Specifying a data and map file

To import a data and map file:

1. Do one of the following:
   • Create a map file to import.
   For more information, see Creating a data and map file
   • Edit an existing map file to import.
   For more information, see Editing an existing data and map file.
2. Run the import with the InForm Date and Map files option.
   For more information, see Running the import with the InForm Data and Map files option.

• Creating a data and map file
  The data and map file that are used in the direct import method must be a text file. You can use any text editor that creates plain text files, or develop a conversion utility that automatically formats your raw data.
• Editing an existing data and map file
  

Editing an existing data and map file

To edit an existing import map file:

Note:

If you change definitions in a map file and click Cancel (instead of Finish), an empty map file is saved with the path and filename you specified in the Map field.

1. Click Start > All Programs > Oracle Life Sciences > InForm 7.0.1 > InForm Data Import. The InForm Data Import main window appears.
2. Select InForm Data and Map files.
3. In the Trial Name field, enter the name of the study into which to import the file. The last 10 studies you accessed appear in the drop-down list.
4. Click Next.
   A dialog box appears where you specify the data and map files to import.
5. In the Data field, type the full path name of the data file you want to import, or click Browse.
6. In the Map field, type the full path name of the map file you want to import, or click Browse.

   Note:

   After you enter a file name and open the map file editor, the file is created, regardless of whether you click Start or Stop. This file is stored in the same location as the pfimport.exe file.
7. Click Edit Map File.
   The Field Definition dialog box appears.
8. To edit the map file:
   1. Specify whether the data is targeted for CRF items or CRF itemsets. For more information, see Specifying a submission type.
   2. Specify the input field type. For more information, see Specifying an input field type.
   3. Specify the definition of each map file, one field at a time. For more information, see Building an item path.
   4. Specify the data type. For more information, see Specifying a data type.
   5. Specify mappings between the values in your import file and the values defined for the target data fields in the InForm database. For more information, see Mapping strings and child controls.
   6. Indicate whether the data contains multiple selection items. For more information, see Indicating data contains multiple selection items.
   7. Check for duplicate information within itemsets. For more information, see Checking for duplicate information within itemsets.
   8. Import information to an unscheduled visit. For more information, see Importing information into an unscheduled visit.
   9. Insert or delete an import field into the import file. For more information, see Inserting or deleting an import field.
   10. Check the map against the import file. For more information, see Checking the map against the import file.
9. After you have saved the map file, exit the map file editor to return to the InForm Data Import utility window to import the data and map file. For more information, see Running the import using the data and map import file.

• Specifying a submission type
  
• Specifying an input field type
  Use the Field Definition dialog box to define each map field one at a time. Each map field corresponds to a data item in the import file.
• Building an item path
  If you selected InForm Item Path as the item type, you must specify the RefName path for the target CRF data item for the field in the import file.
• Specifying a data type
  You must specify a data type for each import field definition that you create as an InForm item path field.
• Mapping strings and child controls
  Use the InForm Data Import utility to map field values in your import file to the database definitions of CRF controls, which have predefined values.
• Indicating that data contains multiple selection items
  To import data to a multiple-selection control, a checkbox group, or a multiple-selection drop-down list:
• Checking for duplicate information within itemsets
  The InForm Data Import utility can determine whether data already exists in the database by comparing the data itemset in which you are mapping to existing itemsets in the database.
• Importing information into an unscheduled visit
  
• Inserting or deleting an import field
  
• Checking the map against the import file
  Use the InForm Data Import utility map file editor to review the map field definitions against the actual import data that you will be processing.
• Navigating the map file
  As you create the fields in a map file, the field definitions are strung together in a sequence in which you can move back and forth.

