Industry sponsored studies
Step 1: PI communicates with PRO staff to execute CDA (Confidentiality Agreement) with sponsor and ensure that the Pediatric Research Office CRC bandwidth exists (if needed); initial CRC tentatively assigned.
Step 2: Sponsor conducts feasibility visit or call - typically requires completion of a questionnaire.
Step 3: If sponsor accepts VCU as site; PI receives regulatory package that may include budget.
Step 4:PI submits PROC (Protocol Review & Oversight Committee) feasibility questionnaire with optional input or assistance from CRC - an advance meeting w/ CRC is highly recommended (All Department of Pediatrics researchers will choose Children’s Hospital of Richmond).
Step 5: Go / No-go decision recommended from PROC. (This is a high-level feasibility questionnaire and PROC approval does not constitute study approval).
Step 6: "PRO conducts initial review of Sponsor docs, sends to SOMCT to create time grids and verify." study calendar (SOC vs. Research billing)
Step 7: SOMCT sends time grids - CRC will complete timegrid and calendar w/input from PI.
Step 8: "SOMCT sends draft workbook. PI and PRO staff conduct initial budget review, including" meeting w/ SOMCT if necessary to answer questions and discuss budget negotiation.
Step 9: SOMCT revises budget as necessary until receiving final approval from PRO to submit to Sponsor.
Step 10: "SOMCT submits budget to Sponsor, negotiates if necessary."
Step 11: "SOMCT seeks explicit approval from PRO, CRC and PI for any changes to budget."
Step 12: Optional: PRO obtains advance index to pay IRB submission cost.
Step 14: PI/CRC submits protocol to IRB.
Step 14: IRB protocol is approved typically with interim revisions.
Step 15: SOMCT submits to OnCore which triggers ancillaries to activate / invoice for setup fees.
Step 16: "Research team (PI, Co-Is, CRCs) complete trainings as required by Sponsor."
Step 17: Site Initiation Visit (SIV) is held.
Step 18: "Project begins - screening, enrollment…."