coies files from lab ata foler to valiation foler t*at
$as create in earlier ste
! =aliator t*en in t*e valiation foler renames t*e files insie, e.g.
t*e c*aracters &O( or UA8 $ill be relace by &U'(=A5
! .g.
- a1>200@0;>1?&O(?CO=ANCIN('5UNI8?C#+5A'3?
FU55?2011AUE0;12602;.tt
would be c&anged toa1>200@0;>1?&U'(=A5?CO=ANCIN('5UNI8?C#+5A'3?
FU55?2011AUE0;12602;.tt
- C*anging t*e filename as mentione $ill eliminate
any ossibility of t*e file inavertently being loae
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PUBD C&ec.er 5C ste2s contd4
! =aliator Oens files in valiation foler eit*er in celor any tet eitor
! nters ata into t*e fiels t*at are eecte to be
bline
! efer to =): for fiel attrib"tes s"c* asc*aracter/n"meric etc.
! If some visits are to be bline, ata s*o"l be entere
in a ro$ for at least one of t*ose tyes of visits
! )ave an close t*e files an "bc*ec
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PUBD C&ec.er 5C $te2s Contd4
! On t*e UNI romt, enter comman &U'(C#C9! )ystem $ill romt for st"y n"mber an in"t file
location
! For valiation, in"t file location $ill be t*e valiation
foler
! &"b(c*ec
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PubDC&ec.er Progra% to P"OD
! If t*e "bc*ec
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! ave &"b( (ata
- #eaer (ata gets 5oae into A=
- &"b( ata oes not get loae into A= "ntil "nblining
of t*e st"y
! Non?C8(' &"b( (ata
- #eaer (ata $ill be coming from eternal venor
- If t*e *eaer ata is in 88tet4 format, it s*o"l be
converte to )A) atasetataset name format
nb1, $*ere enotes t*e tye of ata4 an t*e
ataset s*o"l be store in ))( foler of t*e st"y
$cra%bling PubD and !eader Data
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! 8*e re"est to scramble ata comes from - C(+
- E)&
! If t*e &"b( secs are not rovie $it* t*e re"est, as<
for it.! &"b( secs are create by 'iostatistics/E)&. Ieally,
t*ey s*o"l resie in (+ 8eams
$cra%bling a.ing "equests
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! ave ata/cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ss
! es"lt Files
/cm/a%g678/Protocol9/lab/bsm
/cm/a%g678/Protocol9/lab/covance
/cm/a%g678/Protocol9/lab/mrl
$cra%bling $tandard +ile Directories
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! traction /cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ss
! (isg"ise Assignment estricte4/cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssa
! &"b( ata estricte4/cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssbline
! )cramble ata/cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssisg"ise
! )sa an ssbline, bot* nee to be restricte. C*ec< $it*
FA)8 aministrators +ic
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! )tanar +acros Use are at/cts*are/cm/sas/general/rograms/macros
! +acro Calling &rograms at st"y level resie "ner/cts*are/a%g678/inication/Protocol9/cm/sas/ec/rograms/at
aisg"ise
$cra%bling Progra% Directory
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! C*ec< if &at*s4 to es"lt Files are rovie! If not, re"est t*e at*s4 to res"lt files to C(+ or 5ab
Amin irectly
! Once $e *ave t*is "ate t*e calling rograms $it* t*e
ne$ lin< an files as alicable
! *ote A' an &9 es"lt files m"st be in CO format,
i.e. 8ab (elimite. If t*eyGre not rovie in CO format,
re"est it.
! *ote 5ab es"lt files are ie HPG elimite
$cra%bling "esult +iles ("ave)
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! *ote A' an &9 es"lt 88tet4 files m"st be in&O( format, i.e. ie HPG elimite. If t*eyGre not in
&O( format, re"est it.
