Information for Researchers

NOTICE: All December receipt date applicants to PAR-DK-11-350 (Archive Biosamples, review date April 2, 2012) and 349 (Living Biobank, review date March 22, 2012) are asked to let the TNCC know their IRG score to remain under consideration for samples/subject access. Contact Julie Ford ( Julie.ford@epi.usf.edu) to submit IRG scores.

Applicants for the June 7, 2012 deadline for PAR-DK-11-350 (Archive Biosamples) must submit their request for conditional approval for access to samples to Julie Ford by May 7, 2012.

Ancillary Studies

TrialNet recognizes the importance of ancillary studies in the overall mission to better understand the natural history of type 1 diabetes, to devise means to prolong the honeymoon phase in subjects with new onset disease, and to prevent diabetes altogether. Ancillary studies that complement the objectives and thereby enhance the value of TrialNet studies are strongly encouraged.

Ancillary studies will be evaluated with careful consideration for their potential impact on the objectives and performance of TrialNet studies. Further, ancillary studies must not interfere with the continued interest and participation of the study subjects and investigators. To protect the interests of TrialNet, each ancillary study must be reviewed and approved by the Ancillary Studies Committee before its initiation. If an ancillary study is considered highly worthy by the Ancillary Studies Committee, but may cause deviation in the study protocol, or may interfere with the subjects’ interest or participation in TrialNet, then the study must be additionally reviewed and approved by the TrialNet Steering Committee before formal approval is granted. All approved ancillary studies will be reviewed yearly to evaluate their progress, and impact on TrialNet as a whole.

TrialNet welcomes the submission of ancillary studies as an adjunct to ongoing protocols.

• Archive Access Policy
• Subject Access Policy
• Archive Samples Access Application Form
• Subject Access Application Form
• TrialNet Ancillary Studies List

Current Funding Opportunities

T1D planned opportunities:

• Special Statutory Funding Program for Type 1 Diabetes Research (2012-2013)

NIDDK active funding opportunities:

• Research Using Subjects From The Type 1 Diabetes TrialNet Natural History Study (Living Biobank) (DP3) (PAR-11-349)
• Research Using Biosamples From Selected Type 1 Diabetes Clinical Studies (DP3) (PAR-11-350)
• Notice of Detailed Budget Correction for NIDDK PAR-11-349: Research Using Subjects From The Type 1 Diabetes TrialNet Natural History Study (Living Biobank) (DP3) and PAR-11-350: Research Using Biosamples From Selected Type 1 Diabetes Clinical Studies (DP3)
  
  
• Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01) (PAR-09-247)

NIAID active funding opportunity:

• Ancillary Studies in Immunomodulation Clinical Trials (R01) (RFA-AI-10-014)

NIH general announcement for all investigator-initiated research:

• NIH Parent Announcement for Investigator-Initiated Research

JDRF Funding Opportunity

• Biomarker Discovery/Validation For Staging And Assessment Of Type 1 Diabetes.
  

  An Ancillary Study Application must also be submitted to TrialNet for review and receive conditional approval prior to the JDRF RFA Review. Applications must be received by close of business on Monday March 26, 2012.

 

TN-01 Natural History

• Natural History Protocol Synopsis & Specimen Collection Schedule
• Natural History Specimen Inventory - All Subjects
• Natural History Specimen Inventory - Non-Diabetic Subjects
• Natural History Specimen Inventory - Diabetic Subjects
• Natural History Study - Ab Negative Control Subjects
• Natural History Demographic Report - Subjects with Stored Specimens
• Natural History HLA Typing Report – Subjects with Stored Specimens

TN-02 MMF/DZB

• MMF/DZB Protocol Synopsis & Specimen Collection Schedule
• MMF/DZB Specimen Inventory
• MMF/DZB Subject Demographic Report

TN-05 Anti-CD20

• Anti-CD20 Protocol Synopsis & Specimen Collection Schedule
• Anti-CD20 Specimen Inventory
• Anti-CD20 Subject Demographic Report

TN-08 GAD New Onset

• GAD New Onset Protocol Synopsis & Specimen Collection Schedule
• GAD New Onset Specimen Inventory & Subject Demographic Report
• GAD New Onset Specimen Inventory by TX Arm
• GAD New Onset HLA Typing Report

TN-09 CTLA-4 Ig

• CTLA-4 Ig Protocol Synopsis & Specimen Collection Schedule
• CTLA-4 Ig Specimen Inventory & Subject Demographic Report