Protocol Tracking Management System (PTMS)

• Supports protocol submission, approval, and monitoring of protocol review process
• Automates the review-process workflow thus facilitating the review of scientific merit of clinical studies
• Reduces the complexity, improves communication between the investigators and reviewers, and accelerates the review process

PTMS Overview

• Role-based
• Principal Investigators (PI) and Protocol Coordinators (PC) are the primary users
• The PI's role includes the following:
• Enters protocol information, attaches necessary files, and submits the protocol and attachments for review;
• Prints the Clinical Research Protocol Initial Review Application (1195) form;
• Monitors the ongoing status of protocol reviews;
• Designates Authorized Users (AU) to have access only to view or manage the protocol information;
• Initiates an Amendment, Serious Adverse Event, Violation, or Termination of the protocol;
• Views protocol with upcoming Continuing Reviews and enters data for the Clinical Research Protocol Continuing Review Application (1195-1) form; and
• Receives e-mail from the system automatically for protocols that require action.
•  The PC's role includes the following:
• Manages the entire protocol tracking process;
• Monitors the status of individual reviews for protocols;
• Assigns reviews to Statistical and Primary Reviewers;
• Associates reviews to Institutional Review Board (IRB) and Scientific Review meetings;
• Records submissions and approvals of protocols to and from Protocol Services;
• Adds minutes and stipulations for a review based on an IRB or Scientific Review meeting;
• Adds new meetings into the system and schedule protocols for review;
• Views lists of protocols that are newly submitted, that have upcoming Continuing Reviews, or are designated for PC action;
• Receives e-mail from the system automatically for protocols that require action.