Regulatory Packets

When all required documents are collected, the Start-Up Specialists, the sponsor, or the CRO forwards an initial regulatory documents packet for collecting the documents from various contacts on the site. Main contacts receive emails with a list of regulatory documents required. If no main contacts are specified for a site, then the Principal Investigator of the site will receive the email. The administrator can set up the email template that would be sent out with regulatory packets. The email can also include document templates as attachments for specific document types if the clinical research enterprise wants to adhere to specific formats for the documents. The Main contacts, on receiving the email, go about the task of collecting the documents, getting them approved by the Principal Investigator, and submitting them to the site. They can submit documents to the site by logging into the site and adding them or by emailing them to the room. If the documents are emailed into the room, it is the SSU Specialists’ responsibility to add them to the sites.

You can choose to send regulatory packets for one or multiple sites. Before sending regulatory packets, the administrator can set up email templates and document templates for specific document types as required.