Metadata
SapMaker Metadata 2.3
User Guide
ClinTrialStat Inc
What is SapMaker Metadata?
SapMaker Medadata 2.3 is a tool to efficiently make metadata documents of Statistical Analysis Plans (SAP) for clinical trials. It will automatically create metadata of SAS dataset, create metadata for converting SAS dataset to CDISC STDM or AdaM dataset, create SAS template for converting the SAS datasets, and convert metadata to define.xml document.
Who should use SapMaker
Metadata 2.3?
Biostatisticians, Data Managers, and Statistical Programmers who are working on clinical trials.
Features
¡¤ Automatically create metadata document of a SAS dataset in a Microsoft Word and/or Excel document.
¡¤ Automatically create SAS program template for creating a dataset based on the metadata document (in an Excel document).
¡¤ Automatically compare metadata of a SAS dataset with metadata standards of an organization to help user to modify the SAS dataset to meet the standards.
¡¤ Automatically create metadata document for helping user to convert SAS dataset to the standards of the Clinical Data Interchange Standards Consortium (CDISC) included Operation Data Model (ODM), Study Data Tabulate Model (SDTM), and Statistical Analysis Dataset Model (ADaM) based on Allow users to work on metadata in Excel spreadsheets and then convert to a XML metadata document following CDISC standards.
¡¤ Automatically transfer customer's metadata for submission to define XML metadata document following CDISC standards.
Requirements
¡¤ Supported Operating Systems: Microsoft Windows 9X/NT/2000/XP (Windows 9X/NT/2000 need to be updated with NET. Framework)
¡¤ Software Requirements: Microsoft Word and/or Microsoft Excel.
Table
of Contents
Features and Icons of SapMaker
Metadata
Overview of Panels of SapMaker Metadata Window 2.3
Overview Creating Metadata Documents of the Statistical
Analysis Plan
Retrieve Metadata from Metadata
convert into XML File.
Open
Files Storing Metadata Standards
Select
Variables from Primary and Secondary Metadata Panels
Create
Metadata Document in Excel Document
Create
Metadata Document in Word Document
Based on Metadata Document to
Generate SAS Program Template for Creating SAS Dataset
Create Metadata Document of SAS
Dataset
Convert Metadata Document to XML Document following
Standards of CDISC
Features and Icons of SapMaker Metadata
SapMaker Metadata Window 2.3 provides its users with twenty-seven features to efficiently document metadata of datasets of a clinical study. Eleven comment features are associated with an icon which when clicked executes the desired feature. These icons are presented in the menu bar of the SapMaker Metadata Window as shown in Figure 1. When an icon is double clicked, the action associated with the icon or the feature will be executed. The icons and its associated features are summarized in Figure 2.
¡¡
Figure 1. Icons in menu bar
Figure 2. Icons of SapMaker and Associated Features
|
Icon |
Action |
Feature |
|
|
Opens a dialog window to setup information of a
study (e.g., protocol number, study name, etc.) for a SapMaker project. |
|
|
|
Open Project |
Open an existing project information ((e.g.,
protocol number, study name, etc.) |
|
|
Save Project |
Save current project to the project profile file. |
|
|
Get SAS Dataset Metadata |
Read a SAS dataset to retrieve its metadata into
the software for documentation. |
|
|
Get Metadata in Excel File |
Open Excel file to retrieve the metadata save in it
into the software for documentation. |
|
|
Get CDIS Standards |
Retrieve metadata standards of CDISC into the
software for documentation. |
|
|
Get Customer Metadata Standards |
Retrieve metadata standards of users into the
software for documentation. |
|
|
Select Item |
Select metadata items and edit them to either meet
standards or create new metadata. |
|
|
Write Metadata Document in Excel |
Write edited metadata items to an Excel document.
|
|
|
Write Metadata Document in Word |
Write edited metadata items to a Word document. |
|
|
Scan SAS Dataset for Metadata |
Scan a SAS dataset to created a metadata
document for the dataset. |
|
|
Exit Project |
Exit SapMaker project, quit SapMaker,
and close related windows |
Quick Start of SapMaker Metadata 2.3
Step 1: Start Application
First click the SapMaker Metadata 2.3 icon to start
it:
Step 2: Retrieve Metadata of SAS Dataset
Then select the option Metadata
Retrieve Metadata 
from SAS Dataset from the
top menu bar
You will see an open-file dialog window like the one
in the following figure, which will let you select a SAS dataset
Once you highlight the SAS dataset name, click the Open button; the name and label of the variables from the SAS dataset will be listed on the top panel of the tool.