Specifying a submission type

1. Select one of the following options:
   • Form—If all of the data in the import file is targeted for regular CRF items.
   • Itemset—If all of the data in the import file is targeted for CRF itemsets. Optionally, to specify that you want to import only data that updates existing itemsets, select Disallow New Itemset Rows.
2. If you want to import data that only updates existing unscheduled visits, select Disallow New Repeating Visit Instances.
3. In the Reason String field, type the text that should appear in the Reason for Change section on the Data Value(s) screen if data is updated in the data load. The default reason is Lab Import.
4. Click Continue.
   The Field Definition dialog box appears.
5. To define map fields, follow the procedure in Specifying an input field type.

Specifying an input field type

Use the Field Definition dialog box to define each map field one at a time. Each map field corresponds to a data item in the import file.

In the Field Definition dialog box, select one of the following field types:

• InForm Item Path—Contains data that is targeted to a data item on a CRF. When you select this option, you must provide additional information about the import field. For more information, see Building an item path.
• Patient Field – Number (Initials)—Contains subject identification information in either patient_number (patient_initials) format or in the form of a subject database ID. If your import data identifies each subject by the subject database ID, select the Field Contains Known Patient ID checkbox.

  When you select this option, the definition of the map field is complete, and you can move to another map field definition or save the map file and exit the map file editor. For more information, see Navigating the map file.

• Site Mnemonic Field—Contains the mnemonic of the site where the subject is enrolled. When you select this option, the definition of the map field is complete, and you can move to another map field definition or save the map file and exit the map file editor. For more information, see Navigating the map file.
• Itemset Index Field—Contains the itemset index, a 1 based row number. Used to identify an existing row of an Add Entry or Repeating Data itemset. When you select this option, the definition of the map field is complete, and you can move to another map field definition or save the map file and exit the map file editor. For more information, see Navigating the map file.
• Ignore This Field—Indicates that you do not want the field to be imported. When you select this option, the definition of the map field is complete, and you can move to another map field definition or save the map file and exit the map file editor. For more information, see Navigating the map file.
• Unit Symbol for previous field—Contains the symbol for the units that apply to the previous field in the import and map files. The symbol of a unit is the text that identifies the unit on the CRF, as defined in the SYMBOL attribute of the UNIT definition in the appropriate XML file. When you select this option, the definition of the map field is complete, and you can move to another map field definition or save the map file and exit the map file editor. For more information, see Navigating the map file.
• Comment Field for previous field—Contains the comment text that is associated with a form or itemset. When you select this option, the definition of the map field is complete, and you can move to another map field definition or save the map file and exit the map file editor. For more information, see Navigating the map file.

Optionally, select one or more of the following checkboxes:

• Comma separates multiple-values—Indicates that the import file contains data which will populate multiple-selection controls such as radio button groups, checkbox groups, and drop-down lists.
• Match Itemset instance with this field—Indicates that you want the InForm Data Import utility to check for duplicate data in the import file before importing to the InForm application.
• Match Repeating visit instance with this field—Indicates that you want the InForm Data Import utility to check for duplicate dates of visit for the current field in the import file and a date of visit for a repeating visit already in the InForm database.

Building an item path

If you selected InForm Item Path as the item type, you must specify the RefName path for the target CRF data item for the field in the import file.

To build an item path, do one of the following:

• Type the path in the InForm Item Path text box.

  For more information, see Entering an item path explicitly.

• Select each RefName from the drop-down lists in the Build Path From Database dialog box.

  For more information, see Using the Build Path from Database dialog box.

• Entering an item path explicitly
  To specify an item path, use the following item path:
• Using the Build Path From Database dialog box
  

Entering an item path explicitly

To specify an item path, use the following item path:

0.Visit.Form.Section.Itemset.Item[.control[.control…]]

Each component of the item path is the RefName used to define an element:

• 0—Indicates the current subject.
• Visit—RefName of the visit, as specified in the XML file that contains the visit definition.
• Form—RefName of the CRF or other form, as specified in the XML file that contains the form definition.
• Section—RefName of the section, as specified in the XML file that contains the section definition.
• Itemset—RefName of the itemset, as specified in the XML file that contains the itemset definition. If the import data for which you are creating a map field definition is a regular CRF item, not an itemset, type 0.
• Item—RefName of the item, as specified in the XML file that contains the item definition. Create a separate map field for each item in an itemset.
• Control—RefName of the control, as specified in the XML file that contains the control definition. To access an element of a group control, refer to each parent control in which the child element is nested. For example, to address one of two text controls within a group control, type the RefName of the group control followed by the RefName of the text control, and separate the names with periods, as follows: GroupControlRefName.TextControlRefName.

