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CDISC SDTM Implementation Real World Application
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Course Introduction
Implementation of the CDISC data models is no longer a theoretical academic exercise but is now entering the real world. This course will walk you through the lessons learned from implementations of CDISC SDTM version 3.1.1 and ADaM 2.0. It will cover both technical challenges along with methodologies and processes.
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Student's Software  Requirements

  • Windows XP 
  • Internet Explorer or Mozilla Firefox 
  • SAS version 8.12 or higher 
  • Microsoft Office: Word and Excel 

Software Download 

Course Content

Instructor Contact

Sy Truong

email:
Yahoo ID:
mobile:
Office:
sytruongus
510 396 3464
408 955 9333

 

 Exercises
The following exercises accompany the course.  It is required that the course files are downloaded and uncompressed to your local hard drive.  You also need to have installed all the prerequisite software.

Exercise 1: Define Scope

  1. Review Sample - Open the "scope.doc" file located in your set of course files.  Review the types of items in the scope for a general understanding.
  2. Develop New Scope - Type up a scope document of your project.
  3. Submit Work - Email completed document to instructor.

Exercise 2: Identifying Tasks

  1. Review Sample - Open the file "identify_tasks.doc" located at in your set of course files.  Review to see how it is related to your project.
  2. Update Tasks - Update the task list to fit your project.  Have at least 10 distinct tasks.
  3. Estimate Time - Update the units to days and estimate the number of days it would take.
  4. Assign Resources - Assign to appropriate team members who will be working on this. 
  5. Submit Work - Email completed document to instructor.

Exercise 3: Risk Assessment

  1. Review Sample - Review the "risk_assessment.doc" document.
  2. Assess Three Risks - Select three types of tasks that are involved in your data transformation.  Try to select high, medium and low risk.  Cut and paste the form tree times.  Perform the risk using this form.
  3. Summarize Risk - Sum up the score and classify the task using the scale: 
    Low 15-30
    Medium 31-45
    High 46-60
  4. Submit Work - Email risk assessment and score to the instructor.

Exercise 4: Test Plan

  1. Review Sample - Review the sample test plan  "test_plan.doc" and test script "test_scripts.doc" document.
  2. Edit Test Scripts - From the three items identified within the risk assessment, edit the test script to perform the three tests.  Update the section titles and the table of contents.
  3. Submit Work - Email the complete test script to the instructor.

Exercise 5: Transformation Specification

  1. Review Sample - Review the two datasets AE and DEMOG located in the data folder.  Review the spreadsheet "transformations_spec.xls".  Review the Guidelines "SDTM--3.1.1ImplementationGuide.pdf".
  2. Update Specification - Update the spreadsheet specification per the sample data and from the guidelines for AE and DEMOG.
  3. Submit Work - Email the complete transformation specification to instructor.

Exercise 6: Program Transformation

  1. Create New Model - Create a new study and a model in it.  Create model for AE and DEMOG with Transdata.
  2. Edit Model - Edit the model specifying some of the transformation that was specified in specification document.
  3. Generate Code - Generate transformation Code.
  4. Apply Transformation - Apply Transformation by running programs.

Exercise 7: Verification Report

  1. Generate Report - Generate reports for "Print Model", "Verification Reports", Find Duplicates" and "Contents".
  2. Search Transformation - Apply Search for transformation specification items.
  3. Submit Work - Email the verification reports and search results to instructor.

Exercise 8: Supplemental Qualifiers 

  1. Review Guidelines - Review "SDTM--3.1.1ImplementationGuide.pdf" guidelines on supplemental qualifiers.
  2. Generate SUPPQUAL - Generate the SUPPQUAL dataset using CDISC Builder
  3. Submit Work - Email SUPPQUAL dataset to instructor.

Exercise 9: CO and RELREC 

  1. Generate CO and RELREC - Generate the CO and RELREC dataset using CDISC Builder
  2. Submit Work - Email CO and RELREC datasets to instructor.

Exercise 10: Sequence 

  1. Generate SEQ for AE -Generate sequence variable AESEQ for AE data.
  2. Submit Work - Email updated AE dataset to instructor.

Exercise 11: Variable Length 

  1. Update Length - Update length for AE and DM datasets.
  2. Submit Work - Email updated AE and DM datasets along with reports to instructor.

Exercise 12: Data Definition Documentation 

  1. Generate DEFINE.PDF/XML - Generate the domain data definition documentation for AE and DM using Definedoc.
  2. Generate DEFINE.XLS - Export information to Excel and re-import.
  3. Submit Work - Email updated DEFINE.PDF and XLS to instructor.

Exercise 13: Annotated CRF  

  1. Generate Template - Generate an Annotated CRF template from Definedoc.
  2. Annotate Sample CRF -Annotate sample CRF.
  3. Submit Work - Email new annotated CRF Word document to instructor.

 


 
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