1.

Record Nr.

UNISA996259850103316

Autore

STELLA, Giacomo <1949-    >

Titolo

Nessuno è somaro : storie di scolari, genitori e insegnanti / Giacomo Stella, Marina Zoppello

Pubbl/distr/stampa

Bologna : Il mulino, 2018

ISBN

978-88-15-27485-4

Descrizione fisica

160 p. : ill. ; 22 cm

Collana

Contemporanea ; 273

Altri autori (Persone)

ZOPPELLO, Marina <1969-    >

Disciplina

618.9285889

Soggetti

Bambini - Apprendimento - Disturbi - Valutazione [e] Riabilitazione

Collocazione

II.3. 4239

Lingua di pubblicazione

Italiano

Formato

Materiale a stampa

Livello bibliografico

Monografia



2.

Record Nr.

UNINA9910154889203321

Autore

Holland Chris

Titolo

Implementing CDISC Using SAS : An End-to-End Guide / / Chris Holland, Jack Shostak

Pubbl/distr/stampa

[Place of publication not identified] : , : SAS Institute, , 2016

©2016

ISBN

1-62960-538-7

Edizione

[Second Edition.]

Descrizione fisica

1 online resource (294 pages)

Disciplina

519.53602855369

Soggetti

SAS (Computer file)

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

About This Book -- About These Authors -- Chapter Summary -- SDTM Metadata and Define xml for Base SAS Implementation -- Implementing the CDISC SDTM with Base -- Implementing CDISC SDTM with the SAS Clinical Standards -- Implementing the CDISC SDTM with SAS Clinical Data Integration -- SAS Clinical Data Integration Study Setup -- ADaM Metadata and ADaM Define xml -- Implementing ADaM with Base -- CDISC Validation Using -- CDISC Validation Using Pinnacle 21 Community -- CDISC Data Review and Analysis -- Integrated Data and Regulatory Submissions -- Other Topics -- Source Data Programs -- SDTM Metadata -- run_p21v SAS macro -- Copyright.

Sommario/riassunto

For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS, the first comprehensive book on applying clinical research data and metadata to the Clinical Data Interchange Standards Consortium (CDISC) standards. Implementing CDISC Using SAS: An End-to-End Guide, Revised Second Edition, is an all-inclusive guide on how to implement and analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission. Updated to reflect the 2017 FDA mandate for adherence to CDISC standards, this new edition covers creating and using metadata, developing conversion specifications, implementing and validating SDTM and ADaM data, determining solutions for legacy



data conversions, and preparing data for regulatory submission. The book covers products such as Base SAS, SAS Clinical Data Integration, and the SAS Clinical Standards Toolkit, as well as JMP Clinical. Topics included in this edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new versions of SAS and JMP software. The second edition was revised to add the latest C-Codes from the most recent release as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes. The metadata spreadsheets were updated accordingly. Any manager or user of clinical trial data in this day and age is likely to benefit from knowing how to either put data into a CDISC standard or analyzing and finding data once it is in a CDISC format. If you are one such person--a data manager, clinical and/or statistical programmer, biostatistician, or even a clinician--then this book is for you.