Examples

• The item path for the TEMPTEXT field in the TEMPTEXT item in the VS section of the VSL form in a visit called VISIT1 appears as follows:

  0.Visit1.VSL.VS.0.TEMPTEXT.TEMPTEXT

• The item path for an item in an itemset appears as follows:

  0.Visit1.SS.SECTION2.SS2GROUP.ONSETDATE.ONSETDATE

  The control is a date control called ONSETDATE, in the ONSETDATE item of the SS2GROUP itemset in the SECTION2 section of the SS form in VISIT1.

• The item path for a text control nested within the VIEW radio control item in the CHESTXRAY section of the ECG form in VISIT1 appears as follows:

  0.Visit1.ECG.CHESTXRAY.0.VIEW.VIEWRADIO.OTHERTEXT

The item is identified by the VIEW RefName; the radio control is identified by VIEWRADIO, and the text control is identified by OTHERTEXT.

Using the Build Path From Database dialog box

1. In the Field Definition dialog box, select InForm Build Path.
2. Click Build Path.
   The Build Path From Database dialog appears.
3. From the Visit drop-down list, select the RefName of the target visit.
4. From the Form drop-down list, select the RefName of the target CRF.
5. From the Section drop-down list, select the RefName of the target section.
6. Optionally, from the Itemset drop-down list, select the itemset RefName to load the import data into an itemset.
7. From the Item drop-down list, select the RefName of the target item.

   Note:

   You must create a separate map field definition for each item in an itemset.
8. From the Control and Child Control drop-down lists, select the RefName of the target group and child controls.
9. Click OK.

Specifying a data type

You must specify a data type for each import field definition that you create as an InForm item path field.

To specify the data type of an import field:

• Click the appropriate button in the Data Type section.

  The InForm Data Import utility issues an error if any of the following exist:

  • An invalid integer field. An invalid integer field cannot be fully converted to an integer value. For example, 123$ is an invalid integer field.
  • A string identified as a floating number that does not meet the specification for the CRF control for allowed number of digits before and after the decimal point.
  • A string identified as a text control that is not within the defined size range for the CRF text control.

Mapping strings and child controls

Use the InForm Data Import utility to map field values in your import file to the database definitions of CRF controls, which have predefined values.

Additionally, the mapping feature generates mappings in compound controls between individual child controls and their database ID paths.

• Mapping strings
  When the target of an input data field is a control for which an online user selects a predefined value, the value of the import field must be the same as the value of the selected control as defined in the database. These values are case-sensitive.
• Mapping child controls
  When the target control is nested within another control (for example, a field within a list of radio buttons), you must create separate map fields for the group control and for each child control within the group.

Mapping strings

When the target of an input data field is a control for which an online user selects a predefined value, the value of the import field must be the same as the value of the selected control as defined in the database. These values are case-sensitive.

If your import file does not match the defined database values, you can convert your file to match them.

Alternatively, you can use the string mapping feature of the InForm Data Import utility to specify mappings between the values in your import file and the values defined for the target data fields in the InForm database.

To use this feature while creating the definition of a map file field:

1. In the Field Definition dialog box, click Map Strings.
   The String Map dialog box appears.
2. In the top field, type a possible value of the control as it appears in the import file.
3. In the next field, type the value of the control as it is defined in the database. This definition is specified, generally with a VALUE attribute, in the XML file that is used to load form and data item definitions into the database.
4. Click Map To.
   The InForm Data Import utility transfers the pair of values to the Currently Mapped Strings field. For example, if you typed Yes as a value that appears in your file and Y as the defined control value, the Currently Mapped Strings field shows the mapping as Yes maps to Y.
5. Repeat the mapping definition for each possible combination of values that the field can have in your import file and in the database definition of the control.
6. Click Update Map.

