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CLINICAL ANALYTIC SOFTWARE SOLUTIONS SAS SOFTWARE DEVELOPMENT AND CONSULTING BIOTECH PHARMACEUTICAL EXPERTISE SAS CFR PART 11 COMPLIANCE EFFECIENCY ACCURACY EXPEDIENCY
Training
 
Managing Thesaurus Dictionaries 
Coding Methodologies with MedDRA and WHO Drug
Live Web Training
Course Introduction
This course will walk you through the process of coding adverse event terms and drug names.  Some of the topics covered include:  optimize dictionary, auto coding, managing multiple dictionaries, searching for terms, build knowledge base, optimized coding decisions and create new mapped data.

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Prerequisites
The following software is required prior to attending the class. Some of the software will be supplied by the instructor while others is required on the student's machine.

Student's Requirements

  • Windows XP 
  • Internet Explorer or Mozilla Firefox 
  • Microsoft Office: Word and Excel 

Download Available

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: Tour of Sy/Map

  • Log into the system at: Sy/Map
  • Use the user name and password that has been emailed to you.
  • Review the screens under: Administration, Study Design and Study Conduct.

Exercise 2: Dictionary Management

  • Add a New Fictitious Dictionary

    • Sample Location:
      C:\Apache\htdocs\thesearch\testing\data

    • Data Name: SOC
    • Classification: MedDRA
    • Level: External
  • Modify Newly Created Dictionary
  • Delete Sample Dictionary

Exercise 3: Dictionary Management

  • Apply a search for an internal and external search of WHO and MedDRA dictionary.
  • Creating a sample mapping session for WHO
    • Select two sample source dictionaries
    •  Select one destination dictionary
    • Type sample path c:\Global\Project1\Study1\Source Data
    • Drug variable name: drgname
    • Patient ID: patienti
    • Indication Variable: indicat
    • Route Variable: route
  • Update information and then delete mapping session.

Exercise 4: Coding Drug Names and Adverse Events

  • Perform a sample Autocode for Study 1 
  • Performing manual coding
  • Performing exception mapping
  • Perform manual coding for WHO and MedDRA

Exercise 5: Splitting Terms and Reports

  • Splitting an AE and Conmed term
  • Review Reports for Coding Terms
    • Tentatively Mapped Terms
    • Exceptions Mapped Terms
    • Mapping History
    • Unmapped Verbatim Terms by Patient ID

Exercise 6: Creating Mapped Data and Review

  • Performing "Mapex" creating a dataset with coded terms.
  • Viewing and reviewing data
  • Create Trivial Words



 
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