Required Documents

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 for 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 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.

  1. Navigate to Navigation Grid -> Settings Module
  2. Select Required Documents from the menus on the left.

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

Required Documents can be defined for the following:

  • All Sites
  • Country-Specific
  • IRB/EC