How to Import Define Specs

We provide a pre-formatted Excel template for defining dataset metadata.

Users are free to use the Candid user interface for adding dataset metadata, but you may find it easier to use the template to import most (if not all) the dataset metadata details and controlled terminology.

How to Import the Completed Excel Template

1. Navigate to the Dataset Index page for a given Analysis

2. Expand the Bulk Actions list

3. Click Import from the list of actions

4. Select the Excel file you have been diligently working on and click Open

5. Click the Upload and Review Changes button

Excel Template Tab Definitions

• Datasets: Contains the dataset list to import. If the Import column has the value ‘Yes’ Candid will create a Dataset record as well as look for a worksheet with the same name as the dataset containing the variables and try to add them. If there is no corresponding variable worksheet then only the dataset record will get created.
• CDISC CT: Contains all of the standard CDISC controlled terminology. You will need to delete any you do not want imported otherwise all 183 controlled terms and their children will be added to Candid.
• Custom CT: Here is where you can add any additional controlled terms.
• External CT: For example MedDra and WhoDrug dictionary refs.
• VLM: Value Level Metadata. They get added when a dataset - variable name match on the other tabs in the file.
• Where Clauses: These are the where clause (children) of the VLM tab (1 VLM have 1 or more Where clauses)
• Lookup: Do not edit. Used by the variable tabs to supply the correct CDISC 2 values for define.
• Template: this is for reference, and for copying to create new variable tabs.
• … all other tabs are considered Variable lists for datasets you want to import. Two examples are in this file. ADSL and ADAE ADaM dataset variables.

How to Enter Custom Controlled Terminology into the Template

• The rules for adding data to the Custom CT tab are the same as the CDISC CT tab (the colors have no meaning for the import; are there for readability only).
• It’s best (not required) to not put CDISC controlled terminology on the Custom CT tab. The reason is that it would be very easy to put a duplicate CDISC code on the Custom CT tab (Candid’s validation rules will reject duplicates).
• You are free to edit both the CDISC CT and Custom CT tabs as you like (as long as you follow their rules)

Custom CT Column Definitions

Adding the Controlled Term (this parent row)

• Column A - Code: is required and must be a unique value
• Column B - Codelist Code: leave blank
• Column C - Extensible: is required, enter ‘Yes’ or ‘No’
• Column D - Codelist Name: is required, long name of the controlled term
• Column E - Submission Value: is required, represents the SAS Format Name of the controlled term and must be 7 characters or less
• Column F - Synonyms: (enter same value as column D)
• Column G - Definition: is required, description of the controlled term

Adding the Controlled Term Item (children of the Controlled Term parent)

• Column A - Code: is required and must be a unique value
• Column B - Codelist Code: enter the parent Code from the parent’s value in column A
• Column C - Extensible: leave blank
• Column D - Codelist Name: is required, long name of the controlled term item
• Column E - Submission Value: is required, represents the preferred term
• Column F - Synonyms: optional, represents the longer version of the preferred term or a semi colon separated list of synonyms for the preferred term
• Column G - Definition: is required, description of the controlled term item

How to Enter Value Level Metadata into the Excel Template

• coming soon.