Data Presentation for FDA Submission

1. Data Prsetatau r DA Submusuow
Study data standanas: Desibe stuolara
Clinical olata +
Non-chucaldoata
Research
exchawge
bet" conputer syetet
Data Standarcls: Provicdes Consisten genera
rame wovk for ogcw 3ig
Study dlata
leuplates of datasats
Std names of vamables
FDA New requiyemetufor olata stds
Std.ways for calculoubue
C Common vamables.
Most o Sruoy oata submissio
TBWOrCls CDER& CBER.
FDA may retuse NDA, BLA o7 ANDA
Cele suSmissiane LS well if Stuoy
data NOT COnfosms tome Stds
specitiel in the FDA Data Std.
Cotalo que wiHo ther technical
dlocuments like " Study Data Con
To assist cO
t
Sponsom ORejectio ntena Self-check workskt
Sum w0Tkshet nstmuctron
Stuoydata.

2. CDEP &CBER Shronaly encour
LNDSponsorsLNDAppliconh for
Implemeuctatinu + use of studyS
Design + accout + amalusis of studies
Sponsor3
For
IN Ds
OStudies
after 17/ha/201c
starts Reauurumeuts for
For
Study
Start,
Data"
applies
Subnut data
in tom ats
Supported: FDA
listed: FDA
Data std.cataloque
aPplies t
NDA +BLA ANDA
Stucy stoed
otes 17H12/2017
details C
def a
Study stat
Da
Final
oefe
uidlace for
Thdus tr
Popidn
Requlodo
SulbmisAies
In elec.tomat'.
Subseguet submisscKA
hese applicatrons
Study must be In toma Suppote.d by FDA
dotostd.catalague
lis ts all data standards
Supported by FDA deadlines

3. Study data stndaads deve ped
8
wrth callabovatrom
Irfeo
FDA F NamuprofF CDIsC
0hir Stake.Cliical data
holdes Lnterchdnge
Std. Cososium
Cumety Supported odotastd
CsDSCExcha.nge olou-clinicdldata (SEND
oLAtasetsSTa
2CDTScstuslyDota TabulatrauMadelCsoTM)
aauysis Nau-elinical data
b
Analysiso clinical olata
CDIsC Analyo?Daka.Madel CADaM)
AMalgsis clunical datu.
Metadatoa: set o olala descnbes &gives iwto boutE
othosdata
() CDISc Case Teports Tabulatron Ma-ettet ¬ Data
Defiction Speclacatran Define -XML)
for mtadata o occOmpayivg
SEND, SDTM &ADaM.
datasets

4. FDAS Pvceclurs tor updatg Std
O/FOA DA DA FDA
Perio
dical
Publisk
Puopose to
beginsupfortd
Neo stds
One yea
Natuce
before
Support
to derlop
Cinica
Terminaloa
Std.
L
Pasticular
Thusapetic
area
witinSDTM
Fer tirly
Mew sfdds
s t d a t h e .
fwo
Natre:
at least
new vemi0n
New vesions
afcunnt
Stds
7euiredl
SDTMupdatacd pemodically
fe incucdle new
Rerised std
Speciic fherapedic
Maclec
- Clinical
Stucly
Pepats
ameos
TCH +FDA
Per al ICH CTD 1magle
Submission
MadulL1 Madule2 Moduule3 Macluleh
-CTD
enural
Tufom
gualit Non-cical
Stucy Tepests
Summames
Module1
Admi nustoatire iu
Prescmbig iutoom

5. Spetific to eath regio
eaApp form: pmposed label
for
use
speiltfor
Spe& regiau
Coveingletter + table ol conteust
Gneral ih d pdt
Madule2:CTD suynivoet
QOS Qualy orerall sumnoy CNMTH0pages
Lexcud
Tables Cip
Qutline a olata presente.d +
mmdude 3
NOn-cwical
OVerview
CTitical ass
P'calogic+
Clinical
Oveavieu
-Summa
NaM-clincal
Summames
Summ0
PK,P'cological
toxicelogtcad
cliical
Suumasoes
Detailed
factud
PK+oxicelagical Analysu Studie
gical
Swna
a l l d
CtalJu
- clinicalstudl
rports
Mataana
0her C0S
Stuoy Aa.
tFullepastsin
ModullS
eyaluatos clouical
oata
tM-vIVO iHVid,
Speues, t
Rowte + Dur
Pceucical
Overview
gelgendor
7elalad
coucal
finougs
- Bemetits
iska
kcts
Medicinal
Pmductr Post maskatn
data
- saley tca
1saue
wmsolved issues
Pav ducti
marketed
n Othr Teg
Bass :
ip.0 unusudl
aspects

6. Maduo,3 Qualily)
CED
MAQ Proper stnuc hwe
CTOH guL
Fomnat
Preseutna C Chtwisty
M Mf
Couto
OTable coteut +Bod
daka
Lteratwe rierenes.
DT Infe Drg PToduct
Drug sulbsCfovfile)
0 DesCipthons, Pcadi-
dewelopmuut
Manufactu
e.Name structure
eXupieh
Ref Std, coutaieas
Stab Iete
Module hNon-cinicdl
StuclyKepostz
fomnat2 ooganusdtro
Na-clinical dlata applicatita.
means
Kalevaud
Phamatolagtcal
To xicalngical

7. Studyreportsincudes (7
P'colog Toyicoln
Toyicalogy Ltreteences
Pkinetidc
Maduwl 5 cinical stud
Kepor
Fomals +oogausatro
Kepovts
post
Maat
lvCLub to Applicatran eperie
cunical olala
d
Repats a
Biophammateuticau
Stuolies
Koports a KepOrts
Hwn.ou
Repoots a
EHHcacu
Huw Satty
PD
PK
Studies Studies
quudavmce Documeu CTD
M4
ucle. M4 eneral.
Qualy CTD
MAE
efficau
MS
Sate

8. ECTD
develaped by TcHM2ewG
CMudtidisuplinor
Specifications f2pet
work
froup y
elecauulesubmisile
rocpplicaut foregulatar
M2
El chouge cowtralpoocess
MOltor: iwplemetatrd prLcen
Provides Saluiitns
foperCTTD eCTD
Fe folders
Docwmut
les Paper submissle
placecdT electyouc
Suub
XML fles CExfensible Maakup Laug
-Fileformats: PDP/X ML CText fla)
Twages/guphs JPE/PNG/GTf:
oner resol

9. Specutc Nomeunclotue
e Namw-22-Tbe
1)CTD Mamolotey tor 2u
Sulomus4 (Ds
Lpet 2 Ma Marke
pproval
Neuw d Fwis kad polt
New dosagetom
New indiotaou,
New rouo claclw
iet e
Suowissio
SubseaUeN opp
Mediied Aftery year
Uewe
TOm hauig CDSCO appoval
Pixed Da.se Appendix VI of
Can ckeoluul Y DECAct