Defining Dictionary-wide Informative Notes

When you define an Informative Note for an entire dictionary, each term in the dictionary inherits the Informative Note as well. This inheritance is useful if, for example, you want to associate each term in a dictionary with a URL that contains its name. By defining a single, dictionary-wide Informative Note that includes a variable for the term name, you can create context-sensitive Informative Notes for each term in the dictionary and maintain these notes with a single definition.

Note:

Relation records do not inherit Informative Notes from their dictionaries.

You can define dictionary-wide Informative Notes only for strong dictionaries of Active status.

1. Open the Define Dictionaries window and select a dictionary.

2. Click the Informative Notes button. The Maintain Dictionary Informative Notes window opens.

3. In the Informative Note field, click the ellipsis (…). The list of values opens.

4. Choose an attribute from the list of values and click OK. TMS populates the Informative Note and Type fields with your attribute selection.

   In addition to user-defined Attributes, the list of values includes RDC Action Text. Select this Attribute to create a label for the Special Listings tab in Oracle Clinical Remote Data Capture Onsite Release 4.5.3.10 and above. See RDC Action Informative Notes.

5. Enter a Value:

   • For most Standard type notes, enter the text, date, or numeric value to display in the note.

   • For Standard type notes with a data type Memo, TMS displays the word Memo in blue type. To enter the text:

     1. Double-click the word Memo or select the drill-down option. TMS opens the Memo (Attribute Name) window.

     2. Enter or paste the text you want to store in this field.

     3. Click OK. The text is stored as a CLOB (character large object).

   • For URL type notes, enter the URL beginning with a protocol (http:// or ftp://). To use variables, see Entering Variables in Dictionary-wide URL Informative Notes.

6. Save.

Note:

For information on Informative Notes of type Algorithm, see Defining Informative Notes for SMQ Algorithms.

For more information, see:

• Entering Variables in Dictionary-wide URL Informative Notes
  
• RDC Action Informative Notes
  
• Defining a Dictionary Version Informative Note
  

Entering Variables in Dictionary-wide URL Informative Notes

You can use variables to add information in the text of the URL. For example, if you include the variable %TERM% in a dictionary-wide URL Informative Note, TMS substitutes the term name in the text of the URL. Thus, when you define the dictionary-wide URL Informative Note https://www.google.com/#q=%TERM%, the term rubeola inherits https://www.google.com/#q=rubeola as an Informative Note. You can connect to this URL from the Browse Informative Notes window.

You can insert the following variables into URL values. They correspond to columns in two internal TMS tables.

• These variables correspond to columns in the TMS_DICT_CONTENTS table and apply to term records:

  • TERM

  • TERM_UPPER

  • VALUE_1, VALUE_2, VALUE_3, VALUE_4

  • COMMENT_TEXT

  • CATEGORY

  • DICT_CONTENT_ID

  • DICT_CONTENT_CODE

  • DICT_CONTENT_ALT_CODE

• These variables correspond to columns in the TMS_DEF_DETAILS table and apply to Informative Notes:

  • LABEL_TEXT

  • LABEL_TEXT_UPPER

  • DEF_DETAIL_ID

  • DICT_INFO_HDR_ID

To add a variable to a URL Informative Note:

1. Click in the Value field and enter the basic URL.
2. While the cursor is in the Value field, press F9 or select Edit to see the list of values.
3. Select a variable and click OK. TMS appends %variable% to any text in the Value field.

You can also cut and paste variables in the Value field to create a valid URL.

RDC Action Informative Notes

If you have TMS integrated with Oracle Clinical and are using Remote Data Capture (RDC) Release 4.5.3.10 or above, you can use the RDC Special Listings page to display information about a patient's adverse events, concomitant medications, or other data in TMS.

You use a special type of Informative Note to specify the text of the item in the drop-down list on the Home and Casebooks pages for a particular dictionary. By default, this text is: Review TMS_Dictionary_name / DCM_name. On the Special Listings page itself the same value (without "Review") appears in the Listing Type drop-down.

You can replace the dictionary name with text that would be more meaningful to RDC users, such as Adverse Events or Concomitant Medications, so that the item in the Home and Casebooks pages' drop-down list would be "Review Adverse Events / DCM_Name," for example, rather than "Review MedDRA / DCM_Name."

To do this:

1. In the Informative Notes field, select RDC Action Text from the list of values.
2. In the Value field, enter the text you want to appear in the RDC drop-down list, such as Adverse Events or Concomitant Medications.
3. Save.

   Note:

   You can define only one Informative Note of Attribute RDC Action Text for each dictionary. The value text is used in RDC for every study and domain where the dictionary is used.

Defining a Dictionary Version Informative Note

You can use a specialized, predefined Informative Note Attribute called Dictionary Version to assign a version number to a dictionary. To define the version for a dictionary, using an Informative Note:

1. Open the Define Dictionaries window and select a dictionary. You can define a version number for base or virtual dictionaries.
2. Click the Informative Notes button. The Maintain Dictionary Informative Notes window opens.
3. In the Informative Note field, click the ellipsis (…) button. TMS opens the Informative Note Attributes list of values window.
4. Choose Dictionary Version from the list of values, and click OK. TMS populates the Informative Note and Type fields with your attribute selection.
5. Enter the version number in the Value field.
6. (Optional) Enter a status to define this version number further.
7. Save. TMS validates the entry and saves the Informative Note, returning you to the Define Dictionaries window.