Site Master Files

The purpose of this page is to view the list of Site Documents in their Master File format. Documents are grouped in their Master File format according to their TMF Structure.

 

To set a Master File format, the administrator must:

  1. Define a Document TMF Template in the Administration tab System Tables menu item

  2. Set the Enable Document Trial Master Files configuration variable under the Document TMF configuration group to True

  3. Select or create a Template that will be used for Site Documents under the Document TMF configuration group. If the project will use only one Master File format, then select that format under the Default TMF Template and leave the TMF for Country/Project/Site Documents undefined.

  4. Each Document Type must be mapped to the selected template on the Trial Master Files tab. Those documents that are not mapped will be listed under the Unmapped Documents section of the Site Master Files page.

 

To find an item, you can search on any of the three levels by themselves or in concert. In the image below, the levels are called Zone, Section and Artifact. The administrator can name the levels in the Document Trial Master File Templates system table under the Levels tab. The user also can filter the records based on whether they are active or inactive, or simply select all records or can enter a word or string in the Search filter. To remove all search options, click the Reset Filters button.

 

To add a record, select Active under the Records filter and click the Add New button or to edit or view the document parameters, click , which opens the Document module.

 

Download

To download an individual document, click next to the document that you want to download. Click the Download button to download all documents that have been uploaded or linked, which will place them into a zip file. Documents will be grouped within sub-folders based on the TMF Template Structure that is mapped to this project. If a value has been assigned to the Report Zip Password Configuration Variable under the Reports configuration group, it will be used as the password for the zip file. This button will be hidden if the Enable Document Export to Zip File Configuration Variable, which is under the Documents configuration group, is set to False.  If the user experiences a problem in downloading, the document name may be too long. The user can shorten the document name or the administrator can change the configuration variable, Include TMF Level Name in Zip Export, which is under the Document TMF configuration group, to False.

 

Click the Report button to create this list into a PDF document and click the Excel button to open the list into a spreadsheet. You will need t

 

Click Document Trial Master File for more information on the process.

 

Most columns can be sorted in ascending or descending order by clicking the column heading.

 

Click Common Buttons for a description of the buttons found throughout the system and their uses.

 

 

 

Field

Description

Document

This column lists the name of the document. If a document has information entered into the language or version fields, the Language and/or Version information will be displayed below the document name. If the document has been renewed, then the Renewed: Yes will be displayed below the document name. Documents will be grouped in sub-folders based on the TMF Template Structure. Those appearing under Unmapped Documents are not defined within the TMF template. See To set a Master File format.

Comment

This column displays the comment entered for the Document.

Map

A pencil icon indicates that the document type has been mapped. X indicates that the document type has not been mapped to a template for this project. To map a document type for the project, click the pencil at the far left of the row, which opens the Document module. Click the Trial Master Files tab to assign the levels. To assign the levels globally, the administrator should see To set a Master File format.

DATE/EXPIRATION

  

Date

This column indicates the date that the document was listed in the database. If the value is blank and there is a check in the Show Document Date field of the Document Type dialog, then Pending will appear.  If the value is blank and there is no check in the Show Document Date field of the Document Type dialog, then N/A will appear.

Expiration

This column lists the date that the document expires, if entered. If the value is blank and there is a check in the Show Expiration Date field of the Document Type dialog, then Pending will appear.  If the value is blank and there is no check in the Show Expiration Date field of the Document Type dialog, then N/A will appear.

 

An icon will display to the right of each expiration date to indicate its expiration status:

= A green box with a check displayed to the right of the Expiration Date indicates that the document is current.

= A caution icon displayed to the right of the Expiration Date indicates that the document’s expiration date is within the renewal period.

= An exclamation icon displayed to the right of the Expiration Date indicates that the document’s expiration date has passed.

= A renewed icon displayed to the right of the Expiration Date indicates that the document has been replaced by a new version of the document.

TRACKING

 

Collected

This column displays the status of the document as either N/A, pending, or the actual date. If the value is blank and there is a check in the Show Collection Date field of the Document Type dialog, then Pending will appear. If the value is blank and there is no check in the Show Collection Date field of the Document Type dialog, then N/A will appear. This field will be visible if the Display Collected on Overview and List Configuration Variable under the Documents configuration group is set to True.

Received

This column displays the status of the document as either N/A, pending, or the actual date. If the value is blank and there is a check in the Show Received Date field of the Document Type dialog, then Pending will appear. If the value is blank and there is no check in the Show Received Date field of the Document Type dialog, then N/A will appear. This field will be visible if the Display Received on Overview and List Configuration Variable is set to True. This field will be visible if the Display Received on Overview and List Configuration Variable under the Documents configuration group is set to True.

Filed

This column displays the status of the document as either N/A, pending, or the actual date. If the value is blank and there is a check in the Show Filed Date field of the Document Type dialog, then Pending will appear.  If the value is blank and there is no check in the Show Filed Date field of the Document Type dialog, then N/A will appear. This field will be visible if the Display Filed on Overview and List Configuration Variable under the Documents configuration group is set to True.

UPLOAD/LINK

 

Upload/Link Date

This column indicates the date that the document was uploaded or linked to the system. If the value is blank and there is a check in the Show Upload/Link field of the Document Type dialog, then Pending will appear.  If the value is blank and there is no check in the Show Upload/Link field of the Document Type dialog, then N/A will appear. This field will be visible if the Display Upload/Link on Overview and List Configuration Variable under the Documents configuration group is set to True.