Pre-Award Post-Award MILESTONE EXAMPLE: Approval of an IRB Application Approx. # of wks Nov Dec Jan Feb Mar April May June July Aug Sept Oct Nov Dec Jan Feb Mar A Writing protocol 2 weeks X B Writing consent form 1 week X C Complete IRB application 1 week X D Study team agrees to participate and PI submits application 1 week X E IRB approval process 5 weeks X X F Milestone Completion 10 weeks X Pre-Award Post-Award MILESTONE #1: {Insert milestone here and list steps below. Note the last step will be completion of the milestone.} Approx. # of wks Nov Dec Jan Feb Mar April May June July Aug Sept Oct Nov Dec Jan Feb Mar 1A 1B 1C 1D 1E 1F Milestone Completion
Pre-Award Post-Award MILESTONE #4: {Insert milestone here and list steps below. Note the last step will be completion of the milestone.} Approx. # of wks Nov Dec Jan Feb Mar April May June July Aug Sept Oct Nov Dec Jan Feb Mar 4A 4B 4C 4D 4E 4F Milestone Completion Pre-Award Post-Award MILESTONE #5: {Insert milestone here and list steps below. Note the last step will be completion of the milestone.} Approx. # of wks Nov Dec Jan Feb Mar April May June July Aug Sept Oct Nov Dec Jan Feb Mar 5A 5B 5C 5D 5E 5F Milestone Completion
Column Instructions: List all project related administrative activities. The following list is not exhaustive, so activities should be added per your project’s requirements. Column Instructions: State the amount time required to complete this activity. Column Instructions: State which milestone(s) are dependent on completion of this activity. Column Instructions: State which activities &/or milestones can be performed in parallel with this activity. Column Instructions: State which milestone(s) cannot be initiated until this activity/milestone is completed. NEEDED EQUIPMENT, DRUGS, SUPPLIES Order: (Delivery weeks)  N/A Order: (Delivery weeks)  N/A Order: (Delivery weeks)  N/A DRUG, BIOLOGICS, SPECIMENS REQUIRING MTA [ NOTE: MTAs can take 4-8+ weeks to obtain]  MTA Submission  N/A  MTA Approval  Shipment and Delivery of drug, biologics, specimens, etc…  N/A DRUG, BIOLOGICS, SPECIMENS, OR SERVICES REQUIRING PURCHASE ORDER [ NOTE: POs can take 1-6+ weeks to obtain]  Obtain DETAILED QUOTE from vendor for service/work to be done  N/A  Prepare a DETAILED SCOPE OF WORK to be performed by the Vendor  N/A DRUG, BIOLOGICS, SPECIMENS, OR SERVICES REQUIRING SUBCONTRACT [ NOTE: Subcontracts can take 6-8+ weeks to obtain ]  Prepare a DETAILED SCOPE OF WORK to be performed  N/A  Obtain detailed budget from sub-site including direct AND indirect costs for their site.  N/A STAFFING NEEDS or RESEARCH FELLOW REQUIREMENTS
 Draft job/fellow description and/or obtain Departmental approval  N/A  Post, interview, and hire  N/A  Training  N/A REGULATORY APPROVALS*  IACUC Protocol New Amend  N/A  IACUC Protocol Approval  Initial IRB Application New Amend  N/A  IRB Approval  Prewritten Order Submission  N/A  Prewritten Order Approval  CRRC/RDRC Submission  N/A  CRRC/RDRC Approval  IND/IDE Submission New Amend  N/A  IND/IDE Approval  IBC Submission New Amend  N/A  IBC Approval  RAC Submission  N/A  RAC Approval  Clinical Engineering Submission  N/A  Clinical Engineering Approval  TRU Submission  Community  Adult  Peds  VA  N/A