Data Dictionary

On this page you can create or update a Data Dictionary.

Data Dictionary Entries can be edited in a spreadsheet-like table:

  • right-clicking on a row will display a menu with options to insert rows, remove rows, undo and redo changes

  • one or more rows can be selected and moved to a different position

  • one or more rows can be selected and deleted using the right-click menu

  • rows can be copied and pasted. The rows can be copied from the same Data Dictionary, another Data Dictionary or a spreadsheet. Note: take care that the columns being copied match the editor columns, ie. Coded Data, User Data String and optionally a true or false value for Specify.

  • a maximum of 10000 entries can be created. If you have a Data Dictionary which requires more entries, please contact us.

  • clicking the headers of a data dictionary will sort entries by that column.

Standards Compliance

Depending on whether the Data Dictionary appears inside a Standard Library or in a Draft that uses a Standard Library, the controls available and what is displayed changes.

OIDs

If the Data Dictionary was imported from Medidata Rave release 2023.2.0 or higher, the Medidata Rave OID for the Data Dictionary will be displayed. The OID cannot be changed in TrialGrid or in Medidata Rave.

When a Data Dictionary is created in Medidata Rave the OID will be generated by taking the letters (in upper case), numbers and underscore characters from the Data Dictionary Name. Once a Medidata Rave Data Dictionary has an OID the OID does not change, even if the Data Dictionary Name is changed.

The OID is used by Medidata Rave to uniquely identify Data Dictionaries during study amendments.

When a draft is uploaded to Medidata Rave, the OID column will be ignored and a new OID generated from the Data Dictionary name.

Data Dictionary in a Standard Library

In a Standard Library the Data Dictionary Editor displays additional extra controls:

  1. An "Entries can be removed" checkbox. Checking this box signals that any Entry which is not Required (see point 2 below) can be deleted from the Data Dictionary without explanation. If the "Entries can be removed" checkbox is NOT checked then _NO_ entries can be removed from the Dictionary without explanation and the Entry-level Required setting is ignored.

  2. The Data Dictionary Entry "Required" checkbox. Checking this box signals that even if the "Entries Can Be Removed" checkbox is set this Entry is always required and removing it will require explanation.

  3. The "Entries can be added from" checkbox. Checking this displays a list of all other Data Dictionaries in the Draft. Select a Data Dictionary from which Entries can be added without requiring explanation. This feature is used to have a standard dictionary (e.g. Concomitant Medication Route) which holds the list of entries appropriate for a study and a Controlled Terminology list (e.g. Concomitant Medication Route Master) from which entries can be drawn and have the smaller Data Dictionary (Concomitant Medication Route) still be standards conformant since the additional entries came from this pre-approved master list.

Data Dictionary in a draft that uses a Standard Library

The editor for a Data Dictionary displays the following controls when it is used in a Draft that is linked to a Standard Library:

  1. An indication of whether Entries can be removed from the Entry List. This is drawn from the Standard Library setting for this Data Dictionary.

  2. If the Standard Library Data Dictionary has been set to allow entries from a Master Data Dictionary then a search box allowing addition of entries from that Master List is shown.