! 8*e res"lt ata$*ic* is in 88 format4 s*o"l t*en be
converte to )A) ataset. Use t*e conversionrogramsif not alreay eists, create t*e conversion
rogram as er =):4 to o t*e conversion
! *ote 5ab es"lt file $ill be in )A) format)A) ataset4
$cra%bling "esult +iles (*on-C,DB)
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ave! tract elevant A= ata "sing C(+)2)A)
- .g. 5A', A', &9 etc.
- 8*is $ill etract t*e ata "ner Q../ata/ss
- C*ec< an confirm t*at ssbline an ssa bot* are
restricte.
Non?C8('
#eaer ata.g. nblab1, nbab1, nb
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!If t*e rogram are not alreay set ", set it ". 8*is canbe one by coying vario"s rograms from ot*er st"y
an moifying it accoring to t*e nees
! &rograms resie "ner Q/rograms/ataisg"ise at
st"y level
Process (contd4)
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! "n +a
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! 8*is ata is store "ner
/cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssbline
! =ario"s &rograms t*at create Unblining ata are
o ea'lineA'ave.sas
o ea'line&9ave.sas
o ea)ynarc'line.sas
o ea'line5ab.sas
! :*at t*is oes is eas t*e es"lt Files, merges $it* #eaer ata an
t*an creates t*e "nbline file $it* bline ata t*at is store "ner
ssbline $*ic* again is a restricte irectory
! O"t"ts from t*ese are e.g. lab", ab",
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! 8*is ata is store "ner
/cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssbline
! =ario"s &rograms t*at create Unblining ata are
o ea'linNONC8('Ab.sas
o ea'linNONC8('&
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! Oen t*e relevant )A) 5og
! C*ec< if t*ere are any errors resent. If t*ere are any errors,
ossibility is t*at in t*e macro calls, $rong filenames or at*names
are given. 8*ere may be some ot*er reasons t*at nee to be
investigate if errors are "e to some ot*er reasons
! C*ec< for A58 message. A58) are resent in case of t*ere isany mismatc* of t*e ata, i.e. recor eists in res"lt files, b"t
corresoning recor oes not eist in *eaer file. .g.
A58 (ata from res"lts file oes not *ave a matc*ing *eaer recor
in 5A'A55 t10>>61001 Foler:6B )A)NA+A&O'
A58 (ata from res"lts file oes not *ave a matc*ing *eaer recor
in 5A'A55 t10>>61001 Foler:6B )A)NA+5(5(
$cra%bling 5C $te2 for Creating
Unblinding +ile
$cra%bling ,o "esolve is atc&es of
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!Contact (A or ')+ as alicable, rovie t*ese alertsan re"est to c*ec< an get t*e "ate *eaer file.
)to rocessing t*e file t*at *as A58).
! For 5abs, only rovie t*e alert as in eamle above. (o
NO8 rovie =I)I8 (ate, =I)I8 (ate a$ or =isit 8ime.8*ese are act"ally resent in )A) 5og, b"t $*en
roviing t*e A58 to t*ese fiels nee to be ta
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! )cramble ata resies "ner/cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssisg"ise
! &rograms t*at create )cramble ata are
o +a
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! )cramble ata resies "ner/cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssisg"ise
! &rograms t*at create )cramble ata are
o+a
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! N"mber of ecors in " an s*o"l matc*.
! C*ec< ata against &"b( secs. All variables er secs m"st be resent.
! C*ec< if t*ere is any restriction on n"mber of "ni"e s"b7ects in isg"ise ata
mentione in t*e )&C. If yes, t*e lin
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For Internal Use Only. Amgen Confiential. 6
! Any ata t*at is NO8 &"b( is consiere to be #eaer
(ata
! ntere into ave for ave st"ies
! For Non?C8(', t*e *eaer ata $ill be rovie by t*e
eternal venor
! At t*e en of t*e scrambling rocess, coy *eaer ata
e.g. 5abAll,nblab1for Non?C8('4 from ss to
ss*eaer.
