Viewing or Editing Site Profiles

After selecting the required view as shown above, the user can edit a site profile as follows:

  1. Select a site from the grid.
  2. Click Edit in the top menu ribbon to open Site Profile of the site selected. The site profile opens, or Double-click a site from the grid to open its Site Profile window.

  3. The Essential Documents Progress panel on the right side shows the Progress percentage bar to track the site completeness as the essential/required documents collected and reviewed.
  4. Below the Essential Documents Progress Bar, the Regulatory Pack Sent Date, IRB/EC Submission Date, and Site Activation Date are automatically displayed as per their entries in the database.
  5. Based on the IRB/EC Submission Date, Next Meeting Frequency and Date, Approval cycle, and Buffer time, the system will predict the Projected IRB/EC Approval Date and display it on the right panel of the site profile window. If, for some reason the IRB/EC did not approve the documents, the system will automatically project the Next Approval Time. Refer to the screenshot below.

    Besides these, based on the Projected IRB/EC Approval Date and Start-Up Processing time (specified in the Study Start-Up Settings), the system will also display the Projected Site Activation Date on the right panel. Refer to the screenshot below:



    But if there are no IRB/EC Submit Date and Expected Submission Date specified in the site profile, the system will not display them in the right panel. Instead it will project the Next Pre-Submission Deadline Date based on the meeting schedule specified in the IRB/EC profile. To display the Projected IRB/EC Approval Date, the system will use the Next Pre-Submission Deadline Date. The process to project the Projected Site Activation Date remains the same as mentioned above. The projected Next Pre-Submission Deadline Dates can be viewed by clicking the last calendar icon next to the Expected Submission Date field.
  6. Make necessary additions or changes to the data fields in the profile. Refer to Creating Sites and Adding Contacts in case of clarifications.
  7. Click Save at the bottom of the panel.