Data Presentation for FDA Submissions.pdf
- 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