Welcome to the Quality Collaborative

What is required?

Introductory Training Content

Acceptance Content List

Checklist for Submission

Optional Content:

Quality of Life Form (1)

Quality of Life Form (2)

Protocol:

Protocol

Does this initiative qualify as research?

  • TARGIT Collaborative Group Quality Collaborative is NOT a research project.
  • TARGIT Collaborative may be defined as a Quality Collaborative that functions as a data registry/quality improvement initiative.

What are possible plans for Publication?

While the main purpose of data collection by the TCG Breast QC is for quality improvement, we acknowledge that the information contained within the QC will contain valuable elements that may serve as a benefit if and when utilized in additional manners. It is expected that any publication derived from the Quality Collaborative will require separate IRB approval.

Three possibilities of secondary usage of data are recognized as appropriate by the QC:

  1. Individual User or Group Publications
  2. Collaborative-wide Publications
  3. Registry-based Clinical Trials

What is the nature of the data collected for the QC?

  • Data permissible for collection includes BOTH prospective and retrospective data.
  • It is the responsibility of the interested site to ensure proper local consent for data usage is obtained prior to that party submitting the data to the QC.

Are there any safeguards for data?

Absolutely, the TCG QC values the confidentiality of all of its subjects. We will utilize the following as safeguards and standards:

  1. Participants will be assigned password-protected accounts
  2. Utilization of DE-IDENTIFIED PATIENT DATA
  3. All parties will be assigned a unique identifier for access and entry of patient-specific data - thus avoiding the use of patient's name into the TCG QC Database.

What information is collected and stored within the QC Database?

A Brief Overview of the type of Data Collected:

  1. Demographics
  2. Tumor-related Details
  3. Treatment Details
  4. Participant-entered Follow-up Details
  5. Miscellaneous Elements

Please see the Data Fields for a specific list of all elements that will be captured:

TCG Database Data Elements

Why Join?

  • We present to you an opportunity to provide data that has the potential to improve the quality and safety of treatment in patients receiving BCS and TARGIT.
  • There exists a societal benefit in that it will help facilitate possible future publication based on the data obtained within the QC.
  • Your involvement will help us establish best practices for patients treated with BCS and TARGIT.

Who will have access to the Database?

  • Access will be granted by the Committee only to accepted parties.
  • Parties will be granted unique password-protected accounts.
  • The Committee will utilize the Coordinator to provide user roles and restrictions as the Coordinator, and by extension, the Committee, deem fit.
  • Participants are NOT permitted to give any 3rd-party access to accounts.

What are some recruitment goals of the QC?

As we begin our project, we are searching for 10 sites to be included into our "Beta" phase. This will allow us to fine-tune and establish pathways for efficiency and accuracy with respect to the Database.

  • The "Beta" phase will occur for a minimum of 6 months
  • We STRONGLY encourage all interested parties to reach out to us and begin submission of the required materials - this will enable efficient incorporation into the QC once the Beta phase has ended.
  • Within the initial 2 years, we aim to accept approximately 30 sites.
  • Future goals with respect towards recruitment will be added as appropriate.

Is the information I am reading today accurate?

  • Yes. This landing page will be updated as appropriate with novel information. Contact us with any specific questions or concerns.
  • Specifically, the site will always include a "status" of the TCG QC
  • Currently, as indicated, we are in the "Beta" phase.

 What is the study population?

Please refer to the protocol for detailed inclusion and exclusion requirements.

Where can I find more information?

Feel free to reach out to our Coordinator, Mark Leshyk, for additional information at [email protected].

Also, refer to the following links provided:

Introductory Training Content

Acceptance Content List

TCG QC Group Introduction

Checklist for Submission

Quality of Life Form (1)

Quality of Life Form (2)

Protocol

TCG Database Data Elements