Summary

This article covers accessing the study regulatory body screen and the default fields available.

Table of Contents

• Access Study Regulatory Body Screen
• Default Fields
  • Name
  • Countries
  • Type
  • Regulatory Body Email
  • Main Contact
  • Documents
  • Countries associated in this Study
  • Sites reporting to this Regulatory Body
  • Regulatory Submissions
  • Site Personnel Documentation

This screen pulls high level information from the existing regulatory body record, and adds to it a few data collection fields that are of relevance at the study and regulatory level.

From the Study Regulatory Body screen we can view any study documents associated with the regulatory authority, as well as which study sites are currently reporting to it. We can also quickly access any personnel documentation for the personnel working at those sites to view things like CV’s or training records. Also on this screen is a listing of the regulatory submissions that have been added to the regulatory body, along with links to access them.

Access Study Regulatory Body Screen

This screen can be accessed from the study navigation tree by first expanding the Regulatory sub menu, then the Regulatory Bodies sub menu, and clicking the associated entry in the tree.

The Study Regulatory Body screen can also be reached by clicking on the associated link in the Regulatory Body column of the Submissions Manager for a submission associated with that regulatory body.

Default Fields

The Study Regulatory Body screen contains the following fields by default:

Name

Name is a text field managed by the system. This field is synchronized with information in the regulatory body form maintained at a global level.

Countries

This is a multiple dropdown select maintained by the system. This field displays all countries the regulatory body operates in.

Type

The Type field is a dropdown select maintained by the system. This field displays the type of regulatory authority represented by the form.

Regulatory Body Email

This is a text field managed by the system. This field displays the stored email address for the regulatory body.

Main Contact

This is a personnel field managed by the system. This field will display one or more personnel selected as the main contact for the regulatory body at the enterprise level.

Documents

This is a document upload field allowing the attachment of one or more documents to the study regulatory body form.

Countries associated in this Study

This is a multiple dropdown select field managed by the system. It displays all countries that the regulatory authority is involved in for this particular study. This field is a subset of those countries listed in the Countries field.

Sites reporting to this Regulatory Body

This field is maintained by the system. It displays links to each study site that have listed this regulatory body as one they are reporting to.

Regulatory Submissions

This field is maintained by the system. It displays a list of links to each regulatory submission or amendment that have been associated with this study regulatory body.

Site Personnel Documentation

Clicking the View button found in this field will present the user with a dialog containing a table listing all personnel documents associated with site personnel working at sites that are reporting to this regulatory body. This view can be used to access documents like CV’s and training records for site personnel quickly.

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