The Application also includes questions that help challenge the collaborative groups to anticipate potential future issues they will have to deal with, such as handling inquiries from patients and their families, developing educational materials on the specific diseases, and collecting and disseminating data on the genetic tests themselves. They also help facilitate interactions between the clinical and research experiences to serve the individuals and their families as well as obtain better information on the spectrum of rare diseases.

The CETT Collaborative Group should keep the following concepts in mind, as they will be required in the application and test development process.

• Information on clinical uses of the test; how the test results will be interpreted for clinical care providers, patients, and their families; and clinical utility regarding payor reimbursement.
• Methods to collect and store in publicly accessible databases the clinical information on each sample necessary to interpretation, while at the same time respecting confidentiality.
• Methods to collect and store test result information in publicly accessible databases.

• First Friday of the month – Collaborative Group must indicate through CETTrack no later than the first Friday of the month that a proposal will be submitted that month.
• Second Friday of the month – The completed Application and Supporting Documents must be uploaded into CETTrack. Each member of the Collaborative Group should upload their individual letter of commitment. The final version of the Application must be “submitted” in CETTrack by midnight EST on the second Friday of the month.
• Documents requiring a signature in which electronic signature is not an option should be priority mailed to:

  Andy Faucett, M.S., C.G.C.
  Emory University School of Medicine
  615 Michael Street, Suite 301
  Atlanta, GA 30322

• The goal of the CETT Program is a 3-month review cycle with updates by Andy Faucett on the status of the application. If a delay is likely, due to unforeseen events and/or requests for additional information, the applicants will be notified by the CETT Program Coordinator.
• An application received off-cycle will be considered in the next month.

During the Application development stage contact should be made with the CETT Program Education Coordinator and the NCBI contact via CETTrack. Contact must be verified in CETTrack before an Application can be submitted. Applications are reviewed initially by the CETT Program Scientific Advisor (Suzanne Hart, Ph.D.), the CETT Program Coordinator (Andy Faucett, M.S.), the CETT Program Education Coordinator (Kate Reed, MS) and the CETT Program National Center for Biotechnology Information (NCBI) liaison (Lisa Forman, Ph.D.). Often additional information will be requested during the Staff Review phase. Once the internal review is complete, the application is either returned with suggestions and questions to be resubmitted or forwarded to a Review Board Team made up of six members, including a

• clinical geneticist or genetic counselor certified by the American Board of Medical Genetics (ABMG) / American Board of Genetic Counseling (ABGC)
• molecular laboratory geneticist certified by either the ABMG or American Board of Pathology (ABP)
• biochemical laboratory geneticist certified by ABMG
• disease-specific advocate experienced in genetic disorders
• research scientist whose focus is genetic diseases
• healthcare provider whose primary focus is not genetics

The Review Board is assisted by the Review Board Coordinator (Roberta Pagon, M.D.).