Skip to content

GI Cancer Icon Changing outcomes for people with GIgastro-intestinal cancer

Donate Now
  • Make a Single Gift
  • Give a Monthly Gift
  • Give In Memory
  • A Gift In Your Will
  • Fundraise For Us
MENUMENU
  • Home
  • About
    • About Us
      • Chairman's Message
      • Board of Directors
      • Staff Members
      • Achievements
      • Scientific Advisory Committee
      • Upper GI and Lower GI Working Parties
      • Consumer Advisory Panel
      • Corporate Support
      • Annual Report
  • GI Cancer
    • What is GI cancer?
      • Oesophageal Cancer
      • Liver Cancer
      • Stomach Cancer
      • Gallbladder & Biliary Tract Cancer
      • Pancreatic Cancer
      • Gastro-intestinal Stromal Tumour (GIST)
      • Neuroendocrine Tumours (NETs)
      • Colorectal Cancer
      • Small Bowel Cancer
      • Anal Cancer
    • Resources
      • Videos
      • Cancer FAQ
      • Support Groups
      • Recommended Reading
      • Information Booklets
      • Recipes
      • Helpful Links
      • Newsletter Sign-up
    • News
      • Stories
      • Community Forums
  • Trials & Research
    • Clinical Trials
      • Trials - In Activation
      • Trials - Open
      • Trials - In Follow-up
      • Trials - Completed
      • Trials - Endorsed Studies
      • Participating Trial Centres
      • Clinical Trial FAQs
      • Genesis of a Clinical Trial
    • Research
      • Translational Research
      • Publications and Presentations
  • Health Professionals
    • AGITG
      • Membership
      • Achievements
      • Funding
    • Clinical Trials
      • AGITG Trial News
      • Trials - In Activation
      • Trials - Open
      • Trials - In Follow-up
      • Trials - Completed
      • Trials - Endorsed Studies
      • Participating Trial Centres
    • Research
      • Research Priorities
      • Upper GI and Lower GI Working Parties
      • Idea Generation Workshop
      • Endorsed Study Model
      • Translational Research Model
      • Publications and Presentations
    • Awards and Grants
      • AGITG Innovation Fund
      • New Concepts Symposium
      • John Zalcberg OAM Award
      • Merck-AGITG Clinical Research Fellowship in GI Cancer
      • Best of Posters & Fast Forward
      • Outstanding Site Award
      • AGITG Member Fundraiser of the Year Award
    • CommNETs
      • Presentations & Publications
      • Projects & Working Groups
      • Newsletters
      • Annual Meetings
      • CommNETs Committees
      • CommNETs Committee
      • Preceptorships
      • Policies
      • Contacts
    • News
      • Events & Education
        • Annual Scientific Meeting
  • ASM
  • Get Involved
    • The Gutsy Challenge
      • 2020 Gutsy Challenge Adventures
      • Mt Himlung Himal Ascent – Nepal 2020
      • 2019 Gutsy Challenge Adventures
      • Gutsy Challenge Adventures
      • Gutsy 100
    • Fundraise
      • Walk, Run or Ride for Research
      • Workplace Fundraising Ideas
      • Raise Your Fork for Research
      • Fundraising Tips
    • Donate
      • Where Does My Gift Go?
      • Make a Single Gift
      • Give a Monthly Gift
      • Direct Deposit Donation
      • A Gift In Your Will
      • Give In Memory
      • Workplace Giving
    • Volunteer
      • Corporate Support
  • Contact
  • Newsletter Sign-up
  • Member Login
GI Cancer Banner Image

Endorsed Study Model

Endorsed Study Model

The AGITG encourages investigators to submit concepts requiring ‘endorsement’ or ‘sponsorship’ for consideration via the internal processes in place.

Concepts that are ‘endorsed’ may involve AGITG liaising with the sponsoring institution to:

  • Conduct feasibility to gauge interest from a wide network of potential sites to participate in the study;
  • Advertise the study on the AGITG website;
  • Invite presentations at the ASM;
  • CAP review and feedback: lay summary of concept and master Participant Information Sheet and Consent Form.

