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Joining the Type 1 Diabetes TrialNet Study Group: Information for Affiliate Sites

What is the role of an Affiliate Site?

For the Natural History Study your role will be to:
  • Encourage subject participation and retention in study,
  • Conduct informed consent,
  • Perform phlebotomy,
  • Perform OGTTs,
  • Submitting protocols for IRB approval.

What are the benefits of becoming an Affiliate Site?

Benefits to you include:
  • Being able to actively recruit subjects into TrialNet Studies.
  • Receiving information and potential opportunity to participate in intervention studies for prevention of type 1 diabetes, and preservation of insulin secretion in new onset type 1 diabetes.
  • Participating in research with acknowledgement in TrialNet study publications.

What requirements does the Affiliate Site need to meet?

To be an Affiliate Site you must have/or obtain:
  • Complete New Affiliate Packet on file with the University of South Florida.
  • IRB approval for participation in the study protocol(s) by the Office of Human Research Protections.
  • HIPAA authorization.
  • Assignment to one of 20 Clinical Centers.
  • A designated physician as Principal Investigator and nurse designated as Site Coordinator.
  • Training of staff for procedures in protocols they will be conducting.

How does reimbursement work?

Affiliate Sites do not receive core funding. Affiliates are reimbursed based on study visits and test performed per subject. Reimbursement rates are established by the TrialNet Steering Committee and approved by NIDDK for each protocol.

What does participating in the Pathway to Prevention Study involve?

Affiliate Sites may choose to perform only Screening in the Pathway to Prevention protocol. Affiliate Sites that conduct Monitoring in this protocol or intend to conduct a TrialNet prevention or treatment protocol must have the capability to perform tolerance tests (intravenous glucose and oral glucose), maintain subject files, and carry out other various aspects of these protocols.


If you are interested in becoming a TrialNet Affiliate Site or a Participating Physician contact:

TrialNet Coordinating Center
Pediatric Epidemiology Center at the University of South Florida
3650 Spectrum Blvd
Suite 100
Tampa, FL 33612

trialnetinfo@epi.usf.edu

Toll free number is not available at this time. We apologize for the inconvenience!

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