Study Start-Up Contacts

This section describes in detail the various user roles available in SSU module:

  • Clinical Research Associate (CRA)
  • Start-Up Specialist
  • Regulatory Approver
  • Site Activation Member

  • Other Site Contacts

  • Site Activation Member

After site information is entered in TI, the regulatory packet is subsequently sent out to the site members. If you are added to the Site Activation Member group, you are able to submit Essential/Required Documents to the SSU module for the Start-Up Specialist and Regulatory Reviewer

to review. As a Site Activation Member, you can see and track the progress of Essential/Required Documents collection, and activate the site when required.

Clinical Research Associate (CRA)

A CRA is responsible to conduct a clinical trial, and oversee various important site related functions like initiation, compliance with protocols, site visits, adherence to good clinical practices, integrity of the data collected, and protection and safety of the human subjects of the study. A CRA adds documents to a site as a part of site visits. A CRA needs to be an editor in the room to be added as a CRA in a site.

Start-Up Specialist

The Start-Up Specialist is a part of the Site Activation Member group and is the first reviewer of the SSU documents. Documents can be mailed into the specific SSU email address, imported, or attached individually in Trial Interactive. The Start-Up Specialist will review and approve, or reject the document(s) and push them to the Regulatory Reviewer for final review. The Start-Up Specialist will also activate the site after the Regulatory Reviewer approves all Essential/Required Documents at each site. A Start-Up Specialist can be an Editor, or Admin in the room.

Regulatory Approver

The Regulatory Approver is the second and last reviewer of the SSU documents. (Email notifications can be set up to notify the Regulatory Approver that there are documents pending for review). The Regulatory Approver will review and approve or reject the document(s) in the Regulatory Review section in the SSU module.

Other Site Contacts

Besides the ones mentioned above, there are various other site contacts that can be added to a site. 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.
Note: A SSU specialist cannot be a site contact and a 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.