Investigators requesting AGITG endorsement of concepts must agree to the following governance framework:

  1. AGITG Working Party reviews and approves the scientific merit of the research proposals. Investigators should advise of any time sensitivities in relation to Working Party review.
  2. AGITG Consumer Advisory Panel reviews the relevance of the concept from a consumer perspective.
  3. AGITG-CTC Operations Executive reviews and approves the resources allocated to conduct the study including the study budget.
  4. A TMC will be appointed to maintain adequate oversight on the trial if necesary.
  5. An AGITG Member is an Investigator on the study.
  6. The Institution submits six-monthly progress reports using the AGITG reporting template in a timely manner. In addition, the relevant AGITG Working Party throughout the year may request study update.
  7. If the pilot research develops a positive signal that warrants a larger-scale study:
      1. AGITG will have the expectation to review and act as Sponsor of the study, and the Chief Investigator and AGITG will work together to source additional grant or industry funding.
      2. A Coordinating Centre selected by the AGITG will coordinate the large-scale study.
      3. AGITG will request access to the pilot study data for the purposes of developing a larger-scale study.
  8. AGITG will be acknowledged in all publications arising from the pilot study to reflect the support provided to the investigator.
  9. Execution of an agreement including the above terms.

Endorsed Study Approval Mechanism

 

Share

Contact

For more information on the Endorsed Study Model contact Nisha Berthon-Jones, AGITG Clinical Research Manager.

Email: nisha@gicancer.org.au

Phone: (02) 9562 5223

© Copyright AGITG 2017 Privacy Terms and Conditions

Gastro Intestinal Cancer Institute Logo
Australasian Gastro-Intestinal Trials Group
  • Home
  • About
    • About Us
      • Chairman’s Message
      • Board of Directors
      • Staff Members
      • Achievements
      • Scientific Advisory Committee
      • Upper GI and Lower GI Working Parties
      • Consumer Advisory Panel
      • Corporate Support
      • Annual Report
  • GI Cancer
    • What is GI cancer?
      • Oesophageal Cancer
      • Liver Cancer
      • Stomach Cancer
      • Gallbladder & Biliary Tract Cancer
      • Pancreatic Cancer
      • Gastro-intestinal Stromal Tumour (GIST)
      • Neuroendocrine Tumours (NETs)
      • Colorectal Cancer
      • Small Bowel Cancer
      • Anal Cancer
    • Resources
      • Videos
      • Cancer FAQ
      • Support Groups
      • Recommended Reading
      • Information Booklets
      • Recipes
      • Helpful Links
      • Newsletter Sign-up
    • News
      • Stories
    • Engage
      • Community Forums
  • Trials & Research
    • Clinical Trials
      • Trials – In Activation
      • Trials – Open
      • Trials – In Follow-up
      • Trials – Completed
      • Trials – Endorsed Studies
      • Participating Trial Centres
      • Clinical Trial FAQs
      • Genesis of a Clinical Trial
    • Research
      • Translational Research
      • Publications and Presentations
  • Health Professionals
    • AGITG
      • Membership
      • Achievements
      • Funding
    • Clinical Trials
      • AGITG Trial News
      • Trials – In Activation
      • Trials – Open
      • Trials – In Follow-up
      • Trials – Completed
      • Trials – Endorsed Studies
      • Participating Trial Centres
    • Research
      • Research Priorities
      • Upper GI and Lower GI Working Parties
      • Idea Generation Workshop
      • Endorsed Study Model
      • Translational Research Model
      • Publications and Presentations
    • Awards and Grants
      • AGITG Innovation Fund
      • New Concepts Symposium
      • John Zalcberg OAM Award
      • Merck-AGITG Clinical Research Fellowship in GI Cancer
      • Best of Posters & Fast Forward
      • Outstanding Site Award
      • AGITG Member Fundraiser of the Year Award
    • CommNETs
      • Presentations & Publications
      • Projects & Working Groups
      • Newsletters
      • Annual Meetings
      • CommNETs Committees
      • CommNETs Committee
      • Preceptorships
      • Policies
      • Contacts
    • News
      • Events & Education
        • Annual Scientific Meeting
  • ASM
  • Get Involved
    • The Gutsy Challenge
      • 2020 Gutsy Challenge Adventures
      • Mt Himlung Himal Ascent – Nepal 2020
      • 2019 Gutsy Challenge Adventures
      • Gutsy Challenge Adventures
      • Gutsy 100
    • Fundraise
      • Walk, Run or Ride for Research
      • Workplace Fundraising Ideas
      • Raise Your Fork for Research
      • Fundraising Tips
    • Donate
      • Where Does My Gift Go?
      • Make a Single Gift
      • Give a Monthly Gift
      • Direct Deposit Donation
      • A Gift In Your Will
      • Give In Memory
      • Workplace Giving
    • Volunteer
      • Corporate Support
  • Contact

GI Cancer Icon Changing outcomes for people with GIgastro-intestinal cancer

Donate Now