Adding TFLs

TFLs can be added to an analysis in bulk by building them from templates, by importing an Excel file, or one at a time.

Add TFLs from Template

1. Navigate to an existing analysis.

2. Click the TFLs link in the upper right corner of the Analysis Details page.

3. Expand the Bulk Actions drop down menu.

4. Click Add from Template. The Add New TFLs from Template wizard will open.

5. Select Template Group and click Next.

6. Select a template TLF item from the list by clicking the Select button for the item you wish to base new TLFs from. Click Next.

7. Fill in the values for each replacable token defined in the template.

8. Click Add to create another TFL with different token values. Create as many as you need and click Next.

9. The Confirm page shows you a summary of the TFL metadata that will be created. You can always go back in the wizard and make changes if you need to.

10. Click Yes, I’m Sure. The wizard will add the new TFLs (and their titles, footnotes and any instructions you provided) to your analysis. The new TFLs will be set at the state of New and an audit trail record will be added indicating the date time and name of the user that added them.

Add TFLs via Excel

1. Navigate to an existing analysis.
2. Click the TFLs link in the upper right corner of the Analysis Details page and the TFL Index page will open.
3. Click the Export button and a TFL spreadsheet with any existing TFLs in the system will be created.
4. Add new rows to the spreadsheet (see the Information for a summary of the rules).
5. Save the spreadsheet file.
6. Import spreadsheet:
7. From the TFL Index page click the Bulk Actions button.
8. Click Import and an import preview page will be shown.
9. Click Confirm to submit changes.
10. Delete the spreadsheet file.

Add TFL by cloning an existing one

1. Navigate to an existing analysis.
2. Click the TFLs link in the upper right corner of the Analysis Details page, the TFL Index page will open.
3. Click the Details button for the TFL you want to clone, the TFL Details page will open.
4. Click the Clone button and the Clone TFL form will open.
5. Enter the new name and optionally a TFL number.
6. Click Submit.

Add TFLs one at a time

1. Navigate to an existing analysis.
2. Click the TFLs link in the upper right corner of the Analysis Details page.
3. Click the Add button.
4. Select the Type, Class, and Name, (Number is optional).
5. Click Submit.

Required Fields

Type

Type is the primary descriptor of what kind of TFL it is. The available types are defined by the Administrator. For example: Table, Figure, or Listing.

Class

Class is a more flexible grouping that can describe a common trait or purpose of the TLFs. The available classes are defined by the Administrator. For example: Efficacy, Safety.

Name

Name of the TFL.

Number (Optional)

For example: 14.0.0.1 (Number is optional and can be updated later).