Data Presentation for FDA Submissions.pdf

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
leuplatesof datasats
Std names of vamables
FDA New
requiyemetufor olata stds
Std.ways for calculou bue
C Common vamab les.
Most o Sruoy oata
submissio
TBWOrCls CDER& CBER.
FDA
may retuse NDA, BLA o7
ANDA
Cele suSmissianeLS 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
Stuoy data.

2. CDEP &CBER Shronalyencour
LND Sponsors LNDA ppliconh
for
Implemeuctatinu + use of study S
Design
+ accout + amalus is 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
D a
Final
oefe
uidlace for
Thdus tr
Popidn
Requlodo
SulbmisA ies
In elec.tomat'.
SubseguetsubmisscKA
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 stndaadsdeve ped 8
wrth callabovatrom
Irfeo
FDA F NamuprofF CDIsC
0hir Stake.Cliical data
holdes Lnterchdnge
Std. Cososium
Cumety Supported odota std
CsDSCExcha.nge ol ou-clinicdl data (SEND
oLAtasetsSTa
2CDTSc stusly Dota Tabulatrau Madel CsoTM)
aauysis Nau-elinical data
b
Analysis o
clinical olata
CDIsC Analyo? Daka. Madel CADaM)
AMalgsis clunical datu.
Metadatoa: set o olala descnbes &gives iwto boutE
othos data
()
CDISc Case Teports Tabulatron Ma-ettet¬
Data
Defiction Speclacatran Define -XML)
for mtadata o occOmpayivg
SEND, SD TM & ADaM.
datasets

4. FDAS Pvceclurs tor updatg Std
O/FOA DA DA
FDA
Periodical
Publisk
Puopose to
begin supfortd
Neo stds
One yea
Natuce
before
Support
to derlop
Cinica
Terminalo a
Std.
L
Pasticular
Thusapetic
area
witin SDTM
Fer tirly
Mew sfdds
std athe.
fwo
Natre:
at least
new vemi0n
New vesions
af cunnt
Stds
7euiredl
SDTMupdatacd pemodically
fe incucdle new
Rerised std
Speciic fherapedic
Maclec
-Clinical
Stucly
Pepats
ameos
TCH + F DA
Per al ICH CTD
1magle
Submission
MadulL1 Madule 2 Moduule3 Macluleh
-CTD enural
Tufom
gualit Non-cical
Stucy Tepests
Summames
Module 1
Admi nustoatireiu
Prescmbigiutoom

5. Spetificto eath regio
ea App form: pmposed label
for use
speilt for
Spe& regiau
Coveingletter + table ol conteust
Gneral ih d pdt
Madule2: CTD suynivoet
QOS Qualy orerall sumnoy CNMT H0pages
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
cliic al
Suumaso es
Detailed
factud
PK+oxicelagical Analysu Studie
gical
Swna
alld
Ctal Ju
-clinical studl
rports
Mata ana
0her C0S
Stuoy Aa.
tFull epastsin
Modull S
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 sulbs Cfovfile)
0 DesCipthons,Pcadi-
dewelopmuut
Manufactu
e.Name structure
eXupieh
Ref Std, coutaieas
Stab I ete
Module hNon-cinicdl
Stucly Kepostz
fomnat2 ooganus dtro
Na-clinicaldlata applicatita.
means
Kalevaud
Phama tolagtcal
To xicalngical

7. Study reportsincudes(7
P'colog Toyicoln
Toyicalogy LtreteencesPkinetidc
Maduwl 5 cinical stud
Kepor
Fomals +oogausatro
Kepovts
post
Maat
lvCLub to Applicatraneperie
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 TcH M2 ewG
CMudtidisuplinor
Specifications f2pet
work
froupy
elecauule submisile
ro cpplicaut fo regulatar
M2
El chouge cowtral poocess
MOltor: iwplemetatrdprLcen
Provides Saluiitns
foper CTTD eCTD
Fe folders Docwmut
les Paper submissle
placecdT electyouc
Suub
XML fles CExfensi ble Maakup Laug
-File formats: 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