Step 3: Get CDISC Standards
Select the option Metadata
Select Metadata Standards 
from CDISC STDM/ADaM from the
top menu bar.
You will then see a group of CDISC domain
names and labels listed in the middle panel of the tool. When you double click
the domain name ¡®DM:
Demographics¡±, the name of the variables from the CDISC DM domain
(demographics) will be listed.
Step 4: Map to Metadata Standards
To map variables from the retrieved SAS data to CDISC
STDM/AdaM standard variables, first choose Selection 
Match Metadata Standard 
by Name or Label option, SapMaker
Metadata will compare metadata of each variables from the retrieved SAS dataset
listed in the top panel with standard variables of CDISC in the middle panel,
and map metadata matched pairs of variables on the bottom panel.
.
Step 5: Create Metadata Document in Excel Document
In this step you will create the metadata document that maps the
retrieved SAS dataset to CDISC standards in an Excel spreadsheet by either
selecting the menu button Document
Metadata In Excel Document (as
following figure), or by double clicking the 
icon
:
The metadata document created in Excel document is as follows:
You can repeat steps 1 thru 5 to create metadata documents for mapping other SAS datasets to CDISC standards. The newly created Excel spreadsheet will be automatically named as ¡°Domain Metadata¡± in the ¡°C:\SapMaker Project\doc¡± subdirectory.
You can further continue work on this metadata documents such, as Comment column until it is ready to be converted to a define.xml document.
Step 6: Convert Metadata Document in Excel Document to Define.XML
When you
have finalized the metadata document in Excel, you can convert the metadata to
a XML document define.xml based on the standards of CDISC.
To do so, you must first select the menu button XML 
Insert Study metadata to Excel File. This action will insert a sheet that holds study metadata
needed by define.xml document. Then
you will select the menu button XML Convert to define.xml File / Validate XML that will first check whether the texts in Excel metadata
document are validated XML texts. (For example, text & is not a validate
text for attribute of XML document.)
Then it will create the define.xml document if the all contents of
Excell metadata document are validated XML texts. You can
also select menu button XML Convert to define.xml to create define.xml file, in which the
texts will be validated.
When a define.xml file is created, SapMaker will give a message. Following is an example of created define define.xml file:
Overview
of Panels of SapMaker Metadata Window 2.3
SapMaker
Metadata Window 2.3 provides its users with five panels for helping them efficiently
create metadata documents of a Statistical Analysis Plan. These panels are
presented in the following figure. Their functions are described in the
following paragraphs.
Project Explorer Mapped Metadata Panel Standard Metadata Panel Primary Metadata Panel
Secondary Metadata Panel
- Project Explorer panel:
Project Explorer panel lets users to manage metadata documents.
- Primary Metadata panel: the
Primary Metadata panel lets users to list variable name and label of a
dataset (referred to as the primary dataset).
- Secondary Metadata panel: the
Secondary Metadata panel lets users to list variable names and labels of
another dataset (referred to as the secondary dataset) so that the user
select variables from both listed in the Primary Metadata panel and
Secondary Metadata panel to create a new variable and list it in the
Mapped Metadata panel.
- Standard Metadata panel (left middle panel): the
Standard Metadata panel let users to list variable name and label from a
domain specified in CDISC or customer created standard metadata document
(referred to as reference dataset).
- Mapped
Metadata panel: the Mapped Metadata List panel stores variables selected
from the primary dataset and/or from the secondary dataset to include in
the selected metadata document.
Overview of SapMaker Project
To organize documents created by SapMaker Metadata
such as Word or Excel documents for metadata of analysis datasets, SapMaker
Metadata will store these documents into a SapMaker Project folder. This
project folder is called SapMaker Project. It has three sub-folders, doc, log,
and prog. The doc subfolder will store Word and/or Excel metadata documents,
and the log sub-folder will store the location of the project folders. SapMaker
Metadata will automatically create these folders when the user clicks
the menu button ProjectNew or double clicks the 
icon ¡¡
SapMaker Metadata Project Folders
¡¡
Project Explorer¡¡
The Project explorer window will
help users to manage the process of creating a metadata documents for a
Statistical Analysis Plan (see Figure 1).
