Results and Lessons from the CDISC SDTM/ADaM Pilot Project

Results and Lessons from the CDISC SDTM/ADaM Pilot Project

http://www.bettermanagement.com/seminars/seminar.aspx?mode=play&L=14684

Get registered free… and listen to 1 hour Audio seminar by…
Cathy Barrows, Ph.D
Chris Holland
Edvard D. Helton, Ph.D
Tanyss Mason

Program Content:

The CDISC SDTM/ADaM Pilot Project was conducted as a collaborative pilot project with FDA and Industry. The objective of the pilot project was to test how well the submission of CDISC-adherent datasets and associated metadata met the needs and the expectations of both medical and statistical FDA reviewers. In doing this, the project also assessed the data structure, resources and processes needed to transform data from a data source into the SDTM and ADaM formats, and to create the associated metadata. An additional goal was to produce a worked example implementation of the CDISC standards available at that time, including the Define.xml file.

This webcast will review the experiences, results, and learnings of the pilot project core team regarding the creation of a CDISC-adherent submission. Key aspects of the worked example will be highlighted, as will issues to keep in mind while exploring the example package (e.g., improvements or changes made in standards that are not addressed in the package).

Perspectives on the pilot project will be presented from CDISC and from the FDA, with a live question and answer session at the conclusion of the presentation.

Please note: The comments, statements and opinions attributed to regulatory review team members reflect views of those individuals and are conveyed as informal feedback by the pilot project team in the spirit of effective information sharing, and must not be taken to represent guidance, policy, or evaluation from the Food and Drug Administration.

Learning Objectives:

Gain an understanding of the logistics and processes used in the CDISC SDTM/ADaM pilot project

Hear key points deemed worthy of emphasis: the successes, the snags, and the solutions and work around that went into the successful completion of this pilot

Learn from the pilot project experience what things to consider when planning for your own CDISC submissions

Hear from FDA the positive effects of CDISC data standards on the submission and review process.

Implementing CDISC Submission Data Standards (audio seminar)

Presented By:
Rebecca Kush, Wayne Kubrick, Dan Godoy, Ed Helton
www.cdisc.org

Learning Objectives

Understand the current state of the CDISC SDTM and ADaM submission standards and the new define.xml standard

Gain insight on representative ways to effectively implement the SDTM and ADaM in Sponsor organizations

Understand some of the challenges and common questions that arise when implementing these standards

Learn about the experiences of Astra-Zeneca, a global pharmaceutical company in the process of adopting CDISC standards.





Free webinars on CDISC/SDTM/ADaM:

Importing Excel/DBF Files to SAS Datasets Using DDE

Importing Excel Files Into SAS Using DDE

What in the world is DDE and why use it? Good question... DDE is “Dynamic Data Exchange” and is a method of accessing data from one MS-Windows application by another. As a SAS user, you can use DDE within a DATA step to import data into SAS and export data from SAS. Using DDE involves SAS code and statements that other MS-Windows applications understand. But, why bother with DDE when other methods are available? What about the IMPORT and EXPORT procedures? Or, Open Database Connectivity (ODBC)? How about SAS Enterprise Guide? These alternatives are useful under the right conditions. For example, the PROC IMPORT and PROC EXPORT are simple to use, but are limited in the way you can define your data and these procedures require you license SAS/ACCESS For PC Formats. Bummer. ODBC is also simple to use, but importing data into SAS using ODBC requires you license SAS/ACCESS For ODBC. Bummer again. And, the new Excel LIBNAME engine? Oh, that also requires you license SAS/ACCESS For PC Formats. Bummer times three. SAS Enterprise Guide is very simple, and does not require you license anything other than BASE SAS. Hmm. Oh yes, SAS Enterprise Guide doesn’t offer quite the flexibility as DDE, because when using DDE you have all the features of the SAS DATA step. Also, using DDE in a SAS DATA step makes it easy to adapt the import process for repeatable uses. A SAS DATA step using DDE only requires BASE SAS running under MS-Windows.

DATA TRANSFER TO AND FROM EXCEL WITH DYNAMIC DATA EXCHANGE (DDE)




Importing DBF files to SAS Datasets

Multiple Graphs on One Page Using SAS/GRAPH® V9

I am not sure what other fellow SAS Programmers think about SAS Graphs, but I think they are easy to generate than tables…. I was amazed by how easy it was to get more than 1-2 graphs in single page.

While surfing on the net, I found a nice SUGI paper which deals with the ways of putting multiple graphs in one single page.

This paper provides 3 different methods (PROC GREPLAY, the Data Step Graphics Interface (DSGI), and ODS LAYOUT) to put multiple figures on a one single page.

Multiple Graphs on One Page Using SAS/GRAPH® V9

20 SAS Macros Tips in 30 Minutes

20 SAS Macros Tips in 30 Minutes

Need to convert SDTM data to ADaM data? Here's How

Need to convert SDTM data to ADaM data? Here's (Clinplus Report)

Introduction

If you have you been wondering how you can effectively meet the clinical data study standards set out by the Clinical Data Interchange Standards Consortium (CDISC) specifically with regards to the Study Data Tabulation Module (SDTM) and the Analysis Data Model (ADaM) our data conversion and reporting tool may be the solution you are looking for to generate all of your safety tables and listings and provide supporting documentation in a validated, standardized ADaM compliant manner.



