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Chat Room Questions & Answers from May 12, 2009

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  • Chat Room Questions & Answers from May 12, 2009

    Q1: Is Report validated under SAS 9.2?

    A1: Yes, it was written and validated under SAS 9.2.

    Q2: Do you need to recreate the Listings that you made in the Listings area in order to use them for the Patient Profiles?

    A2: Yes, Patient Profile Sections differ internally from standard listing templates so there is a need to recreate the listings from the Patient Profile Template Builder module. A future enhancement may address converting standard listings to profile sections.

    Q3: Can you merge datasets to produce listings and do simple statistics?

    A3: The ClinPlus Report system is a report authoring tool that expects data to be report ready. Any data manipulation (merging, variable derivations, etc.) must be done using a pre-processing program. The pre-processing program is a SAS program that can be created and modified directly from the template builder. Our optional ADaM Conversion Toolkit and Template Library includes all pre-processing programs required by the template library.

    Q4: Can this tool be used to generate all the ADaM domains? If not, how many domains can be generated?

    A4: These are the ADaM domains that are included:
    - Demographics
    - Subject Status
    - Adverse Events
    - Concomitant Medication
    - Medical History
    - ECG
    - Physical Measurements
    - Physical Exams
    - Vital Signs
    - Lab

    Templates for safety tables and listings are included for each domain.

    Q5: Can the ADaM listing be modified?

    A5: Yes, all ADaM listings and tables can be modified by either adjusting the metadata specific to each template or modifying the template itself. Additional safety and efficacy templates can be added as needed using the template builder.

    Q6: What is included with Report and Report Lite?

    A6: ClinPlus Report Lite includes the Listing Template Builder, Patient Profile Template Build plus all administrative tools. In other words, it includes everything except the Table Template Builder. The ADaM Conversion Toolkit and Template Library is a separate add-on to ClinPlus Report.

    Q7: How can we receive the beta version of Report or Report Lite?

    A7: Current ClinPlus Report users will be receiving the new version at no cost under the maintenance agreement. Others may request the beta version on a no-cost trial basis. You may contact Patrick Champoux at 1-866-254-6758 ext. 146, [email protected] to arrange the installation.

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    Last edited by Ronni Rubenstein; 05-14-2009, 08:57 AM.