Users can browse these folders
within the Project Explorer window. They can restart work on a
metadata document previously saved by clicking the name of the document in the
Project Explorer window. SapMaker Metadata will open the document
and automatically add new materials to the document.
Project Explorer
Start New Project¡¡
To start a new project you must first setup a SapMaker
Project folder to save the documents into. The newly created documents will
then be saved into the three subfolders doc, log, and prog. The doc sub-folder
will store Word and/or Excel metadata Sap documents, and the log sub-folder
will store information about the project folder. When you start a new project,
SapMaker Metadata will automatically create the SapMaker Project folder and the
three subfolders doc, log, and prog. To start a new project, select the
menu button ProjectNew or double click the 
icon.
This action will trigger SapMaker to pop up a dialogue window allowing the user
to browse the directories for creating the SapMaker Project folder and its
subfolders.
Popup select folder dialogue window for browsing directories
Once user
has selected a working folder, a dialog window will pop out to let the user to
input information of study such as protocol number, study name, and treatment
groups.
Popup project information dialogue window for project global
information
Open Project
You can call back a previously saved SapMaker project by
opening the folder for the project. The documents created before will be
presented in the Project Explorer window. You can then double click a
document listed in the Project Explorer window to continue to add additional
content into it. To do so, you can either select the menu button Project
Open or double click the 
icon, which will lead to a pop up of an open-file dialogue
window so that you can browse the directories to locate the folder in which
the documents were stored (see Figure 2).
Open project
Open-file dialogue window for
browsing the project folder
This will
trigger a dialog window that will retrieve information of study (e.g., protocol
number, study name, treatment groups, etc.) saved in the project log file.
Saving Project
Before exiting SapMaker, you can
save treatment groups, project folders, or the directory of a customized
templates of your organization into a file stored in the log
subfolder. The next time you comes back to SapMaker, the saved the
project folders can then be recalled into SapMaker Metadata. To do so the you
can either select the menu button Project
Save, or Project
Save As or click the 
icon, which will lead to a popup save file dialogue window so
that you can choose a file name in the log subfolder of the project to store
the project folder information.
The data of your project were stored into a XML document.
Save project
Save file dialogue window for browsing the project folder
Modify Project
After starting the project, you can modify the set up of the
study by selecting the menu button Project
Modify, which will pop up the dialog
window for you to modify the study information.
.
Exit Project
After saving the project, you can exit SapMaker Metadata by
selecting the menu button Project
Exit or click the 
icon, which will close any Word or Excel documents opened by
SapMaker Metadata and quit SapMaker Metadata.
Overview Creating Metadata Documents of the Statistical
Analysis Plan¡¡
SapMaker Metadata will help users to
document metadata (definition of datasets and variables) of SAS datasets in
Excel or Word documents by simple open the SAS dataset from within the
produce. (Or open an Excel
document holding definition of data tables and variables traced from Oracle
database as soon as the Data Base Manager (DBM) has set up Oracle tables
instead of waiting real data to create SAS dataset.) This tool can
help users to create metadata document for instructions to SAS programs of how
to create analysis SAS datasets and derived variable. The tool can help users to compare the metadata of the
SAS dataset with CDISC ODM/STDM/ADaM metadata standards and
then help the users to write specifications about how to convert
the SAS dataset to CDISC submission data models. If
the users keep using this tool to prepare their own studies¡¯ metadata documents
(i.e., which variables are original from Case Report Form (CRF) and which
are derived ones), the product would auto-create tracing information about how each
of the derived variables were created from original CRF variables.
Open Primary Dataset
To start working on metadata document, a user has to first
open a dataset and then drag its variable names into the Primary Metadata
panel. To load metadata in the primary dataset into SapMaker Metadata, the user
needs to select option Metadata
Retrieve Metadata, and select an
appropriate choice: from SAS
Dataset, from Metadata Excel File by SapMaker Format, from SapMaker documented
Metadata Excel File, and from Metadata convert into XML File. The detailed steps for using
each of these options are discussed as follows.
