A HOW-TO GUIDE FOR EXTENDING CONTROLLED TERMINOLOGY USING SAS CLINICAL DATA INTEGRATION
A HOW-TO GUIDE FOR EXTENDING CONTROLLED TERMINOLOGY USING SAS CLINICAL DATA INTEGRATION MELISSA R. MARTINEZ Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. AGENDA • • • • • What is Controlled Terminology? Adding a New CDISC Controlled Terminology Version Extending CDISC Controlled Terminology Codelists Customizing Controlled Terminology for a Study External Data Dictionaries Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 2 WHAT IS CONTROLLED TERMINOLOGY? CDISC definition: Set of standard value lists that are used throughout the clinical research process Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 3 WHAT IS CONTROLLED TERMINOLOGY? Set of possible values for your study within a codelist Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 4 WHAT IS CONTROLLED TERMINOLOGY? Set of possible values for your study within a codelist Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 5 WHAT IS CONTROLLED TERMINOLOGY? WHO Drug Dictionary – Dictionary of medicinal product information Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 6 WHAT IS CONTROLLED TERMINOLOGY? MedDRA - Validated medical terminology Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 7 A NOTE BEFORE DISCLAIMER ALERT PROCEEDING Please read full paper for complete details, available in the conference proceedings. Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 8 A NOTE BEFORE DISCLAIMER ALERT PROCEEDING Please read my full paper for complete details, available in the conference proceedings. This paper was developed for Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 9 FOUR WAYS OF EXTENDING CONTROLLED TERMINOLOGY Copyright © 2013, SAS Institute Inc. All rights reserved. External Data Dictionary Add New Version Customize Extend Codelist This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 10 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Add New Version Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 11 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION WHY? CDISC releases new versions frequently Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 12 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION WHY? CDISC releases new versions frequently Too long until planned CDI upgrade Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 13 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION WHY? CDISC releases new versions frequently Too long until planned CDI upgrade Take advantage of new terms Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 14 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 15 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 16 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 17 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 18 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 19 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 20 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 21 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 22 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 23 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 24 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 25 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 26 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 27 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 28 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 29 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 30 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 31 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 32 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 33 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RAW CDISC CONTROLLED TERMINOLOGY FILE This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 34 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RESTRUCTURED CDISC CONTROLLED TERMINOLOGY This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 35 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. RESTRUCTURED CDISC CONTROLLED TERMINOLOGY This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 36 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION Copyright © 2013, SAS Institute Inc. All rights reserved. REGISTER AND IMPORT NEW CONTROLLED TERMINOLOGY VERSION • Update standardsubtypes data set This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 37 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION REGISTER AND IMPORT NEW CONTROLLED TERMINOLOGY VERSION • Update standardsubtypes data set See Paper! Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 38 ADDING A NEW CDISC CONTROLLED TERMINOLOGY VERSION REGISTER AND IMPORT NEW CONTROLLED TERMINOLOGY VERSION • • Copyright © 2013, SAS Institute Inc. All rights reserved. Update standardsubtypes data set New CDISC Controlled Terminology version available in the Data Standards Import Wizard This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 39 EXTENDING CDISC CONTROLLED TERMINOLOGY CODELISTS Extend Codelist Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 40 EXTENDING CDISC CONTROLLED TERMINOLOGY CODELISTS WHY? Some codelists are extensible so that sponsors may add new, non-duplicate values Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 41 EXTENDING CDISC CONTROLLED TERMINOLOGY CODELISTS WHY? Some codelists are extensible so that sponsors may add new, non-duplicate values Add custom terms needed for a study Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 42 EXTENDING CDISC CONTROLLED TERMINOLOGY CODELISTS WHY? Some codelists are extensible so that sponsors may add new, non-duplicate values Add custom terms needed for a study Incorporate standard terms from a newer CDISC terminology release Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 43 EXTENDING CDISC CONTROLLED TERMINOLOGY CODELISTS EXAMPLE: FRM CODELIST • • Copyright © 2013, SAS Institute Inc. All rights reserved. Pharmaceutical Dosage Form Study Drug is a Caplet This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 44 EXTENDING CDISC CONTROLLED TERMINOLOGY CODELISTS Copyright © 2013, SAS Institute Inc. All rights reserved. HOW-TO • Make a new folder for the extended controlled terminology data set This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 45 EXTENDING CDISC CONTROLLED TERMINOLOGY CODELISTS HOW-TO • • Copyright © 2013, SAS Institute Inc. All rights reserved. Make a new folder for the extended controlled terminology data set Insert new terms using data step programming This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 46 EXTENDING CDISC CONTROLLED TERMINOLOGY CODELISTS HOW-TO • • • Copyright © 2013, SAS Institute Inc. All rights reserved. Make a new folder for the extended controlled terminology data set Insert new terms using data step programming Register the new controlled terminology data set in standardsubtypes dataset This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 47 EXTENDING CDISC CONTROLLED TERMINOLOGY CODELISTS HOW-TO • • • Make a new folder for the extended controlled terminology data set Insert new terms using data step programming Register the new controlled terminology data set in standardsubtypes dataset See Paper! Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 48 EXTENDING CDISC CONTROLLED TERMINOLOGY CODELISTS HOW-TO • • • • Copyright © 2013, SAS Institute Inc. All rights reserved. Make a new folder for the extended controlled terminology data set Insert new terms using data step programming Register the new controlled terminology data set in standardsubtypes dataset Import controlled terminology into CDI This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 49 CUSTOMIZING CONTROLLED TERMINOLOGY FOR A STUDY Customize Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 50 CUSTOMIZING CONTROLLED TERMINOLOGY FOR A STUDY WHY? Codelists should contain only possible values for a study Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 51 CUSTOMIZING CONTROLLED TERMINOLOGY FOR A STUDY WHY? Codelists should contain only possible values for a study Catch invalid values accurately with compliance checks Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 52 CUSTOMIZING CONTROLLED TERMINOLOGY FOR A STUDY WHY? Codelists should contain only possible values for a study Catch invalid values accurately with compliance checks Create a better, more accurate define.xml Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 53 CUSTOMIZING CONTROLLED TERMINOLOGY FOR A STUDY Copyright © 2013, SAS Institute Inc. All rights reserved. EXAMPLE: COUNTRY CODELIST This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 54 CUSTOMIZING CONTROLLED TERMINOLOGY FOR A STUDY Copyright © 2013, SAS Institute Inc. All rights reserved. HOW-TO • Make a new folder for the study-specific controlled terminology data set This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 55 CUSTOMIZING CONTROLLED TERMINOLOGY FOR A STUDY HOW-TO • • Copyright © 2013, SAS Institute Inc. All rights reserved. Make a new folder for the study-specific controlled terminology data set Remove unneeded terms using data step programming This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 56 CUSTOMIZING CONTROLLED TERMINOLOGY FOR A STUDY HOW-TO • • • Copyright © 2013, SAS Institute Inc. All rights reserved. Make a new folder for the study-specific controlled terminology data set Remove unneeded terms using data step programming Register the study-specific controlled terminology data set in standardsubtypes dataset This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 57 CUSTOMIZING CONTROLLED TERMINOLOGY FOR A STUDY HOW-TO • • • Make a new folder for the study-specific controlled terminology data set Remove unneeded terms using data step programming Register the study-specific controlled terminology data set in standardsubtypes dataset See Paper! Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 58 CUSTOMIZING CONTROLLED TERMINOLOGY FOR A STUDY HOW-TO • • • • Copyright © 2013, SAS Institute Inc. All rights reserved. Make a new folder for the study-specific controlled terminology data set Remove unneeded terms using data step programming Register the study-specific controlled terminology data set in standardsubtypes dataset Import controlled terminology into CDI This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 59 EXTERNAL DATA DICTIONARIES External Data Dictionary Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 60 EXTERNAL DATA DICTIONARIES WHY? Perform one more quality check on data values through compliance checks Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 61 EXTERNAL DATA DICTIONARIES WHY? Perform one more quality check on data values through compliance checks Ability to use several different data dictionaries Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 62 EXTERNAL DATA DICTIONARIES WHY? Perform one more quality check on data values through compliance checks Ability to use several different data dictionaries Ability to use several versions of a dictionary Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 63 EXTERNAL DATA DICTIONARIES Copyright © 2013, SAS Institute Inc. All rights reserved. EXAMPLE: MEDDRA This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 64 EXTERNAL DATA DICTIONARIES HOW-TO • Copyright © 2013, SAS Institute Inc. All rights reserved. Convert raw data file to SAS data set This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 65 EXTERNAL DATA DICTIONARIES HOW-TO • • Copyright © 2013, SAS Institute Inc. All rights reserved. Convert raw data file to SAS data set Register table in CDI This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 66 EXTERNAL DATA DICTIONARIES HOW-TO • • Copyright © 2013, SAS Institute Inc. All rights reserved. Convert raw data file to SAS data set Register table in CDI This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 67 EXTERNAL DATA DICTIONARIES HOW-TO • • • Copyright © 2013, SAS Institute Inc. All rights reserved. Convert raw data file to SAS data set Register table in CDI Add to a terminology package This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 68 CONCLUSION Copyright © 2013, SAS Institute Inc. All rights reserved. External Data Dictionary Add New Version Customize Extend Codelist This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 69 CONCLUSION • • • Increase data quality in submission data sets Make define.xml file more complete and accurate Please read full paper for complete details, available in the conference proceedings Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. 70 MELISSA R. MARTINEZ SAS INSTITUTE, INC. [email protected] Copyright © 2013, SAS Institute Inc. All rights reserved. This information is confidential and covered under the terms of any SAS agreements as executed by customer and SAS Institute Inc. www.SAS.com
© Copyright 2024