Start-Up Contacts

Once site information is entered into the TI system, the regulatory packet is automatically sent to the site members for review and action. If users are added to the Site Activation Member group, they gain the ability to submit Essential/Required Documents to the SSU module for review by the Start-Up Specialist and Regulatory Reviewer.

As a Site Activation Member, the user can:

  • Monitor Document Collection: Track the progress of the Essential/Required Documents collection process to ensure all necessary documents are submitted, reviewed, and approved.
  • Activate the Site: Once the required documents are collected and reviewed, the Site Activation Member can proceed with site activation, allowing the site to begin participant enrollment or other study activities.

The following are the various roles available in the SSU Module.

Role Description
Clinical Research Associate (CRA A Clinical Research Associate (CRA) is responsible for conducting clinical trials and managing key site-related functions, including site initiation, protocol compliance, site visits, adherence to good clinical practices, data integrity, and ensuring the protection and safety of study participants. During site visits, the CRA adds documents to the site. To be designated as a CRA at a site, they must have editor access in the room.
Start-Up Specialist As part of the Site Activation Member group, the Start-Up Specialist serves as the initial reviewer of SSU documents. Documents can be sent to a specific SSU email, imported, or individually attached in Trial Interactive. The Start-Up Specialist reviews each document, approving or rejecting it, and forwards it to the Regulatory Reviewer for final review. After the Regulatory Reviewer approves all Essential/Required Documents at each site, the Start-Up Specialist will activate the site. A Start-Up Specialist can hold either Editor or Admin access in the room.
Regulatory Approver The Regulatory Approver is the final reviewer of SSU documents. (Email notifications can be configured to alert the Regulatory Approver when documents are pending review.) The Regulatory Approver reviews each document in the Regulatory Review section of the SSU module, approving or rejecting it as necessary.
Other Site Contacts

Besides the ones mentioned above, various other site contacts can be added to a sit. Some of them are mentioned below:

  1. Principal Investigator
  2. Sub-Investigator
  3. Pharmacy Contact
  4. Laboratory Contact
  5. Contracts Contact
  6. Finance/Budget Contacts
  7. Co-Investigator
  8. Research Specialist

Note:

  • A Principal Investigator is the most important contact for a site, as sites cannot be created without a Principal Investigator.
  • An SSU specialist cannot be a site contact and an SSU Specialist at the same time. Except for the CRA, all the contacts discussed in this section can be viewed from the Contacts module. You can view sites in the BY CRA view from the Sites module.