Open Metadata dialogue window for
retrieving metadata of datasets
Retrieving
Metadata from SAS Dataset for the Primary Dataset Metadata
When you selected this option, it will lead to a popup open file dialogue window so
that you can browse your computer network and choose a SAS dataset file name
and open it.
This name and label of variables of the opened primary dataset will be listed into the Primary Metadata List panel.
Retrieving
Metadata from SAS Dataset for the Primary Dataset
Metadata
When you selected this option, it will lead to a popup open file dialogue window so
that you can browse
Retrieving
Metadata from Excel Files in SapMaker Format:
This option allows you to retrieve metadata stored in an Excel document. The stored metadata include definitions
of data tables and variables traced from Oracle database. These metadata will be available as
soon as the Data Base Manager (DBM) has set up Oracle tables instead of waiting
for the real data having been collected and converted to SAS dataset.
The data items put into
the Excel document should be saved in a sheet named as ¡°DB Metadata¡± and should
have the following columns. The same column name (with the same case) as
presented should be used.
Column Name for ¡°DB
Metadata¡±:
DatasetName: name of dataset or Oracle table such as
AE, etc.
VariableName: name of
variables in the dataset such as USUBJID, etc.
VariableLabel: label of variables in the dataset such
as ¡°Unique Subject Identification¡±, etc.
SASType: type
of variables in the dataset such as CHAR, etc.
DBLength:
length of variables in the dataset such as $30, etc.
Codelist/Dictionary: name of code list or dictionary for
codes of variables
The code list or
dictionary items should be saved into another sheet called ¡°DB Code List¡±, and
it should have following columns.
Column Name for ¡°DB Code
List¡±:
CodeID:
identification of the code list
Description: description
of the code list
Code:
code per item per cell
Decode: decode per item per
cell
The two sheets ¡°DB Metadata¡± and ¡°DB
Code List¡± should be stored in one Excel file. Sample of the two Excel sheets are listed as follows.
Format of Excel sheets for storing metadata to be retrieved into
SapMaker Metadata
When users selected the option of Retrieve Metadata from Excel File by SapMaker Format, it will lead to a popup open file dialogue window so
that you can browse your computer network and choose an Excel file name and
open it. After you opened the
Excel file, the name of dataset will first be listed in a pop up dialog window
Then you
can select name of a dataset from within the dialog window and then click ¡°OK¡±
button. This will list the name and label of variables of the selected dataset
into the Primary Metadata panel.
(In following figure AE dataset was selected.)
Retrieve
Metadata from SapMaker Documented Metadata Excel File:
This option allows users to retrieve metadata created by SapMaker Metadata in an Excel
file. (Latter in this article we
will introduce one feature of SapMaker Metadata of scanning the SAS dataset and
documenting the metadata of the dataset into an Excel file.) This will save user time for
retrieving the metadata of a SAS dataset into SapMaker Metadata when these
metadata need to be used repeatedly.
When users need to document metadata of other new datasets using
currently developed metadata document, this feature will meet their needs.
Following figure show
metadata of a dataset documented in an Excel file. As shown in the figure, the format of this metadata
format follows the standard of Clinical Data Standards
Consortium (CDISC). (We
will discuss CDISC latter in this article.)
When you selected the option of Retrieve Metadata from SapMaker Documented Metadata Excel
File, it will lead to a popup open file dialogue window so
that you can browse the SapMaker Project doc folder to open the Excel file
¡°Domain Metadata¡± created by SapMaker Metadata and open it. After you opened the Excel file, the
name of datasets will be opened into a popup open dialog window (as shown in
the top of the page). When you
have selected the name of a dataset clicked the ¡°OK¡± button, the metadata of
the selected dataset will be opened to the Primary metadata panel.
Format of Excel sheet created by SapMaker Metadata for metadata
document of a dataset
Retrieve
Metadata from Metadata convert into XML File.
This option allows users to retrieve metadata converted to a XML file by SapMaker
following CDISC standards.
Open Secondary
Dataset
Users are able select metadata items
from more than one dataset at the same time, to do so you can open one dataset
onto the primary metadata panel and the other onto the secondary metadata
panel. Then pick up variables from the two datasets for creation of a metadata
document of the new dataset. To load metadata in the secondary dataset, the
user needs to select the option Metadata
Retrieve Another Metadata, and select
an appropriate choice: from Another SAS Dataset, from Another Metadata Excel
File by SapMaker Format, and from Another SapMaker documented Metadata Excel
File. The detailed steps of how to use these options are the same as the
ones discussed above. The
only difference is that the metadata of this additional dataset will be opened
to the secondary metadata panel as show in the following figure.