$cra%bling !eader Data
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For Internal Use Only. Amgen Confiential. ;0
! At t*e en of t*e rocess t*e follo$ing o"t"ts are eecte
7"st "sing labs for eamle4
! 5A'U or blab1"for Non?C8('4 &"b( (ata store in
ssbline
! 5A'( or blab1for Non?C8('4 )cramble (ata
store "ner ssisg"ise
! 8*en from ss irectory, 5A'A55 or nblab1for Non?
C8('4 coie over to ss*eaer
/cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ss
*eaer
$cra%bling Out2uts in *uts&ell
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For Internal Use Only. Amgen Confiential. ;1
! Fail"re to c*ec< )A) 5ogs of t*e relevant rograms
! Using $rong Files
! Use Coy an &aste, b"t forget to "ate t*e coe er secs
! +or labs in C,DB' %issing calculated $I values in t&e scra%bled out2ut
- In orer to calc"late t*e )I val"es, t*e analyte "nit an conversion factor from reorte "nit to )I "nit4 m"st
be set " in ave 5ab Amin mo"le for t*e analyte. In aition, t*e range secifically t*e *ig* range4 m"st
be assigne to t*e analyte for t*e lab venor "se for t*e st"y.
- "e%ediation
! If conversion factor is missing, 5(+ to confirm $it* 5( if t*ere is an available conversion factor. If so,
t*e conversion factor is to be arove an ae to t*e analyte in t*e ave 5ab Amin +o"le. If no
conversion factor is available, )I val"e cannot be rovie in t*e scramble ataset - only reorte
val"es
! If only t*e range is missing, 5(+ to confirm $it* 5( if tetboo< ranges are available for "se in t*e
st"y. If available, 5(+ to re"est to "ate ranges for t*e st"y. If not available, 5(+ to re"est "mmy
ranges to be "se i.e. 0?4. Note, t*e "mmy range selecte s*o"l be s"c* t*at none of t*e res"ltsare falsely flagge as abnormally lo$ or *ig*.
$cra%bling Co%%on Issues
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For Internal Use Only. Amgen Confiential. ;2
! Create a ate foler, e.g. October2012 "ner eac* ssbline, ssisg"ise
an ss*eaer, eening on $*en t*e ata is re"este
! +ove all "nbline/&"b( ata from ssbline irectory to t*e +ont*year foler
create "ner it.
.g. +ove :u files from /cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssbline
to /cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssbline/+ont*Rear
! +ove all )cramble (ata from ssisg"ise to t*e +ont*year foler create "ner
it.
.g. +ove :d files from /cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssisg"ise
to /cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ssisg"ise/+ont*Rear
*O,/ ,&e $0 to 2rocess PubD is ; Business Days4 In case of *ew studies t&at need t&is set u2' it %ayta.e a day or two additional4
$cra%bling +inal $te2s
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For Internal Use Only. Amgen Confiential. ;3
! #eaer (ata "ner ss irectory to be CO&I( over
from ss to ss*eaer/+ont*Rear
.g.
COP7 :all filesrelate to t*e ata being scramble4
from/cts*are/a%g678/inication/Protocol9/cm/sas/ec/a
ta/ss
to
/cts*are/a%g678/inication/Protocol9/cm/sas/ec/ata/ss*eaer/+ont*Rear
$cra%bling Co2y !eader Data
$cra%bling $ending 0in.s to t&e
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For Internal Use Only. Amgen Confiential. ;6
! 8*e email *aving t*e re"est to scramble ata may
*ave information on $*o to sen t*e lin
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For Internal Use Only. Amgen Confiential. ;;
! Once t*e ata *as been rocesse an all stes CGe,
sen t*e ata manager an bline E)& rogrammer
lin
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For Internal Use Only. Amgen Confiential. ;>
! )en t*e lin
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$cra%bling $a%2le PubD s2ecs