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Protocol Tracking Management System (PTMS)

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



Caption: Protocol review workflow and current status.


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.

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This page last reviewed: November 09, 2011