Secondary Metadata Panel
Open Files
Storing Metadata Standards
SapMaker Metadata allow users to
compare the definitions of their own variables with CDISC STDM/ADaM standards
or the metadata standards of users¡¯ organization, and then to created a
metadata document for instructions of how to convert variables into standard
ones. The steps are as
follows: First the users need to open metadata of their own dataset onto the
primary metadata panel. (Or open both the primary and secondary datasets if
more than one datasets are needed.)
Secondly the users need to open the standard metadata onto the standard
metadata panel. Then the
users can use the matching algorithm provided by SapMaker Metadata to map or
match their own variables to standard variables based on the variable name or
label. The users can also
pick up their own variables and map them to listed standard variables by
themselves. To load standard metadata into SapMaker Metadata, the user needs to
select option Metadata
Select Metadata Standards, and select
an appropriate choice: from CDISC STDM/ADaM Standards in XML, from User
Metadata Standards in XML, and from SapMaker documented Metadata Excel
File. The detailed steps for using each of
these options are discussed as follows.
Open File with CDISC Metadata Standards
Background: The marketing approval process for regulated human and animal health products often includes the submission of data from clinical trials. In the United States, this is a mandatory requirement of the Food and Drug Administration (FDA) as expressed in the Code of Federal Regulations (CFR). The FDA has worked with the Clinical Data Standards Consortium (CDISC) to standardize the content and structure of clinical trials data for regulatory submission. CDISC (www.cdisc.org) consists of more than 120 companies active in the research and development of regulated health-related products. CDISC is an associate organization of HL7 and has worked closely with HL7 to ballot the Clinical Trial Data Regulatory Submission Model (which is Version 3 of the CDISC Submission Data Domain Models). CDISC created standards for Operational Data Model (ODM), and Analysis datasets of Study Data Tabulate Model (SDTM) and Statistical Analysis Dataset Model (ADaM). These standards included metadata for Demographics, Adverse Events, Concomitant Medications, Study Disposition, Drug Exposure, Laboratory, ECGs, Medical History, Physical Exam, Vital Signs, Change from Baseline Data Analysis, categorical Data Analysis, Survival Data Analysis, etc.
When you selected the option of open
metadata standards from CDISC STDM/ADaM Standards in XML, it will lead SapMaker Metadata to list a group of data
domain names into the secondary metadata panel, and you have to pick up one
data domain by double click the name of you selected data domain.
After you have double clicked the name of you selected data domain, names of the variables of this data domain will be listed.
Open
User Metadata Standards from XML File
When you selected this option, it will lead to a popup open file dialogue window so
that you can browse your computer network and choose metadata standards of you
own organization converted to a XML document. (Latter we will discuss how to
convert user customized metadata in Excel document to XML file using SapMaker
Metadata.) After
you have chose the XML file, the remand steps are as those discussed in the
above section.
Open
User Metadata Standards from Excel File
When you selected this option, it will lead to a popup open file dialogue window so
that you can browse your computer network and choose metadata standards of you
own organization stored in an Excel document. This Excel document should has the following format:
After you have chosen the Excel file, it will lead to a popup open file dialogue window asking
you to provide the dataset name or the name of a spreadsheet in the opened
Excel file (e.g., demog, dispo, ae in the above figure).
Once you
have selected the dataset name and clicked O.K. button, the remand steps are
the same as those discussed in the above section.
Select Variables from Primary and Secondary Metadata
Panels
When you have opened datasets and listed names of variables
onto the primary and/or secondary metadata panels, and metadata standards to
the standard metadata panel, you can select variables from the primary and/or
secondary panels and modify them to a new variable match one listed in the
standard metadata panel. The new
variables will be mapped to the mapped metadata panel for the further creation
of metadata document of a new dataset.
To do so, you can select the option Selection, and then
select an appropriate choice of: Select and Map Items, Select Items, Match
to Metadata Standards (by Name and Label; by Name, by Label; by Name or Label;
and Map to Standard). The
detailed steps for using each of these options are discussed as follows.
