Adding each site and contact individually

Sites can be created afresh, or added from a list of previously created sites in other rooms related to the same sponsor in a domain. This is especially helpful if the sites are located in multiple locations.

So users might want to create sites with the same name but different metadata like contacts, addresses, IRB/EC, and other details. It can also happen that a site is conducting different types of clinical trials, hence you might want to keep the same name but the rest of the data can differ. Metadata such as the country, and IRB/EC will be added to the new site only if the room has them configured and available.

To create sites, follow the steps below:

  1. Click on the Sites modal from the left-hand navigation pane and click on the +Add button from the top menu bar and select +Add option.

  2. On the Create Site form, add the following details as a part of Step 1: Site Information and click on the Next button.
      • General Information
        • Institution Name*
        • Principal Investigator*
        • CRA
        • Start-Up Specialist
        • Main IRB/EC
        • IRB/EC Submit Date
        • IRB/EC Approval Date
      • Site Contact Information
        • Address
        • Phone Numbers
      • Additional Information
        • Site Number
        • Site
        • Disable Auto Site Name
        • Reason for not using the auto site name
        • Expiration Date
        • Status
        • Preferred Communication Mode
        • Reg Pack Sent Date
        • Expected Submission Date
        • Site Activation Date
        • eFeasibility Status
        • Effective Closure Date
        • Do not inherit security from the template folders
        • Other
        • Country Approval Date
        • Status Date
        • Organization Name
        • Alternative Site Address(es)
        • Pharmacy Address(es)
        • Laboratory Address(es)

  3. Add the following details as a part of Step 2: Contacts and click on the Next button.
      • Add an existing contact by selecting the +Add Existing button
      • Create a new contact by selecting the +Create button
      • Select a contact and click on the Edit button to make changes to the existing contact.
      • Select a contact and click on the Delete button to remove the contact.

  4. Add the following details as a part of Step 3: IRB/EC
      • Add an existing IRB/EC by selecting the +Add Existing button
      • Create a new IRB/EC by selecting the +Create button
      • Select an IRB/EC and click on the Set as Central button
      • Select an IRB/EC and click on the Set as Local button
      • Select an IRB/EC and click on the Edit button to make changes to the existing IRB/EC.
      • Select an IRB/EC and click on the Remove button to remove an existing IRB/EC.

  5. Add the following details as a part of Step 4: Required Documents and click on the Next button.
      • Click on the +Add button to add the required documents
      • Select a required document and click on the Remove button.

  6. Add the following details as a part of Step 5: Amendments and click on the Next button.
      • Select an existing amendment and click on +Set Applicable.
      • Select an existing amendment and click on -Set Not Applicable.
      • Enable the ‘Show only Applicable’ toggle button to display only the applicable amendments.

  7. Verify all the information in Step 6: Review and Confirm and click on the Create button.