A Taste of SDTM in Real Time



Do we need to create ADaM dataset for each SDTM dataset?

By Jack Shostak:

You do not need to create an analysis dataset for every SDTM domain. The SDTM files can be used as-is (and probably with support from ADSL for key analysis variables) for statistical analysis if you can get away with that. The idea with analysis datasets and ADaM is that ADaM datasets are value added. ADaM doesn't want to create busywork for you. The top of page 9 of the draft ADaM 2.1 document touches on this question a bit, but not explicitly.




Thanks to Jack Shostak

ADaM Datasets VS SDTM Datasets:

SAS® Programming Guidelines

This paper presents a set of programming guidelines and conventions that can be considered in developing code to ensure that it is clear, efficient, transferable and maintainable. These are not hard and fast rules but they are generally accepted good programming practices. These techniques can be used in all types of SAS® programs, on all platforms, by beginners and experts alike.

SAS ® PROGRAM EFFICIENCY FOR BEGINNERS


Guidelines for Coding of SAS® Programs

David Franklin's SAS Tips

2009

November - Looping the loop with DO loops

October - The Use and Abuse of the NODUPKEY option in the SORT Procedure

September - Comparing all datasets in one directory against all the datasets in a second dataset, using CALL EXECUTE

August - Selecting data for a particular month

July - I am missing a '0' in front of my day value, can SAS still read it okay? (or can SAS read a text date of '6JUN2009' correctly)

June - Prefixing a value with '+' or '-'

May - Why use dataset variable labels?

April - More on using a FORMAT to merge data

March - Delete all datasets in a library, except ...

February - Getting rid of the message "NOTE: BASE data set does not exist. DATA file is being copied to BASE file."

January - SUM(OF variables)

2008

December - Making a copy of a SAS dataset, Part 2

November - How would I set only character or numeric variables of an observation to missing?

October - Making a copy of a SAS dataset, Part 1

September - Character to Numeric Conversion

August - Numeric to Character Conversion

July - How would I set all variables of an observation to missing?

June - Making a SAS Transport File

May - Creating a Batch File

April - Transposing the data and label

March - Get a listing of all the SAS programs for a particular directory

February - Enclosing a negative value within brackets

January - Stripping (text)

2007

December - The CALL MISSING Routine

November - The MISSING function

October - Renaming a SAS dataset variable

September - Since when does a null string have a length of 1?

August - I just received a dataset with the dates in dd/mm/yy format but I want them in mm/dd/yy format for my report

July - The COLLATE function

June - PROC MEANS vs PROC SUMMARY

May - What SAS modules are on your system, and how to work around those that are missing

April - Removing labels and formats from all variables inside a dataset

March - Deleting old datasets using a date

February - The trig functions

January - FLOOR, CEIL, ROUND and INT

2006

December - Creating a graph using ODS RTF

November - Using the DHMS function to create a datetime value

October - Using CARDS or DATALINES to input data

September - FORMCHAR

August - Does the string contain a number?

July - LOWCASE/UPCASE/PROPCASE

June - Why use DATA _NULL_

May - Does x+y = SUM(x,y), revisited

April - Six ways to make your program run faster

March - SQL and the CALCULATED keyword

February - TRIM and TRIMN

January - Four Common Ways to Merge Two Datasets

2005

December - The CANCEL option in the RUN command

November - The DIM function for repeating the same action of different variables

October - The COMPARE function

September - Getting the last word in a string using SAS or Excel

August - Using SASHELP.VMACRO to view your macro variables, and %SYMDEL to delete them

July - Deleting a SAS dataset, revisited

June - Using PROC CHART to do a quick frequency analysis

May - The Variance results from SAS and Excel are different!

April - Finding a duplicate key record, Part II

March - The 2005 Conference Season begins

February - Sometimes, overwriting a dataset does not replace it

January - How does SAS store your date and/or time?

2004

December - Does x+y = SUM(x,y)?

November - An example of some unexpected results

October - Does a macro variable exist in your program?

September - Adding a value to an existing format

August - Common Mathematical Operators

July - Getting the background color from an Excel Worksheet cell

June - BYTE/RANK (this is not eating a hamburger)

May - The 2004 Conference Season begins

April - Getting a Cell Comment inside an Excel Worksheet

March - Finding a duplicate key record

February - FIRSTOBS=, OBS=

January - A BAT to create a Backup of your file

2003

December - SAS and Excel do not compute the same quartile value

November - Using a format to group basic statistical analysis

October - Coding a missing value

September - Sometimes your System Command Call within SAS does not work

August - COMPRESS or COMPBL, that is the question

July - Placing Unique values from a dataset into a macro variable

June - Share your datasets with others, consider the SASViewer

May - INDEX, INDEXW and INDEXC

April - Deleting a SAS dataset

March - Helping a SORT run faster

February - To avoid confusion, define the variables you create in a datastep

January - Introduction/Have a notebook handy