Select and Map Items
This option let you directly map variables you highlighted
in the primary metadata panel to the mapped metadata panel. Then you can select document option to write these mapped
metadata into an Excel or Word document. To highlight variables, you can hold
the ¡°Shift¡± key in your computer keyboard and click the first variable and the
last variable you want to highlight. You can also hold the ¡°Ctrl¡± key in your computer
keyboard and click each variables want to highlight. Then you select the choice Select
Select and Map Items. This action will lead to a popup
open file dialogue window asking you to provide the name and label for the new dataset. Once you did it, variables you highlighted
in the primary metadata panel being moved to the mapped metadata panel.
Select Item
This option let you select multiple variables from one
dataset whose variables were listed in the primary metadata panel, and/or a
variable from the other dataset whose variables were listed in the secondary
metadata panel. Then you can
combine these selected variables together to form a new variable. For example, you can select the first
dose date (FDOSEDT) and reason of withdrew (DSREAS) from one dataset (DISPO)
and date when an adverse event occurred (AESTDT) that led to the termination
from another dataset (AE). You want to construct a new variable of the duration
of adverse event causing termination (AEDUR) for your new dataset KAE. You can use the Select Items /
Confirm Items choices to create a metadata item as:
Select
AE.AESTDT ¨C DISPO.FDOSEDT +1 as KAE.AEDUR, where DISPO.DSREAS =¡±Adverse Event¡±
To do so, you open metadata of datasets AE and DISPO in the
primary metadata panel and secondary metadata panel, respectively. Then you highlight AESTDT from the
primary metadata panel, and FDOSEDT and DSREAS from the secondary metadata
panel (hold ¡°Ctrl¡± key and click FDOSEDT and DSREAS), and highlight AEDUR from
the standard metadata panel. Then you select the ¡°Select Items ¡°
choice. This will open a pop up
dialogue window to let you to edit the metadata of new variable. You can edit the metadata in the dialog window. When you click ¡°Edit/Review¡± button then a clause will be inserted in to the text
box beside the button to allow you to edit it. Finally, when completed the editing, you can click ¡°OK¡±
button that will move you edited clause to the mapped metadata panel. The steps discussed above are visually
presented in the following figures.
Highlight variable names from primary, secondary, and standard metadata panels
Pop up dialog window to edit
metadata of new variable
Mapped metadata of new variable
after click ¡°OK¡± button
Match to Metadata Standards
This option let you directly match
variables listed the primary metadata panel to standard variables of either
CDISC STDM/ADaM data model or your own organization data model. (These metadata
standards are listed in the metadata panel.) When you choice Select
Match Metadata Standard and the select one of options of by
Name and Label, by Name, by Label, and by Name or Label, SapMaker Metadata will compare each of
variables in the primary metadata panel with standard variables in the
secondary metadata panel, and match one variable in the primary metadata panel
with one variable in the standard metadata panel if (1) both their name and
label are the same (option by Name and Label), (2) their name is the
same (option by Name), (3) their label is the same (option by Label),
(4) either their name or label is the same (option by Name or Label),
respectively.
After you conducted Match Metadata Standards process,
you can use Select Items option discussed above to map variables to
standards based on you own choice.
Map to Metadata Standards
This option let you directly map variables listed the
primary metadata panel to standard variables of either CDISC STDM/ADaM or your
own organization. (These metadata standards are listed in the metadata
panel.) When you choice Select 
Match Metadata Standard 
Map to Standard option, SapMaker Metadata will
compare each of variables in the primary metadata panel with standard variables
in the standard metadata panel, and map one variable in the primary
metadata panel with one variable in the standard metadata panel if either their
name or label is the same or only has one character difference.
Create Metadata
Document in Excel Document
When you have selected contents for a new metadata document,
you can create the new metadata document in an Excel Document by either
selecting the menu button Document
Metadata In Excel Document (as
following figure), or double click the 
icon:
The metadata document created in Excel document is as
follows:
Note: You should not close any Excel spreadsheet opened by SapMaker Metadata until you exist from SapMaker Metadata.
