What is the SOP for the review process?
A6. The following is the procedure for obtaining approval for a genetics sub-study for a planned CTN protocol: • Genetics sub-study PI submits proposal to Lead Investigator early on in the conceptual design of the clinical trial. The LI with the development team reviews for feasibility in context of the parent study and assurance that the genetic sub-study will not interfere with completing the parent protocol (i.e. it does not impose undue burden on subjects, staff, etc.; it will not interfere with enrollment, etc). • PI sends full proposal (see Q5) and letter of support from LI to the Executive Committee (EC) for review of feasibility and resources in the CTN and in context of comments and recommendations from LI makes approval/disapproval recommendation from the CTN perspective. EC can request additional information before the final determination is made. EC sends proposal and review comments to the NIDA Genetics Consortium Steering Committee/NIDA Access Committee for review (*This
