Required Documents Settings

With the help of Required Documents Settings, Administrators establish and edit the Required Documents for a study. Different document types may be required for all Investigative Sites involved in a study, or there may be documents that are required of investigative sites that are located in particular countries. These settings are typically made at the outset of a study, but they may be modified during the course of a study under certain circumstances.

Once Document Types are set up for a room from Document Types Management, you can set up the Required Documents.

Note: It is recommended that administrators contact the Trial Interactive Project Management Team if any changes or additions are needed here. Once Document Types are set up for a room from Document Types Management, you can set up the Required Documents.
  1. Navigate to Main Navigation -> Settings Module
  2. Select Required Documents from the menus on the left.

    Refer to the screenshot below showing the various options under Required Documents Settings:

Required Documents can be defined for the following:
  1. All Sites
  2. Country-Specific
  3. IRB/EC

    Each of these is discussed in the separate topics and can be viewed from the left pane of this help.