Create Metadata Document in Word Document
You can also create the new metadata document in a Word
Document by either selecting the menu button Document
Metadata In Word Document, or double
click the 
icon. The
metadata document created in Word document is as follows:
Note: You should not close the Word opened by SapMaker Metadata
until you exist from SapMaker Metadata
Based on Metadata Document to Generate SAS Program
Template for Creating SAS Dataset
This
option let you directly generate SAS program template for creating a SAS
dataset by using definitions of variables specified in the metadata document of
that SAS dataset. The metadata of
the SAS dataset should be written in an Excel document. The name, label, and
the length of each variable specified in the metadata document will be used to
write the SAS program template.
When you choice Document
SAS Template for Derived Dataset option,
it will lead
to a popup open file dialogue window so that you can browse your project folder
and open the Excel file that contains the metadata document for the SAS dataset
to be created.
Once
opened the Excel file, you need to select the name of the SAS dataset from a
popup dialog window and click the ¡°OK: button. Then the SAS template will be created and saved in the ¡±log¡±
sub-folder of the Project folder by a file name of K plus the name of the
dataset. (i.e., if the name of dataset is ¡°AE¡± then the name for the SAS
template is ¡°KAE¡±.)
The following two figures present
the metadata documented in Excel file and SAS program template created based on
the metadata.
Metadata documented in Excel File
SAS
Program Template Based on Metadata Document
Create Metadata
Document of SAS Dataset
This option let you directly generate metadata document of
existing SAS dataset. The metadata
can be written in an Excel document or a Word document. The name, label, code
(for categorical variable), number of records, and range of variables in the
SAS dataset will be written to the metadata document. When you choice Scan
Metadata of SAS Dataset to Excel Document
option, SapMaker Metadata will popup an open file dialogue window asking you to
provide the SAS dataset name and location as shown in the following figures.
The metadata document created in Excel document is as
follows
Note: You should not close the Excel opened by SapMaker Metadata until you exist from SapMaker Metadata
Convert Metadata Document to XML Document following
Standards of CDISC
CDISC Standards:
Metadata follow the standards of
CDISC for Operational Data Model (ODM), Analysis datasets of Study Data
Tabulate Model (SDTM), and Statistical
Analysis Dataset Model (ADaM) can be store in an Extensional Mockup
Language (XML) document. SapMaker Metadata has a
feature to convert the metadata documents written in
Excel or Word document to XML document that
matches the standards of CDISC.
Convert Excel Document Metadata to define.xml XML Document
When you have finalized the metadata document in Excel, you
can convert the metadata to a XML document define.xml based on the
standards of CDISC.
To do so, you first
need to add a sheet for holding study metadata to the Excel metadata document.
You can simple select the menu button XML Insert Study Metadata to Excel File to add the study metadata sheet. You then might need to modify the default metadata by actual
study metadata.
Inserted Study Metadata Sheet
You
will then to select the menu button XML Convert to define.xml File / Validate XML that will first check whether the texts in Excel metadata
document are validated XML texts. (For example, text & is not a validate
text for attribute of XML document.)
Then it will create the define.xml document if the all contents of
Excell metadata document are validated XML texts. You can
also select menu button XML Convert to define.xml to create define.xml file, in which the
texts will not be validated.
Select Menu to Convert Metadata to define.xml
After you have click the menu button, it will lead SapMaker Metadata to popup an open file dialogue window asking you to provide the name and location of the Excel metadata document to be converted. When you picked one, the name of each domain in the excel file will be listed in a popup dialog window (as shown in the following figures)
Browse folder for the Excel
spreadsheet file
List Name of Domains in Excel
Spreadsheet
Then you need to highlight domain
name to be converted to XML document, and click ¡°OK: option
to convert metadata of this highlighted domain to XML
document. Then you will also be asked for file name to save the converted
define.xml document.
When the Excel
metadata were converted to XML document, a dialogue window will appear to
inform you.
Converted XML
Metadata Document
View Converted XML
Metadata
View Recorder of SAS Dataset
This option let you directly view the recorders of an opened
SAS dataset. When opened a SAS
dataset, you can choice View
Data Recorder option. SapMaker Metadata will open a
data grid to list recorders in the SAS dataset (as shown in the following
figures).
When you choice View
Data Code option, SapMaker Metadata
will list the distinguished values for each categorical variable in the opened SAS
data (as shown in the following figures)
