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The DLP (Data LifeCycle Plan) guides an organization and serves as a blueprint for how to create every type of data across all therapeutic areas and functional specialties. Howard describes the DLP as "an overall document that says here are the things you need to think about." In some DLPs, there might be more than 15 chapters, each controlled by a group of domain experts. Standard operating procedures (SOPs) typically cover process. DLPs, in contrast, are technical specifications about what happens to the data. Both SOPs and DLPs should be subject to similar governance. The DLP creates a framework for discussions that do occur on their own, but it forces them to an earlier stage of the process. Source: http://www.clinpage.com/article/cdisc_for_skeptics/C9 Here's a sample chapter of a DLP for demographic data from Kestrel Consultants, Inc.

Setting The Record Straight: The Future of ODM, SDTM and CDISC November 05, 2008 By Rebecca Kush, Frank Newby, David Iberson-Hurst, & Amanda J de Montjoie, CDISC When rumors increase, and when there is an abundance of noise and clamor, believe the second report. Alexander Pope, 1688–1744 In recent weeks, there have been a number of rumors about the Clinical Data Interchange Standards Consortium CDISC standards and their continued use by the Food and Drug Administration (FDA). These whispers suggest that the Study Data Tabulation Model (SDTM) standard is being replaced and that the Operational Data Model (ODM) should no longer be used. The rumors have caused confusion at best and fear of standards abandonment at worst. This is a second report—an attempt to clarify what’s happened and how the industry should move forward. CDISC, to state the obvious, is a global standards organization. While the FDA plays a vital role in the drug development industry in the U.S., there are other ...

Define.xml which generally describes what are we submitting to FDA .. like case Report Tabulations ( SAS datasets in XPT format, annotated CRF’s and the variables (metadata)) in a machine readable format….. In simple words it is .....Data and Metadata in Machine-Readable Format. It is considered as the standard process for submitting metadata to FDA and other regulatory bodies….

Though there are other Coding dictionaries available along with MedDRA (ex: COSTART and WHOART ), MedDRA dictionary is typically used in the US for Adverse Events coding. AE\ MedDRA coding is not the SAS programmers work; it is usually done by medical coder or database programmer. Coding basically involves a process of finding a dictionary term that matches the verbatim term reported on the CRF , and getting the other related dictionary derived variables useful for the analysis like System Organ Class ( SOC ), Preferred Term ( PT ) and Lowest Level Term ( LLT ), etc. Some times this process may take more time than expected, because Misspellings and other differences would delay the process of coding. In that case, person responsible for coding has to look for the dictionary term that which is the best possible match from the MedDRA dictionary. So the question here comes is what SAS programmer can do in this process. Here is the Answer…. SAS programmer has to work hard to make...

ABSTRACT: Code review is an essential step in the development of concise and accurate SAS® programs. It is a required verification step in performing validation in a regulated environment. This paper will present techniques and a macro that can be freely downloaded to automate this task. The %coderev macro will perform many of the common tasks during a code review including: 1. Spell checking headers and comments 2. Reviewing all input and output datasets of the program 3. Comparing defined macro variables versus macro variable usage 4. Checking for multiple macro calls that are not in a macro library 5. Evaluating hard code logic 6. Evaluating sort order of all datasets These tasks are normally performed by an independent reviewer instead of the original programmer. By automating the tasks, the code review process will ensure that the smallest mistake can be captured through reports to ensure the highest quality and integrity. What normally is a dreaded task can now be done with ease....

SAS Instructor Tip: Programming Featured Instructor: Cynthia Johnson How do I combine my SAS data sets and eliminate duplicate rows at the same time? SAS Instructor Cynthia Johnson responds ... SAS Instructor Tip: Programming Featured Instructor: Kent Reeve What happens when you forget the period on an informat when using formatted input? SAS Programming Tips[1] SAS/GRAPH Tip: Controlling the Graph Axis SAS Instructor Cynthia Zender shows you how to control the graph axis through a feature of using the AXIS statement. SAS ODS Tip: Creating Page X of Y Page Numbers SAS Instructor Cynthia Zender shows you how to use the SAS ODS ESCAPECHAR to create a "Page X of Y Page Numbers" SAS ODS Tip: Creating a Table of Contents SAS Instructor Cynthia Zender shows you how to create a table of contents using the CONTENTS= Option with ODS RTF and ODS PDF destinations. SAS ODS Tip: Controlling the Width of Cells SAS Instructor Cynthia Zender sh...

Listen to the SAS lecture series by http://www.sas.com/ to find out whats new in SAS 9.2 version..... SAS Lecture series for SAS 9.2 changes and enhancements for Base SAS has 3 sessions: Session 1: New and enhanced Procedures and Statements Overview of Changes and Enhancements DATA step Changes and Enhancements Base Engine Changes and Enhancements New Base Procedures Base Procedures Changes and Enhancements Session 2: The SAS Macro Facility Session 3: SAS XML LIBNAME Engine and ODS Listen to e-Lecture ---Then Note: e-lecture is on Session 1 only.. SAS Documenatation: What's New in SAS 9.2