FDA CVM eSubmitter Master File User Guide
- June 3, 2024
- FDA
Table of Contents
FDA CVM eSubmitter Master File
Introduction
The Master File Book provides a means of storing Master File information to be reused across submissions and associated books. Reusing this data makes building a submission more efficient, as well as ensuring data consistency across submissions.
Accessing the Master File Book
The Master File book can be accessed in multiple ways. Direct access to the book is available at anytime from the Tools option in the menu bar.
In addition, the Master File book can be accessed from the Master File Description tab of a submission, and associated sections within CMC and VMF submissions using a Master File interface questions listed within the submission.
Selecting a Master File from within a submission Selecting a Master File from with a Supply Chain item
Regardless of the method used to access the master File book, the View Master File List Dialog will open.
A. The Master File List
The Master File List displays all the master files matching the search
criteria, or all master files available when no search criteria are provided.
The list contains the MF File, MF Type, Ownership Status, Subject, Information
Covered, and the date the information was last updated. The list title
contains a count of the master files currently included within the list. In
addition, internal sponsor comments are displayed for the selected master
file.
The following options are available:
- View: Displays all details related to the selected master file.
- New: Allows for new master files to be added to the list.
- Edit: Allows for details on the selected master file to be updated.
- Delete: Allows for the selected master file to be permanently deleted from the list.
There are two modes for displaying the Master File List. The first is the View mode, which is used to manage the overall contents of the master file list. The View mode is available within the application Tools menu. The second is the Select mode, which is used to select a master file as a reference (e.g., to supply chain information). The Select mode is available from within the data screen where the reference is being initiated. The default behavior of some operations is dependent on the mode used to open the Master File List. For example, in View mode using the Enter key on the keyboard or double- clicking with the mouse on the selected row initiates an Edit, while in Select mode the same operation initiates a Select.
B. Search/Sort Criteria
The Search capability allows for searching across all master files contained
within the Master File List. The fields available for searching include MF
File Type (VMF/DMF), MF File Number, and MF Type (Type II/III/IV/V). The
search locates all master files matching all criteria provided. The MF File
Type and MF Type searches retrieve all master files matching the selections
made, while the MF File Number search is based on locating all master files
that begin with the digits entered.
When no search criteria are provided, all master files are listed. A Clear option is provided to clear the search criteria and reset the master file list.
The Sort capability controls the ordering of master files within the list. The sort orders available include File Type and Number, Master File Type, and Ownership Status. The master file list will be reordered whenever a sort order is selected. The default sort order is File Type and Number. The sort order will reset to the default when the Clear option is selected
Entering Information into the Master File Book
A. Creating a New Entry
From the View Master File List Dialog, select New… to create a new entry. This
will open the Add Master File Dialog.
Populate all the required fields: MF File Type (VMF/DMF), MF File Number, and
MF Type
(Type II/III/IV/V). Provide a file reference (i.e., folder location and file
name) to the Letter of Authorization (LOA) providing Right of Reference.
Enter if the master file is owned by the firm. If so, complete the additional associated questions.
The comments field is for sponsor use only and is not included as part of any submission content. It is provided to aid sponsors in the overall management and identification of master file information by allowing the capture of additional information related to each master file.
When finished, select OK to close the dialog, or select Add Another Master File if you wish to create additional entries.
B. Edit Master File
Allows for details on the selected master file to be updated. Master File
information can be edited by first selecting the desired master file from the
Master File List, and then selecting Edit. Alternatively, you can double-click
a master file item in the list to open the same window.
C. Delete Master File
To delete a master file, select the desired master file from the Master File
List, and select Delete at the bottom of the form. A warning message will
appear to confirm the deletion, which after doing so, will remove the master
file from the list.
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