Mapping child controls

When the target control is nested within another control (for example, a field within a list of radio buttons), you must create separate map fields for the group control and for each child control within the group.

Similarly, your import file must contain fields for the group control and for each possible child control selection.

To assign a specific value to the group control selection, the InForm Data Import utility maps child control names to their database ID paths.

To generate child control mappings for a group control map field:

1. In the Field Definition dialog box, click Map Strings.
   The String Map dialog box appears.
2. Click Generate Child Control Mappings.
   The Currently Mapped Strings field shows the mappings between child control RefNames and their database IDs. In the import file field that corresponds to the map field that defines the group control, type the child control RefName for which you are providing data.
3. Click Update Map.

Indicating that data contains multiple selection items

To import data to a multiple-selection control, a checkbox group, or a multiple-selection drop-down list:

1. In the import file, include all applicable selections in a single field. Separate each selection with a pipe (|).
   For example, if you want the cigarettes and cigars checkboxes to be selected in a list containing cigarettes, cigars, and Not Done, and the values defined for those selections are “cigarettes,” “cigars,” and “ND,” the import file should contain a field with the following value:

   |cigarettes,cigars|

2. Define a map field as an InForm Item Path field that references the parent control for the checkboxes or the drop-down list.
3. In the Field Definition dialog box, select Comma separates multiple-values.

Checking for duplicate information within itemsets

The InForm Data Import utility can determine whether data already exists in the database by comparing the data itemset in which you are mapping to existing itemsets in the database.

For example, if you are importing lab information and the subject name, the data, and the type of test match data are already in the database, this might indicate that the data is a duplicate. The InForm Data Import utility recognizes this as duplicate data and does not add a second instance of the data in the database.

To use this feature:

1. In the Submission Type window, select Itemset.
2. Click Continue.
   The Field Definition dialog box appears.
3. Click Next to navigate to the data object.
4. Select InForm Item Path for the data object to match to an itemset in the database.
5. Select Match Itemset instance with this field.
6. Repeat these steps for any other data items you want to compare.

Importing information into an unscheduled visit

1. In the Submission Type window, select Itemset.
2. Click Continue.
   The Field Definition window appears.
3. Select the Item Path for the date of visit to match to a repeating visit in the database.
4. Select Match Repeating visit instance with this field.
5. Repeat these steps for any other unscheduled visits to import.

Inserting or deleting an import field

1. In the Field Definition dialog box, click Insert Field.
   The InForm Data Import utility clears the data entry fields on the Field Definition dialog.
2. Type the definition for the new field.
3. Click Next, Back, or Finish, as appropriate.
   The InForm Data Import utility inserts the new field definition immediately before the field that was displayed when you clicked Insert Field.
4. To save the map definition, click Finish.

   Note:

   You cannot navigate away from the field until you create or delete the new field definition by clicking Finish or Delete Field.
   To delete an import field definition:
5. Click Next or Back to find the field definition to delete.
6. Click Delete Field.
7. To save the map definition, click Finish.

   Note:

   If you change definitions in a map file and click Cancel (instead of Finish), an empty map file is saved with the path and filename you specified in the Map field.

Checking the map against the import file

Use the InForm Data Import utility map file editor to review the map field definitions against the actual import data that you will be processing.

To check the map file against the first line of the import file:

• In the Field Definition dialog, navigate through the field definitions and compare the data that appears in the Sample Data field with the data for the import file.

Navigating the map file

As you create the fields in a map file, the field definitions are strung together in a sequence in which you can move back and forth.

Use the control buttons at the bottom of the Field Definition dialog box to do the following:

• To view a field that occurs earlier in the map file, click Back.
• To view a field that occurs later in the map file, click Next.
• To create a new field definition, advance to the last field in the map file and click Create Next.

  Note:

  You cannot navigate away from the field until you create or delete the new field definition by clicking Finish or Delete.