Start-Up Contacts

This section describes in detail the various user roles available in the 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 sitemembers. Suppose you are added to the Site Activation Member group. In that case, 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 for conducting a clinical trial and overseeing 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 to 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 documents are 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, 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.

Note: 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.

Inviting contacts and Managing Security

The world of clinical trials involves many users whose responsibilities range from handling various complex procedures to users who only review and sign documents on a site. To enable them to carry out their duties, the users need to be given proper access and privileges to a site.

To facilitate the above, Trial Interactive (TI) implements a process that can be seamlessly aligned to a real-world scenario. It caters to various questions in a clinical trial to define the role of a user, like

  1. What is the size of the organization?
  2. Does the organization involve users who handle multiple roles or users who are assigned specific roles in a site?
  3. Does the user need to oversee the complete site activities, or is it enough for the user to only be a contact point on the site?

Depending on the functionalities assigned to site users, by answering the above questions, the administrator can choose the right combination of rights and privileges.

TI implements the following process to assign a combination of rights and privileges to site members to enable them to carry out their responsibilities:
  1. It allows two security privileges to be assigned to users – Editor and Reader.

    A reader is allowed read-only access, whereas an editor can perform various other advanced functionalities like adding documents and sending documents for review to activating sites.

    To note, an Admin is a privileged role and is assigned to users only in specific cases discussed later in this guide.
  2. These security privileges can be assigned at two levels:
  1. At room level

If users are already registered in the room, skip the below-mentioned process.

To assign privileges to a user in a room, the Admin has to provide access to the user by inviting the user to the room. On inviting, the user receives an invitation mail in their registered email ID to join the room. The Admin has to follow the process below:-

  • Login into TI and enter the room.
  • Navigate to Dashboard and click the Users Management module.

  • Click Invite, and choose Regular. Fill out the required information.
  • Assign them appropriate roles as defined within Trial Interactive

Note:For Study Start-Up roles, the user needs to at least be an Editor in the room.

  • Enable Study Start-Up as action. Click Create. Refer to the screenshot below:

New users can also be added from within a site by the admin directly. In this case, the user so created receives an invitation mail to join the room.

2. At Site Level

Within a site, the following types of users can be added as site contacts:

  1. Users belonging to a room to which the site belongs.
  2. Users belonging to a room to which the site does not belong.
  3. Contacts of one site can be added as contacts to another site.

Examples of the first case could be CRAs and Start-Up Specialists. In the second case, a user could have been invited to, say, Room 1, but the user is directly added to a site of Room 2 using their email ID. In the third case, a Pharmacy Contact might not be required to access a room but needs to be in the list of contacts of the site and hence can be directly added as a site contact.

  • It provides a group named Site Activation Member that is pre-defined by the system. This is a privileged group almost equivalent to that of an Admin. Users handling multiple roles in a site can be added to this group. This need arises from the fact that certain users might need access to all the sites, even if they are not contacts on a site. To make things easy, you can directly add the user to this group without having to add them to each site.

Note: If a user is added to the Site Activation Members group but at the same time if for some sites the user is added as Reader, then for those specific sites, the system will restrict the user’s permissions down to Reader (minimal access).

Note:Not all contacts need to be added to this group compulsorily. To add a contact to the Site Activation Member Group, Click the Groups tab in the User Invitation window.