1. The interested investigator will read and become familiar with the DBDC Ancillary Studies Policy and Procedures document.
2. Contained within the policy document, the interested individuals will find thorough descriptions of the responsibilities of the PPAC, DCC, and Investigators.
3. Investigators wishing to conduct an ancillary study must complete the following materials:

• • DBDC Ancillary Study Proposal/Concept Application Form (Form A).
    • Completed forms are submitted to the PPAC in care of the DCC to the email address provided on the form.
    • The DCC will circulate the submitted Form A to the members of the PPAC with instructions that they are to send their comments to the DCC by a specified date, typically within 2 weeks.
  • The DCC will assist the PPAC Chair and Co-Chair to collate the comments and prepare a written memo to the Steering Committee specifying the recommendation for “approval," "disapproval," or "resubmit with additional information or revision.”
  • Complete each additional form referenced in Form A:
    • NIDDK Central Repositories Data and Resources Use Agreement (Form B)
    • Process to obtain samples from the NIDDK Biorepository (Form C)
    • DBDC Statistical Analysis Plan Template (Form D)

For resubmissions, please follow the steps outlined in Section 3.