Summary

This article explains the various actions that can be used to add and configure requirement sets both in regulatory managers and to regulatory submissions found within studies.

Table of Contents

This section explains the various actions that can be used to add and configure requirement sets both in Regulatory Managers and to Regulatory Submissions found within studies. This article also explains possible pitfalls and common best practices for utilizing these features.

Standard Requirement Sets vs. Study Requirement Sets

Standard Requirement Sets are those created from the Regulatory Managers. They are assigned to Regulatory Bodies and Regulatory Categories so they can be easily imported into a new study. These are essentially a repository of templates. Because they are not yet associated with a study, data entry into these standard requirement sets is not allowed.

Adding Standard Requirement Sets

Study requirement sets are any requirement sets that have been created or imported into an active study by adding them to a Regulatory Submission. Standard requirement sets can be imported into a study as study requirement sets. Once they have been brought into a study, data can be entered into these sets as with any other set in a regulatory submission. The same features are available for modifying and creating requirement sets within a study as there are within the Regulatory Manager, with a few additional options. The primary difference is data is collected in study requirement sets, whereas standard requirement sets are templates for study requirement sets.

New Requirement Sets vs. Shared Requirement Sets

There are two types of requirement sets that you will find throughout the system. The first is a typical new requirement set. A requirement set by default is only associated with one regulatory body/category in the Regulatory Managers or one submission within a study. Because this set is not associated with any others, when they are displayed in a submission or regulatory category, the individual rows of the set will have delete icons and can be permanently removed from the set. Entering data into these sets from within a study will only affect the system in that one place.

Shared requirement sets, however, are common to one or more regulatory bodies in the Regulatory Manager, or one or more submissions within a study. This means that the system identifies these sets in multiple locations as being the same set. In the context of the Regulatory Managers, this shared relationship can be defined beforehand so that when shared standard requirement sets are imported into a new study, they will already have that relationship. In the context of a study and its contained submissions, this means that when data is entered into a set, or parts of a set are marked complete, this will be automatically populated by the system everywhere the set is shared within the study.

Sharing Requirement Sets

Requirement sets can be shared by clicking the Share Existing Set Action in the Actions Menu on either the Regulatory Category Screen or the Regulatory Submissions screen. Doing so will provide you with a dialog to select from existing requirement sets to locate one or more to share.
By choosing from existing regulatory bodies and categories a requirement set can be shared in the Regulatory Managers.


By choosing from existing regulatory bodies and submissions a requirement set can be shared between submissions in a study.

Adding and Configuring Requirements in a Set

Requirement sets can be added to the system and configured in one of several ways.

Downloading a Structure Template

The Download Structure Template action provides you with a blank Excel template that is used to configure requirement sets in the system. Structure templates are explained in more detail here: Understanding the Structure Template.


The Export This Configuration action can be clicked on any existing requirement set in order to obtain a download of a structure template that would produce the requirement set currently displayed on the screen.


Loading Requirements

This can be done by clicking the Load Requirement Set button displayed on the screen when a requirement set currently has no requirements loaded.


Or it can be done by clicking the Load New Set action in the Actions Menu that is available once requirements have already been loaded to the set. This will trigger a confirmation window informing you that loading a new set will overwrite the old one.


Note: Overwriting a requirement set in a study will destroy the older version, eliminating any data you might have stored within it. If you are simply trying to modify the structure of the existing requirement set without losing the data, it is recommended you first perform a Values Export.


In both cases you will be prompted to provide some configuration of a Structure Template. The system will then use this template to generate the data collection interface you desire.

Deleting Requirements

Once requirements have been added to a requirement set, each requirement, or row of the displayed table, will be shown alongside a delete icon. This is only the case if the requirement set is unshared. By clicking the delete icon you can remove individual rows of a requirement set without having to reimport a new structure template.

Note: If sets are shared across multiple categories within a single regulatory body, deleting a set shared in one category will remove it from other categories in the same regulatory body without warning.



Hiding Requirements

If a requirement set is shared between multiple regulatory bodies or submissions, rather than a delete icon, a hide icon will be displayed.


This is because the overall structure of the requirement set is used by more than one record in the system. So rather than allow you to permanently delete that row, which may contain information relevant to another submission, we allow you to simply hide it so that the completion of that row does not affect the overall completion of that particular submission.

Once some rows of a requirement set have been hidden, and the form has been saved, when you return to the requirement set it will have a Reveal Hidden button. Clicking this will restore the components of the total set that you had previously hidden.


Entering Data and Completing Sets

See Managing Requirement Sets for details on entering and updating data, adding and moving rows, deleting rows, and setting completion status.

Importing and Exporting Values from a Requirement Set

Using the actions provided in the Actions Menu, the data entered into requirement sets within a submission can be imported or exported. This can be used to enable offline data entry, as well as provide a means to store data when modifying the structure of your requirement set.

Importing Values

By using the Import Values action you can load values into the requirement set using an Excel spreadsheet. The format of this spreadsheet must match that of the requirement set to be accepted. The easiest and most common way to obtain a format that will work is by using the Export Values action.

Note: The fixed fields of the requirement set must be in the same location and have the same value in the Excel document being imported in order for the import to succeed.



Exporting Values

By clicking the Export Values action you will be provided with an Excel download whose structure matches that of the requirement set. All fixed fields in the requirement set will be locked upon opening the Excel document to discourage tampering with them. Modifying these fields will result in a change of format that will not be accepted by the Import Values action. The data entry-capable fields will be unlocked in the export and will contain the values, if any that you have entered into the system.

Need more help?

Please visit the Fountayn Contact Information page.